Crystalline forms, and processes for their production

Abstract

Provided herein are crystalline forms (forms I, II, IIA, IIB, IIC and IID) of a compound of formula (I) as defined herein. Also provided herein are processes for the production of crystalline forms I, II, IIA, IIB, IIC and IID, and pharmaceutical compositions and therapeutic methods involving crystalline form I.

Description

[0001] CRYSTALLINE FORMS, AND PROCESSES FOR THEIR PRODUCTION This application claims priority from Australian provisional patent application no. 2022903939, filed on 21 December 2022, the entire contents of which are incorporated herein by this reference. Field The present disclosure relates to crystalline forms (forms I, II, IIA, IIB, IIC and IID) of a compound of formula (I) as defined herein. The present disclosure also relates to processes for the production of forms I, II, IIA, IIB, IIC and IID, and pharmaceutical compositions and therapeutic methods involving crystalline form I. Background Wound healing is an intricate process in which the skin or another organ or tissue, repairs itself after injury. In certain cases, wounds may be slow to heal or not heal at all. Many factors affect the healing of a wound, for example, the general health of the wounded subject, the age of the wounded subject, diseases such as diabetes, or other diseases that may affect circulation, the presence of infection, foreign objects or necrotic tissue, or in some instances, medication may affect the rate of wound healing. Furthermore, in some wounds imperfect regulation of wound resolution can result in fibrosis and excessive scar formation to leaving scar tissue that is functionally and cosmetically inferior to normal tissue. There is much research into improving wound healing and reducing scar tissue. However, there is a need to find agents that are capable of promoting wound healing. EBC-1013 is a semi-synthetic small molecule currently in development as a therapeutic agent. It targets different phases of the wound healing process, and the compound has been proposed for use on a range of difficult to manage wounds, including chronic non-healing ulcers, traumatic acute wounds, and burns, for reducing scarring, and for treating conditions such as bacterial infections, psoriasis and eczema. EBC-1013 has the structure: , and is described in, for example WO2014 / 169356 A1. Research and development to identify new therapies for the treatment of medical conditions such as wound healing, is a highly challenging task. It typically takes 10 years or longer for a new medicine to complete the journey from discovery to authorisation for use in the marketplace with there being a high rate of failure. Alongside being efficacious and safe to use, there are many other requirements for new medicinal products. For example, the active substance must be available in high levels of purity, with good reproducibility and being capable of being produced on large scale. The substance must also be physically and chemically stable over time, including on exposure to different temperature and humidity conditions. Many organic compounds exist in a variety of solid forms, including as amorphous material and in crystalline form, and for some molecules a large number of different crystalline forms (polymorphs) may exist. Polymorphs of a given compound can have different properties to each other, for example in respect of characteristics such as hygroscopicity, stability and solubility. Where a particular form of a compound is unstable or metastable, this can lead to difficulties during manufacture, storage and / or use of the compound. Identification of solid forms of a pharmaceutical active agent, and in particular the discovery of a sold form having the required properties, is in many cases a challenging and unpredictable task, with it being unknown how many polymorphs there may be, what their respective characteristics will be, or what synthetic process might provide access to a polymorph. It would be desirable to provide a solid form of the compound EBC-1013 having properties such as high stability and low hygroscopicity, and which can be produced in high purity in a reproducible and scalable manner. It would also be desirable to provide processes enabling provision of such a solid form of EBC-1013 reproducibly and in high purity. It would also be desirable to provide intermediate materials useful in such processes. Summary The present disclosure is based at least in part on the discovery of a polymorphic form of EBC-1013 (crystalline form I) having desirable properties for use in a pharmaceutical product, such as stability and lack of hygroscopicity. Furthermore, a process facilitating production of EBC-1013 form I via production of further polymorphic forms (crystalline forms II, IIA, IIB, IIC or IID), which enables the form I material to be produced reproducibly in high purity and good yield, and which is amenable to scale up, has also been discovered. In a first aspect, there is provided a crystalline form (Form I) of a compound of formula (I): (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.32θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 8.9, 10.2, 11.0, 12.1, 13.117.1, 18.3 and 18.5 degrees 2θ ±0.3 2θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 8.9, 9.7, 10.2, 11.0, 12.1, 13.1, 15.9, 17.1, 18.3 and 18.5 degrees 2θ ±0.32θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 7. In some embodiments, the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 77°C ±5°C and peak at 87°C ±5°C. In some embodiments, the crystalline form exhibits loss of not more than 0.3% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, the crystalline form is substantially unsolvated. In some embodiments, the compound of formula (I) has a purity of at least 98% by mass. In another aspect, there is provided a crystalline form (Form II) of a compound of formula (I): wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 13.3 and 20.0 degrees 2θ ±0.22θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 7.4, 9.4, 16.9, 17.9, 18.6, 20.9 and 22.5degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 7.4, 9.4, 13.3, 16.9, 17.9, 18.6, 20.0, 20.9 and 22.5 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 11. In some embodiments, the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 75°C ±5°C and peak at 81°C ±5°C. In some embodiments, the crystalline form exhibits loss of at least 1.5% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, the crystalline form is a solvate. In some embodiments, the solvate is an acetone solvate. In some embodiments, the compound of formula (I) has a purity of at least 97.5% by mass. In another aspect, there is provided a crystalline form (Form IIA) of a compound of formula (I):

[0002] (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.2 2θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 7.6, 11.3, 16.9, 17.8, 21.1 and 22.5 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 7.6, 9.5, 11.3, 13.3, 16.9, 17.8, 18.8, 19.9, 21.1 and 22.5 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 15. In some embodiments, the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 61°C ±5°C and peak at 68°C ±5°C. In some embodiments, the crystalline form exhibits loss of at least 1.5% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, the crystalline form is a solvate. In some embodiments, the solvate is an isopropanol solvate. In some embodiments, the compound of formula (I) has a purity of at least 97.5% by mass. In another aspect, there is provided a crystalline form (Form IIB) of a compound of formula (I):

[0003] (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.22θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 7.3, 11.1, 16.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 11.1, 13.1, 16.7, 17.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 17. In some embodiments, the crystalline form is a solvate. In some embodiments, the solvate is a tert-butanol solvate. In some embodiments, the compound of formula (I) has a purity of at least 97.5% by mass. In another aspect, there is provided a crystalline form (Form IIC) of a compound of formula (I): (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 9.4 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 7.3, 11.3, 13.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 7.3, 9.4, 11.3, 13.113.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 18. In some embodiments, the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 54°C ±5°C and peak at 62°C ±5°C. In some embodiments, the crystalline form exhibits loss of at least 1.25% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, the crystalline form is a solvate. In some embodiments, the solvate is a methyl ethyl ketone solvate. In some embodiments, the compound of formula (I) has a purity of at least 97.5% by mass. In another aspect, there is provided a crystalline form (Form IID) of a compound of formula (I): (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 7.3, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.2 2θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 13.1, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.22θ. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 20. In some embodiments, the crystalline form is a solvate. In some embodiments, the solvate is a tetrahydrofuran solvate. In some embodiments, the compound of formula (I) has a purity of at least 97.5% by mass. In another aspect, there is provided a process for producing crystalline form II, IIA, IIB, IIC or IID of a compound of formula (I) as defined herein, comprising: gradually adding water to a solution of the compound of formula (I) in an organic solvent selected from the group consisting of acetone, isopropanol, methyl ethyl ketone, THF and tert- butanol, producing a solid precipitate, and separating the solid precipitate from the water:organic solvent mixture. In some embodiments, the crystalline form is form II, and the organic solvent is acetone. In some embodiments, the water is added to the solution of the compound of formula (I) in organic solvent at a temperature in the range of from 20 to 30°C. In some embodiments, following addition of water, the mixture is cooled to a temperature in the range of from 0 to 5°C. In some embodiments, the mixture is cooled over a period in the range of from about 90 minutes to 3 hours, optionally about 2 hours. In some embodiments, following cooling, the mixture is maintained at the cooled temperature for a period in the range of from about 90 minutes to 3 hours, optionally about 2 hours. In some embodiments, the amount of organic solvent in which the compound of formula (I) is dissolved is in the range of from 2 to 15 volumes, optionally about 10 volumes. In some embodiments, the amount of water added to the solution of compound of formula (I) in organic solvent is in the range of from 5 to 40 volumes, optionally about 10 volumes. In some embodiments, the solid precipitate is separated from the water:organic solvent mixture by filtration. In some embodiments, the separated solid precipitate is washed with water, optionally an amount of water in the range of from 1 to 5 volumes, optionally about 2 volumes of water. In another aspect, there is provided a process for producing crystalline form I of a compound of formula (I) as defined herein, comprising: subjecting the crystalline form II, IIA, IIB, IIC or IID of a compound of formula (I) as defined herein, to vacuum conditions at a temperature of up to 70°C, thereby producing the crystalline form I. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is obtained by carrying out a process as defined herein. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions at a temperature in the range of from 30 to 60°C. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 6 to 120 hours. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 12 to 18 hours. In another aspect, there is provided a pharmaceutical composition comprising crystalline form I of the compound of formula (I) as defined herein, and a pharmaceutically acceptable excipient. In another aspect, there is provided crystalline form I of the compound of formula (I) as defined herein, or a pharmaceutical composition comprising the crystalline form, for use in treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns. In another aspect, there is provided a method of treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns in a subject, comprising administering an effective amount of crystalline form I of the compound of formula (I) as defined herein, or an effective amount of a pharmaceutical composition comprising the crystalline form, to the subject. In another aspect, there is provided use of crystalline form I of the compound of formula (I) as defined herein, for the manufacture of a medicament for treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns. Brief Description of the Drawings Figure 1 shows a photographic image of a batch of amorphous EBC-1013 Figure 2 shows an X-ray powder diffractogram of a batch of amorphous EBC-1013. Figure 3 shows the results of a DSC experiment conducted on a batch of amorphous EBC-1013. Figure 4 shows the results of a TG experiment conducted on a batch of amorphous EBC- 1013. Figure 5 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form I, overlaid with the diffractogram for a reference batch of EBC-1013 crystalline form I. Figure 6 shows a photographic image of a batch of EBC-1013 crystalline form I. Figure 7 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form I. Figure 8 shows the results of a DVS experiment conducted on a batch of EBC-1013 crystalline form I. Figure 9 shows the results of a TG / DSC experiment conducted on a batch of EBC-1013 crystalline form I. Figure 10 shows microscopic images of crystalline EBC-1013 crystalline form I. Figure 11 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form II. Figure 12 shows the results of a DVS experiment conducted on a batch of EBC-1013 crystalline form II produced from acetone:water. Figure 13 shows the results of a TG / DSC experiment conducted on a batch of EBC-1013 crystalline form II produced from acetone:water. Figure 14 shows a HPLC chromatogram for a batch of EBC-1013 crystalline form I, and an expanded region of the chromatogram. Figure 15 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form IIA produced from isopropanol:water. Figure 16 shows the results of a TG / DSC experiment conducted on a batch of EBC-1013 crystalline form IIA produced from isopropanol:water Figure 17 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form IIB produced from tert-butanol:water. Figure 18 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form IIC produced from methylethylketone:water. Figure 19 shows the results of a TG / DSC experiment conducted on a batch of EBC-1013 crystalline form IIC produced from methyl ethyl ketone:water. Figure 20 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form IID produced from tetrahydrofuran:water. Figure 21 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form I produced from EBC-1013 crystalline form IIA. Figure 22 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form I produced from EBC-1013 crystalline form IIB. Figure 23 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form I produced from EBC-1013 crystalline form IIC. Figure 24 shows an X-ray powder diffractogram of a batch of EBC-1013 crystalline form I produced from EBC-1013 crystalline form IID. Detailed Description Definitions Unless specifically defined otherwise, all technical and scientific terms used herein shall be taken to have the same meaning as commonly understood by one of ordinary skill in the art. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, preferred methods and materials are described. For the purposes of the present invention, the following terms are defined below. The present disclosure may refer to the contents of certain documents being incorporated herein by reference. In the event of any inconsistent teaching between the teaching of the present disclosure and the contents of those documents, the teaching of the present disclosure takes precedence. It is to be understood that if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art. As used herein, the term “and / or”, e.g., “X and / or Y” shall be understood to mean either "X and Y" or "X or Y" and shall be taken to provide explicit support for both meanings or for either meaning. As used herein, the term about, unless stated to the contrary, refers to + / - 10%, of the designated value. Throughout this specification, unless specifically stated otherwise or the context requires otherwise, reference to a single step, composition of matter, group of steps or group of compositions of matter shall be taken to encompass one and a plurality (i.e. one or more) of those steps, compositions of matter, groups of steps or groups of compositions of matter. Thus, as used herein, the singular forms "a", "an" and "the" include plural aspects unless the context clearly dictates otherwise. For example, reference to "a" includes a single as well as two or more; reference to "an" includes a single as well as two or more; reference to "the" includes a single as well as two or more and so forth. Unless otherwise indicated, terms such as "first," "second," etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to a “second” item does not require or preclude the existence of lower-numbered item (e.g., a “first” item) and / or a higher-numbered item (e.g., a “third” item). As used herein, the phrase “at least one of”, when used with a list of items, means different combinations of one or more of the listed items may be used and only one of the items in the list may be needed. The item may be a particular object, thing, or category. In other words, “at least one of” means any combination of items or number of items may be used from the list, but not all of the items in the list may be required. For example, “at least one of item A, item B, and item C” may mean item A; item A and item B; item B; item A, item B, and item C; or item B and item C. In some cases, “at least one of item A, item B, and item C” may mean, for example and without limitation, two of item A, one of item B, and ten of item C; four of item B and seven of item C; or some other suitable combination. As used herein, the word “comprise” and other forms of the word, such as “comprising” and “comprises,” means including but not limited to, and is not intended to exclude, for example, other additives, components, integers, or steps. As used herein, the term “subject” means an organism that is susceptible to a disease or condition. For example, the subject can be an animal, a mammal, a primate, a livestock animal (e.g., sheep, cow, horse, pig), a companion animal (e.g., dog, cat), or a laboratory animal (e.g., mouse, rabbit, rat, guinea pig, hamster). In some embodiments, the subject is a mammal. In some embodiments, the subject is human. As used herein, the term “treating” includes curing a disease or disorder, as well as alleviation of or reduction of symptoms associated with a disease or disorder or condition. The term treating also includes slowing the progression of a disease or disorder. As used herein, the term “prevention” includes prophylaxis, and includes reducing the likelihood of contracting a disease or disorder or a symptom thereof. Each embodiment of the present disclosure described herein is to be applied mutatis mutandis to each and every other embodiment unless specifically stated otherwise or required otherwise by context. Compound of Formula (I) The present disclosure relates to crystalline forms of the compound of formula (I): (I). The compound of formula (I) has the chemical name (1aR,1bR,1cS,2aR,3S,3aS,6aS,6bR,7R,8R,8aS)-3,3a,6b-trihydroxy-2a-(hydroxymethyl)-1,1,5,7- tetramethyl-4-oxo-1,1a,1b,1c,2a,3,3a,4,6a,6b,7,8-dodecahydro-8aHcyclopropa[ 5',6']benzo[1',2':7,8]azuleno[5,6-b]oxirene-8,8a-diyl dihexanoate. It is also referred to as 12,13- di-hexanoyl-6,7-epoxy-4,5,9,12,13,20-hexahydroxy-1-tigliaen-3-one, and as EBC-1013. It has the molecular formula C32H48O10, and a molecular weight of 592.73 g / mol. The compound of formula (I), its preparation, and / or use in therapeutic applications, are disclosed in WO2014 / 169356 A1, WO2018 / 018097 A1, WO2018 / 170559 A1, WO2020 / 206504 A1 and WO2020 / 252535 A1, the entire contents of each of which are incorporated herein by reference. The method described in WO2014 / 169356 A1 for the production of the compound of formula (I) results in production of amorphous material. Crystalline Form I In one aspect, there is provided a crystalline form (form I) of a compound of formula (I):

[0004] (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.32θ as measured by X-ray powder diffraction. Crystalline form I of the compound of formula (I) is producible as a highly crystalline material. The crystalline form is typically not a solvate, has good stability, and has low hygroscopicity. The crystalline form also has solubility characteristics suitable for use as a pharmaceutical active agent. The crystalline form can also be produced in good yield and with high purity. Characterisation of the crystalline form by X-ray powder diffraction indicates the presence of distinctive peaks at 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.3 2θ, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.2 2θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.1 2θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.3 2θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.2 2θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.1 2θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Characterisation of the Form I crystalline form by X-ray powder diffraction also indicates the presence of further distinctive peaks at 8.9, 10.2, 11.0, 12.1, 13.117.1, 18.3 and 18.5 degrees 2θ ±0.32θ, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. Thus, in some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 8.9, 10.2, 11.0, 12.1, 13.117.1, 18.3 and 18.5 degrees 2θ ±0.3 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 8.9, 10.2, 11.0, 12.1, 13.117.1, 18.3 and 18.5 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 8.9, 10.2, 11.0, 12.1, 13.117.1, 18.3 and 18.5 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 8.9, 9.7, 10.2, 11.0, 12.1, 13.1, 15.9, 17.1, 18.3 and 18.5 degrees 2θ ±0.3 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 8.9, 9.7, 10.2, 11.0, 12.1, 13.1, 15.9, 17.1, 18.3 and 18.5 degrees 2θ ±0.2 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 8.9, 9.7, 10.2, 11.0, 12.1, 13.1, 15.9, 17.1, 18.3 and 18.5 degrees 2θ ±0.1 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.22θ, and additionally comprises 6 or more, or 7 or more, or 8 or more, or 9 or more, or 10, peaks selected from the group consisting of 8.9, 10.2, 12.1, 13.1, 13.6, 14.2, 17.1, 18.3, 18.5 and 19.2 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 5.1, 6.5, 9.7, 13.1, 15.9, 18.3 and 18.5 degrees 2θ ±0.22θ, and additionally comprises 3 or more, or 4 or more, or 5 or more, or 6 or more, or 7, peaks selected from the group consisting of 8.9, 10.2, 12.1, 13.6, 14.2, 17.1 and 19.2 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 5.1, 6.5, 8.9, 9.7, 10.2, 12.1, 13.1, 13.6, 14.2, 15.9, 17.1, 18.3, 18.5 and 19.2 degrees 2θ ±0.2 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 7 (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). Exemplary conditions for characterisation of the form I crystalline form by X-ray powder diffraction include those set out at 2.9.33 of the European Pharmacopoeia 11.0, or at <941> of the US Pharmacopoeia. Exemplary conditions for characterisation of the form I crystalline form include use of a Bruker D8-Advance diffractometer, for example using the following conditions: Cu tube anode, 40 kV generator tension; 40 mA generator current; α1 wavelength of 1.54056 Å; α2 wavelength of 1.54439 Å; intensity ratio (α2 / α1) of 0.5; spinner off; 2θ° angular range of 3.00-50.00; 2θ° step size of 0.022θ°; and / or time per step of 0.5 seconds. Characterisation of a typical batch of the form I crystalline form by differential scanning calorimetry (DSC) has been shown to result in a DSC profile showing an endothermic peak with peak onset at about 77°C and peak at 87°C. Thus in some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 77°C ±15°C and peak at 87°C ±15°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 77°C ±10°C and peak at 87°C ±10°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 77°C ±5°C and peak at 87°C ±5°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 77°C ±2°C and peak at 87°C ±2°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 77°C ±1°C and peak at 87°C ±1°C. Exemplary conditions for characterisation of the form I crystalline form by DSC include those set out at 2.2.34 of the European Pharmacopoeia 11.0, or at <891> of the US Pharmacopoeia. Exemplary conditions for characterisation of the form I crystalline form by DSC include use of a Mettler Toledo DSC1, for example with Mettler software STAReThermal Analysis System. For example, DSC analysis may be carried out by recording heat flow from 30 to 250°C using a linear heating rate of 10°C / min, using a closed aluminium crucible having 40µl volume equipped with a pinhole, under nitrogen flow (e.g. 50 ml / min), using 5mg of sample for the measurement. Characterisation of a typical batch of the form I crystalline form by thermogravimetric analysis (TG) has been shown to result in low loss of mass during heating to 100°C. In some embodiments, the crystalline form exhibits loss of not more than 1.0% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, the crystalline form exhibits loss of not more than 0.5% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, the crystalline form exhibits loss of not more than 0.3% mass during heating to 100°C when subjected to thermogravimetric analysis. Exemplary conditions for characterisation of the form I crystalline form by TG include those set out at 2.2.34 of the European Pharmacopoeia 11.0, or at <891> of the US Pharmacopoeia. Exemplary conditions for characterisation of the form I crystalline form by TG (and DSC also) include use of a Mettler-Toledo TGA / DSC3+ simultaneous system with autosampler. For example, TG (and DSC) analysis may be carried out by recording heat flow from 30 to 250°C using a linear heating rate of 10°C / min, using a closed aluminium crucible having 100µl volume equipped with a pinhole, under nitrogen flow (e.g. 150 ml / min), using 10mg of sample for the measurement. Many organic compounds can form complexes in solvents in which they are reacted or from which they are precipitated or crystallized. These complexes are known as "solvates". For example, a complex with water is known as a "hydrate". Solvates, such as hydrates, exist when the compound incorporates solvent. In some embodiments, the crystalline form contains not more than 1.0% by weight of a solvent (e.g. an organic solvent and / or water). In some embodiments, the crystalline form contains not more than 0.5% by weight of a solvent (e.g. an organic solvent and / or water). In some embodiments, the crystalline form contains not more than 0.3% by weight of a solvent (e.g. an organic solvent and / or water). In some embodiments, the crystalline form contains not more than 0.2% by weight of a solvent (e.g. an organic solvent and / or water). In some embodiments, the crystalline form contains not more than 0.1% by weight of a solvent (e.g. an organic solvent and / or water). In some embodiments, the crystalline form is unsolvated or substantially unsolvated (e.g. it is substantially free of solvated water or organic solvent). Characterisation of a typical batch of the form I crystalline form by dynamic vapor sorption (DVS) analysis indicates that it has relatively low uptake of water on exposure to high relative humidity. In some embodiments, the crystalline form exhibits less than 0.2% gain in mass on exposure to 60% relative humidity conditions at 25°C. In some embodiments, the crystalline form exhibits less than 0.1% gain in mass on exposure to 60% relative humidity conditions at 25°C. In some embodiments, the crystalline form exhibits less than 0.2% gain in mass on exposure to 90% relative humidity conditions at 25°C. In some embodiments, the crystalline form exhibits less than 0.1% gain in mass on exposure to 90% relative humidity conditions at 25°C. Exemplary conditions for characterisation of the form I crystalline form include those set out at 2.9.39 of the European Pharmacopoeia 11.0, or at <1241> of the US Pharmacopoeia. Exemplary conditions for carrying out DVS analysis and determination of gain in mass on exposure to high relative humidity conditions include conducting analysis at a fixed temperature of 25 ± 0.1°C. As a preconditioning step, samples may be dried for 6 hours under a continuous flow of dry air (Relative Humidity, RH < 0.1 %) to establish the dry mass. The relative humidity may then be increased from 0% to 90% RH (in 10% RH steps) and then decreased to 0% RH in a similar way, until the completion of two full sorption / desorption cycles. The instrument may be run in a dm / dt mode (mass variation over time variation) and a fixed dm / dt value of 0.002% / min selected, in order to let equilibrium to be reached at each step. Experiments may for example be conducted with a maximum dm / dt stage time of 3 hours along with minimum dm / dt stability duration of one hour. In the last step, samples may for example be maintained for 3 hours under a flow of dry air to allow for weight equilibration. In some embodiments, a DVS Intrinsic1 system (Surface Measurement Systems Ltd UK) may be used to conduct measurements, for example with Intrinsic Control Software and software DVS Analysis Suite for elaboration. The identification of the form I crystalline form and the process for its production has enabled the preparation of high purity material. In some embodiments, the crystalline form I of the compound of formula (I) has a purity of at least 97%, or at least 97.5%, or at least 98%, or at least 98.5%, or at least 99%, or at least 99.5% (e.g. when measured by HPLC). Also provided herein is a compound of formula (I), having a purity of at least 97%, or at least 97.5%, or at least 98%, or at least 98.5%, or at least 99%, or at least 99.5% (e.g. when measured by HPLC). In some embodiments, the crystalline form I of the compound of formula (I) is a crystalline form obtained or obtainable by slurrying amorphous compound of formula (I) in a mixture of water:acetonitrile at room temperature (e.g. 90:10 or 95:5 v / v), or obtained or obtainable by subjecting the crystalline form II of the compound of formula (I), to vacuum conditions at a temperature of up to 70°C. Crystalline Forms II, IIA, IIB, IIC and IID The present disclosure also provides crystalline forms II, IIA, IIB, IIC and IID of the compound of formula (I). The crystalline forms are considered to be different pseudo- polymorphs, having similar XRPD patterns but being different solvates depending on the organic solvent used for their preparation. Thus, in another aspect, there is provided a crystalline form (form II) of a compound of formula (I): (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 13.3 and 20.0 degrees 2θ ±0.22θ as measured by X-ray powder diffraction using an x-ray wavelength of 1.5406 Å. Crystalline form II of the compound of formula (I) is producible as a highly crystalline material. The crystalline form can also be produced in good yield and with high purity, and also finds use as an intermediate form of the compound of formula (I) which can readily be converted into crystalline form I. Characterisation of the crystalline form by X-ray powder diffraction indicates the presence of distinctive peaks at 6.6, 13.3 and 20.0 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 13.3 and 20.0 degrees 2θ ±0.12θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 13.3 and 20.0 degrees 2θ ±0.22θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 13.3 and 20.0 degrees 2θ ±0.12θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Characterisation of the form II crystalline form by X-ray powder diffraction also indicates the presence of further distinctive peaks at 7.4, 9.4, 16.9, 17.9, 18.6, 20.9 and 22.5 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Thus, in some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.4, 9.4, 16.9, 17.9, 18.6, 20.9 and 22.5 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.4, 9.4, 16.9, 17.9, 18.6, 20.9 and 22.5 degrees 2θ ±0.1 2θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 7.4, 9.4, 13.3, 16.9, 17.9, 18.6, 20.0, 20.9 and 22.5 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 7.4, 9.4, 13.3, 16.9, 17.9, 18.6, 20.0, 20.9 and 22.5 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 6.613.3 and 20.0 degrees 2θ ±0.22θ, and additionally comprises 3 or more, or 4 or more, or 5 or more, or 6 or more, or 7, peaks selected from the group consisting of 7.4, 9.4, 16.9, 17.9, 18.6, 20.9 and 22.5 degrees 2θ ±0.1 2θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 11 (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). Characterisation of a typical batch of crystalline form II produced from acetone: water by differential scanning calorimetry (DSC) has been shown to result in a DSC profile showing an endothermic peak with peak onset at about 75°C and peak at 81°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 75°C ±15°C and peak at 81°C ±15°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 75°C ±10°C and peak at 81°C ±10°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 75°C ±5°C and peak at 81°C ±5°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 75°C ±2°C and peak at 81°C ±2°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 75°C ±1°C and peak at 81°C ±1°C. Characterisation of a typical batch of crystalline form II produced from acetone:water by thermogravimetric analysis (TG) has been shown to result in loss of 2.22% weight during heating to 100°C. In some embodiments, the crystalline form exhibits loss of at least 1.5% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, crystalline form II is a solvate. In some embodiments, crystalline form II is an acetone solvate. In some embodiments, crystalline form II is a solvate which has a molar ratio of the compound of formula (I) to the solvent in the range of from 4:1 to 2:1, or about a 3:1 molar ratio of the compound of formula (I) to the solvent. In another aspect, there is provided a crystalline form (form IIA) of a compound of formula (I):

[0005] (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.22θ as measured by X-ray powder diffraction using an x-ray wavelength of 1.5406 Å. Crystalline form IIA of the compound of formula (I) is producible as a highly crystalline material. The crystalline form can also be produced in good yield and with high purity, and also finds use as an intermediate form of the compound of formula (I) which can readily be converted into crystalline form I. Characterisation of the crystalline form by X-ray powder diffraction indicates the presence of distinctive peaks at 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.12θ as measured by X- ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.22θ as measured by X- ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.12θ as measured by X- ray powder diffraction, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Characterisation of the form IIA crystalline form by X-ray powder diffraction also indicates the presence of further distinctive peaks at 7.6, 11.3, 16.9, 17.8, 21.1 and 22.5 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Thus, in some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.6, 11.3, 16.9, 17.8, 21.1 and 22.5 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.6, 11.3, 16.9, 17.8, 21.1 and 22.5 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 7.6, 9.5, 11.3, 13.3, 16.9, 17.8, 18.8, 19.9, 21.1 and 22.5 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 7.6, 9.5, 11.3, 13.3, 16.9, 17.8, 18.8, 19.9, 21.1 and 22.5 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.22θ, and additionally comprises 2 or more, or 3 or more, or 4 or more, or 5 or more, or 6, peaks selected from the group consisting of 7.6, 11.3, 16.9, 17.8, 21.1 and 22.5 degrees 2θ ±0.1 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 15 (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). Characterisation of a typical batch of crystalline form IIA produced from isopropanol: water by differential scanning calorimetry (DSC) has been shown to result in a DSC profile showing an endothermic peak with peak onset at about 61°C and peak at 68°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 61°C ±15°C and peak at 68°C ±15°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 61°C ±10°C and peak at 68°C ±10°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 61°C ±5°C and peak at 68°C ±5°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 61°C ±2°C and peak at 68°C ±2°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 61°C ±1°C and peak at 68°C ±1°C. In some embodiments, the crystalline form exhibits loss of at least 1.5% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, crystalline form IIA is a solvate. In some embodiments, crystalline form IIA is an isopropanol solvate. In some embodiments, crystalline form IIA is a solvate which has a molar ratio of the compound of formula (I) to the solvent in the range of from 4:1 to 2:1, or about a 3:1 molar ratio of the compound of formula (I) to the solvent. In another aspect, there is provided a crystalline form (form IIB) of a compound of formula (I): (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.2 2θ as measured by X-ray powder diffraction using an x-ray wavelength of 1.5406 Å. Crystalline form IIB of the compound of formula (I) is producible as a highly crystalline material. The crystalline form can also be produced in good yield and with high purity, and also finds use as an intermediate form of the compound of formula (I) which can readily be converted into crystalline form I. Characterisation of the crystalline form by X-ray powder diffraction indicates the presence of distinctive peaks at 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.12θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.22θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.12θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. Characterisation of the form IIB crystalline form by X-ray powder diffraction also indicates the presence of further distinctive peaks at 7.3, 11.1, 16.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Thus, in some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.3, 11.1, 16.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.3, 11.1, 16.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.1 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 11.1, 13.1, 16.7, 17.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 11.1, 13.1, 16.7, 17.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.22θ, and additionally comprises 7 or more, or 8 or more, or 9 or more, or 10 or more, or 11 or more or 12, peaks selected from the group consisting of 7.3, 11.1, 16.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 17 (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, crystalline form IIB is a solvate. In some embodiments, crystalline form IIB is a tert-butanol solvate. In some embodiments, crystalline form IIB is a solvate which has a molar ratio of the compound of formula (I) to the solvent in the range of from 4:1 to 2:1, or about a 3:1 molar ratio of the compound of formula (I) to the solvent. In another aspect, there is provided a crystalline form (form IIC) of a compound of formula (I): wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 9.4 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction using an x-ray wavelength of 1.5406 Å. Crystalline form IIC of the compound of formula (I) is producible as a highly crystalline material. The crystalline form can also be produced in good yield and with high purity, and also finds use as an intermediate form of the compound of formula (I) which can readily be converted into crystalline form I. Characterisation of the crystalline form by X-ray powder diffraction indicates the presence of distinctive peaks at 6.5, 9.4 and 13.1 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 9.4 and 13.1 degrees 2θ ±0.12θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 9.4 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 9.4 and 13.1 degrees 2θ ±0.12θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Characterisation of the form IIC crystalline form by X-ray powder diffraction also indicates the presence of further distinctive peaks at 7.3, 11.3, 13.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å. Thus, in some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.3, 11.3, 13.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.3, 11.3, 13.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 7.6, 9.5, 11.3, 13.3, 16.9, 17.8, 18.8, 19.9, 21.1 and 22.5 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 7.3, 9.4, 11.3, 13.113.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 6.5, 9.4 and 13.1 degrees 2θ ±0.22θ, and additionally comprises 2 or more, or 3 or more, or 4 or more, or 5 or more, or 6, peaks selected from the group consisting of 7.3, 11.3, 13.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 18 (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). Characterisation of a typical batch of crystalline form IIC produced from methyl ethyl ketone: water by differential scanning calorimetry (DSC) has been shown to result in a DSC profile showing an endothermic peak with peak onset at about 54°C and peak at 62°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 54°C ±15°C and peak at 62°C ±15°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 54°C ±10°C and peak at 62°C ±10°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 54°C ±5°C and peak at 62°C ±5°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 54°C ±2°C and peak at 62°C ±2°C. In some embodiments, the crystalline form has a DSC profile showing an endothermic peak with peak onset at 54°C ±1°C and peak at 62°C ±1°C. In some embodiments, the crystalline form exhibits loss of at least 1.25% mass during heating to 100°C when subjected to thermogravimetric analysis. In some embodiments, crystalline form IIC is a solvate. In some embodiments, crystalline form IIC is a methyl ethyl ketone solvate. In some embodiments, crystalline form IIC is a solvate which has a molar ratio of the compound of formula (I) to the solvent in the range of from 4:1 to 2:1, or about a 3:1 molar ratio of the compound of formula (I) to the solvent. In another aspect, there is provided a crystalline form (form IID) of a compound of formula (I): (I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction using an x-ray wavelength of 1.5406 Å. Crystalline form IID of the compound of formula (I) is producible as a highly crystalline material. The crystalline form can also be produced in good yield and with high purity, and also finds use as an intermediate form of the compound of formula (I) which can readily be converted into crystalline form I. Characterisation of the crystalline form by X-ray powder diffraction indicates the presence of distinctive peaks at 6.4, 9.3 and 13.1 degrees 2θ ±0.22θ, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3 and 13.1 degrees 2θ ±0.12θ as measured by X-ray powder diffraction. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3 and 13.1 degrees 2θ ±0.12θ as measured by X-ray powder diffraction, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. Characterisation of the form IID crystalline form by X-ray powder diffraction also indicates the presence of further distinctive peaks at 7.3, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.2 2θ, obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å. Thus, in some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.3, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.2 2θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at any of 7.3, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 13.1, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.22θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 13.1, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at 6.4, 9.3 and 13.1 degrees 2θ ±0.22θ, and additionally comprises 4 or more, or 5 or more, or 6 or more, or 7 or more, or 8 or more or 9, peaks selected from the group consisting of 7.3, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.12θ (e.g. obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å). In some embodiments, the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 20 (e.g. obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å). In some embodiments, crystalline form IID is a solvate. In some embodiments, crystalline form IID is a tetrahydrofuran solvate. In some embodiments, crystalline form IID is a solvate which has a molar ratio of the compound of formula (I) to the solvent in the range of from 4:1 to 2:1, or about a 3:1 molar ratio of the compound of formula (I) to the solvent. The identification of the crystalline forms II, IIA, IIB, IIC and IID and processes for their production has enabled the preparation of high purity material. In some embodiments, the crystalline form II, IIA, IIB, IIC or IID of the compound of formula (I) has a purity of at least 97%, or at least 97.5%, or at least 98%, or at least 98.5%, or at least 99%, or at least 99.5% (e.g. when measured by HPLC). Also provided herein is a compound of formula (I), having a purity at least 97%, or at least 97.5%, or at least 98%, or at least 98.5%, or at least 99%, or at least 99.5% (e.g. when measured by HPLC). In some embodiments, the crystalline form II, IIA, IIB, IIC or IID of the compound of formula (I) is a crystalline form obtained or obtainable by gradually adding water to a solution of the compound of formula (I) (e.g. amorphous compound of formula (I)) in an organic solvent selected from the group consisting of acetone, isopropanol, methyl ethyl ketone, THF and tert- butanol, producing a solid precipitate, and separating the solid precipitate from the water:organic solvent mixture. In some embodiments, the organic solvent is acetone, and the crystalline form is form II. Exemplary conditions for characterisation of the form II, IIA, IIB, IIC and IID crystalline forms by X-ray powder diffraction include those set out at 2.9.33 of the European Pharmacopoeia 11.0, or at <941> of the US Pharmacopoeia. Exemplary conditions for characterisation of crystalline form II, IIA, IIB, IIC and IID include use of a Bruker D8-Advance diffractometer, for example using the following conditions: Cu tube anode, 40 kV generator tension; 40 mA generator current; α1 wavelength of 1.54056 Å; α2 wavelength of 1.54439 Å; intensity ratio (α2 / α1) of 0.5; spinner off; 2θ° angular range of 3.00-50.00; 2θ° step size of 0.02 2θ°; and / or time per step of 0.5 seconds. Exemplary conditions for characterisation of the form II, IIA, IIB, IIC and IID crystalline form by DSC include those set out at 2.2.34 of the European Pharmacopoeia 11.0, or at <891> of the US Pharmacopoeia. Exemplary conditions for characterisation of crystalline form II, IIA, IIB, IIC and IID by DSC include use of a Mettler Toledo DSC1, for example with Mettler software STAReThermal Analysis System. For example, DSC analysis may be carried out by recording heat flow from 30 to 250°C using a linear heating rate of 10°C / min, using a closed aluminium crucible having 40µl volume equipped with a pinhole, under nitrogen flow (e.g.50 ml / min), using 5mg of sample for the measurement. Exemplary conditions for characterisation of the form II, IIA, IIB, IIC and IID crystalline forms by TG include those set out at 2.2.34 of the European Pharmacopoeia 11.0, or at <891> of the US Pharmacopoeia. Exemplary conditions for characterisation of crystalline form II, IIA, IIB, IIC and IID by TG (and DSC also) include use of a Mettler-Toledo TGA / DSC3+ simultaneous system with autosampler. For example, TG (and DSC) analysis may be carried out by recording heat flow from 30 to 250°C using a linear heating rate of 10°C / min, using a closed aluminium crucible having 100µl volume equipped with a pinhole, under nitrogen flow (e.g. 150 ml / min), using 10mg of sample for the measurement. Preparation of Forms I, II, IIA, IIB, IIC and IID In another aspect, there is provided a process for producing the crystalline form II, IIA, IIB, IIC or IID of a compound of formula (I) as defined herein, comprising: gradually adding water to a solution of the compound of formula (I) in an organic solvent selected from the group consisting of acetone, isopropanol, methyl ethyl ketone, THF and tert- butanol, producing a solid precipitate, and separating the solid precipitate from the water:organic solvent mixture. It has been found that the process can provide the Form II, IIA, IIB, IIC or IID crystalline form reproducibly, in good yield, high purity, and in a scalable manner. The formation of crystalline form II, IIA, IIB, IIC or IID may for example be carried out under ambient atmosphere, or under an inert atmosphere such as nitrogen or argon. The organic solvent is selected from the group consisting of acetone, isopropanol, methyl ethyl ketone, THF and tert-butanol. The crystalline form obtained (II, IIA, IIB, IIC or IID) will depend on the organic solvent used. In some embodiments, the organic solvent is acetone, and the crystalline form obtained is form II. In some embodiments, the organic solvent is isopropanol, and the crystalline form obtained is form IIA. In some embodiments, the organic solvent is tert-butanol, and the crystalline form obtained is form IIB. In some embodiments, the organic solvent is methyl ethyl ketone, and the crystalline form is form IIC. In some embodiments, the organic solvent is tetrahydrofuran, and the crystalline form is form IID. In some embodiments, the volume:volume ratio of organic solvent:water is in the range of from 2:1 to 1:2, or about 1:1. In some embodiments, the amount of organic solvent in which the compound of formula (I) is dissolved is in the range of from 2 to 15 volumes, or from 5 to 15 volumes, optionally about 10 volumes. In some embodiments, the amount of water added to the solution of compound of formula (I) in organic solvent is in the range of from 5 to 40 volumes, or from 5 to 15 volumes, optionally about 10 volumes. As referred to herein, the term ‘volumes’ refers to the volume of organic solvent or water in mL, relative to the amount of compound of formula (I) in g. For example, in the case of a 1g batch of compound of formula (I), the use of 10 volumes of acetone refers to use of 10mL acetone. The compound of formula (I) may be dissolved in the organic solvent at any suitable temperature, for example at ambient temperature or at elevated temperature. In some embodiments, the compound of formula (I) is dissolved in the organic solvent at a temperature in the range of from 20 to 30°C. In some embodiments, the mixture containing organic solvent and the compound of formula (I) is agitated or stirred, e.g. during addition of water and following addition of water. Water is gradually added to the mixture of compound of formula (I) and organic solvent. In some embodiments water is added dropwise. In some embodiments, aliquots of water are added periodically. In some embodiments, water is added over a period in the range of from 10 minutes to 2 hours, or from 10 minutes to 1 hour, or from 10 minutes to 30 minutes, or from 30 minutes to 2 hours, or from 1 hour to hours. Water may be added to the mixture of compound of formula (I) and organic solvent at any suitable temperature, for example at ambient temperature. In some embodiments, the water is added to the solution of the compound of formula (I) in organic solvent at a temperature in the range of from 20 to 30°C. If desired, the production of crystalline form II, IIA, IIB, IIC or IID may be seeded, e.g. a small quantity of crystalline form II, IIA, IIB, IIC or IID may be added. A solid precipitate is produced. Typically a solid precipitate is produced following addition of water and aging the mixture for a suitable period, optionally with agitation / stirring and optionally with cooling. In some embodiments, following addition of water, the mixture is stirred for a period in the range of from 1 to 96 hours, or from 1 to 72 hours, or from 1 to 24 hours, or from 1 to 12 hours, or from 1 to 6 hours, or from 1 to 4 hours, or about 1, 2, 3 or 4 hours. In some embodiments, following addition of water, the mixture is cooled, for example to a temperature in the range of from 0 to 10°C, or from 0 to 5°C, or about 5°C. In some embodiments, the mixture is cooled over a period in the range of from 1 to 6 hours, or about 90 minutes to 3 hours, or about 2 hours. In some embodiments, following cooling, the mixture is maintained (e.g. with stirring) at the cooled temperature for a period in the range of from 1 to 96 hours, or from 1 to 72 hours, or from 1 to 24 hours, or from 1 to 12 hours, or from 1 to 6 hours, or from 1 to 4 hours, from about 90 minutes to 3 hours, or about 1, 2, 3 or 4 hours. The solid precipitate is separated from the liquid components, for example by decanting or filtration. In some embodiments, the solid precipitate is separated from the water:organic solvent mixture by filtration. If desired, the separated solid precipitate may be washed e.g. with water. A single washing step may be carried out, or multiple washing steps (e.g.2 or 3). In some embodiments, the separated solid precipitate is washed with water, optionally an amount of water in the range of from 1 to 5 volumes, optionally about 2 volumes of water. It has also been found that crystalline form I of the compound of formula (I) can be produced from each of crystalline form II, IIA, IIB, IIC and IID. Thus, in another aspect, there is provided a process for producing crystalline form I of a compound of formula (I) as defined herein, comprising: subjecting crystalline form II, IIA, IIB, IIC or IID of the compound of formula (I) as defined herein, to vacuum conditions at a temperature of up to 70°C, thereby producing crystalline form I. In some embodiments, the crystalline form II, IIA, IIB, IIC or IID used in the process is obtained by carrying out a process for producing crystalline form II, IIA, IIB, IIC or IID as defined herein. Crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions at a temperature of up to 70°C. In some embodiments, the temperature is up to 60°C, or up to 50°C, or up to 40°C. In some embodiments, elevated temperature conditions are used. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions at a temperature in the range of from 30 to 60°C. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions at a temperature in the range of from 30 to 35°C. The vacuum conditions may be applied for any suitable time period to effect conversion into crystalline form I. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 6 to 240 hours. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 6 to 120 hours. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 6 to 72 hours. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 6 to 24 hours. In some embodiments, crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 12 to 18 hours. Any suitable vacuum pressure may be applied to crystalline form II, IIA, IIB, IIC or IID. For example, a vacuum pressure in the range of from 0 to 100mbar may be applied, or from 0 to 50 mbar, or from 0.1 to 50 mbar, or from 0.1 to 25 mbar. Although less preferred, crystalline form I of the compound of formula (I) can also be produced directly from amorphous compound of formula (I). Accordingly, there is also provided a process for producing crystalline form I of a compound of formula (I) as defined herein, comprising: slurrying the compound of Formula (I) in a mixture of acetone and water; and separating the solid material from the acetone:water mixture. In some embodiments, the volume:volume ratio of acetone to water is in the range of from 95:5 to 90:10. In some embodiments, the slurrying step is carried out for a time period in the range of from 2 to 10 days. In some embodiments, the slurrying step is carried out at ambient temperature. Pharmaceutical Compositions In some embodiments, crystalline form I of the compound of formula (I) is provided in the form of a pharmaceutical composition, e.g. for use in treatment of a disease or disorder as defined herein. Accordingly, there is also provided a pharmaceutical composition comprising crystalline form I of the compound of Formula (I), and one or more pharmaceutically acceptable excipients. Suitably, the pharmaceutical composition comprises a pharmaceutically acceptable excipient or an acceptable excipient. By “pharmaceutically acceptable excipient” is meant a solid or liquid filler, diluent or encapsulating substance, or any other pharmaceutically acceptable excipient, such as a binder, disintegrant, lubricant, anti-caking agent, coloring, preservative, antioxidant, buffer or pH-adjusting agent, that may be safely used. The pharmaceutical compositions described herein may be provided in unit dosage form. As used herein, a "unit dosage form" means a composition in a form containing an amount of a compound or salt sufficient to provides a single dose or part-single dose of that compound or salt. Examples of unit dosage forms include pills, capsules, caplets, tablets, sachets, and the like. The pharmaceutical composition may be formulated for delivery by any suitable route of administration, such as for example topical, rectal, parenteral, sublingual, buccal, intravenous, intraarticular, intra-muscular, intra-dermal, subcutaneous, inhalational, intraocular, intraperitoneal, intracerebroventricular, transdermal and the like. Compositions can be prepared according to conventional methods, e.g. dissolution, suspension, mixing, granulating or coating methods. Examples of dosage forms include tablets, capsules, caplets, dispersions, suspensions, injections, solutions, syrups, troches, capsules, suppositories, aerosols, transdermal patches, impregnated (occlusive) dressing, creams, gels and the like. These dosage forms may also include injecting or implanting devices designed specifically for, or modified to achieve, controlled release of the pharmaceutical composition. Controlled release of the therapeutic agent may be effected, for example by coating the same with hydrophobic polymers including acrylic resins, waxes, higher aliphatic alcohols, polylactic and polyglycolic acids and certain cellulose derivates such as hydroxypropylmethyl cellulose. In addition, the controlled release may be affected by using other polymer matrices, liposomes and / or microspheres. Depending upon the particular route of administration, a variety of carriers, well known in the art may be used. For example, these carriers or excipients may be selected from a group including sugars, starches, cellulose and its derivates, malt, gelatine or other gelling agents, talc, calcium sulphate, vegetable oils, synthetic oils, alcohols and / or polyols, alginic acid, phosphate buffered solutions, emulsifiers, isotonic saline, and pyrogen-free water. Pharmaceutically acceptable carriers and acceptable carriers for systemic administration may for example be incorporated into the compositions of this invention. Pharmaceutical compositions of the present disclosure suitable for administration may for example be presented in discrete units such as syringes, vials, tubes, capsules, sachets or tablets each containing a predetermined amount of crystalline form I of the compound of formula (I), as a powder or granules or as a solution or a suspension in an aqueous liquid, a cyclodextrin solution, a non-aqueous liquid, an oil-in-water emulsion or a water-in-oil emulsion or as a solution or suspension in a cream or gel or as a suspension of micro- or nano-particles, including but not limited to silica or polylactide micro- or nano-particles. Such compositions may be prepared by any of the methods of pharmacy, but methods may for example include the step of bringing into association Form I of the compound of formula (I) with the carrier which constitutes one or more necessary ingredients. In many cases, the compositions are prepared by uniformly and intimately admixing active agent with liquid carriers or finely divided solid carriers or both, and then, if necessary, shaping the product into the desired presentation. In powders, the carrier may for example be a finely divided solid which is in a mixture with the finely divided active component. In tablets, the active component may for example be mixed with the carrier having the necessary binding capacity in suitable proportions and compacted into the shape and size desired. Suitable carriers for powders and tablets include magnesium carbonate, magnesium stearate, talc, sugar, lactose, pectin, dextrin, starch, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, a low melting wax, cocoa butter, and the like. The term "preparation" is intended to include the formulation of the active compound with encapsulating material as carrier providing a capsule in which the active component, with or without carriers, is surrounded by a carrier, which is thus in association with it. Similarly, cachets and lozenges are included. Tablets, powders, capsules, pills, cachets, and lozenges can be used as solid forms suitable for oral administration. For preparing suppositories, a low melting wax, such as admixture of fatty acid glycerides or cocoa butter, may for example first be melted and the active component then dispersed homogeneously therein, as by stirring. The molten homogenous mixture can then be poured into convenient sized molds, allowed to cool, and thereby to solidify. Formulations suitable for vaginal administration may for example be presented as pessaries, tampons, creams, gels, pastes, foams or sprays containing, in addition to the active ingredient, such carriers as are known in the art to be appropriate. Liquid form preparations include solutions, suspensions, and emulsions, for example, water or water-propylene glycol solutions. For example, parenteral injection liquid preparations can be formulated as solutions in aqueous 1,2-propanediol, dimethylsulfoxide (DMSO), aqueous solutions of gamma cyclodextrin or 2-hydroxypropyl-beta-cyclodextrin, saline solution or polyethylene glycol solution, with or without buffer. A preferred range of pH is 3.5-4.5. Suitable buffers buffer the preparation at pH 3.5-4.5 and include, but are not limited to, acetate buffer and citrate buffer. Crystalline form I of the compound of formula (I) may for example be formulated for parenteral administration (e.g. by injection, for example bolus injection or continuous infusion) and may be presented in unit dose form in ampoules, pre-filled syringes, small volume infusion or in multi-dose containers with an added preservative. The compositions may for example take such forms as suspensions, solutions, or emulsions in oily or aqueous vehicles, and may contain formulatory agents such as suspending, stabilising and / or dispersing agents. Alternatively, the active ingredient may be in powder form, obtained by aseptic isolation of sterile solid or by lyophilisation from solution, for constitution with a suitable vehicle, e.g. sterile, pyrogen-free water, before use. Aqueous solutions suitable for oral use can be prepared by, for example, dissolving the active component in water and adding suitable colorants, flavours, stabilizing and / or thickening agents, as desired. Aqueous suspensions suitable for oral use can be made by, for example, dispersing the finely divided active component in water with viscous material, such as natural or synthetic gums, resins, methylcellulose, sodium carboxymethylcellulose, or other well known suspending agents. Also included are solid form preparations which are intended to be converted, shortly before use, to liquid form preparations for oral administration. Such liquid forms include solutions, suspensions, and emulsions. These preparations may contain, in addition to the active component, colorants, flavours, stabilizers, buffers, artificial and natural sweeteners, dispersants, thickeners, solubilizing agents, and the like. For topical administration to the epidermis or other organ, crystalline form I of the compound of formula (I) may for example be formulated as a gel, ointment, emulsion, paste, cream or lotion, or as a transdermal patch. Gels may for example be prepared using suitable thickening agents and adding them to aqueous / alcoholic compositions of the active compound. Suitable thickening or gelling agents are known in the art, such as the polyvinyl carboxy polymer, Carbomer 940. Ointments and creams may, for example, be formulated with an aqueous or oily base with the addition of suitable thickening and / or gelling agents. Lotions may for example be formulated with an aqueous or oily base, and may also contain one or more emulsifying agents, stabilising agents, dispersing agents, suspending agents, thickening agents, or colouring agents. Formulations suitable for topical administration may also include solutions or suspensions that may be administered topically in the form of a bath or soak solution or a spray. These formulations may be suitably applied to combat skin irritations, insect bites and foot wounds. Formulations suitable for topical administration in the mouth include lozenges comprising active agent in a flavoured base, usually sucrose and acacia or tragacanth; pastilles comprising the active ingredient in an inert base such as gelatin and glycerin or sucrose and acacia; and mouthwashes comprising the active ingredient in a suitable liquid carrier. Solutions or suspensions may for example be applied directly to the nasal cavity by conventional means, for example with a dropper, pipette or spray. The formulations may be provided in single or multidose form. In the latter case of a dropper or pipette, this may be achieved by the patient administering an appropriate, predetermined volume of the solution or suspension. In the case of a spray, this may be achieved for example by means of a metering atomising spray pump. To improve nasal delivery and retention the active ingredient may be encapsulated with cyclodextrins, or formulated with agents expected to enhance delivery and retention in the nasal mucosa. Administration to the respiratory tract may also be achieved, for example by means of an aerosol formulation in which the active ingredient is provided in a pressurised pack with a suitable propellant such as a chlorofluorocarbon (CFC) for example, dichlorodifluoromethane, trichlorofluoromethane, or dichlorotetrafluoroethane, carbon dioxide, or other suitable gas. The aerosol may conveniently also contain a surfactant such as lecithin. The dose of drug may be controlled by provision of a metered valve. Alternatively, the active ingredient may for example be provided in the form of a dry powder, for example a powder mix of the compound in a suitable powder base such as lactose, starch, starch derivatives such as hydroxypropylmethyl cellulose and polyvinylpyrrolidone (PVP). Conveniently, in some embodiments, the powder carrier may form a gel in the nasal cavity. The powder composition may for example be presented in unit dose form, such as in capsules or cartridges of, e.g. gelatin, or blister packs from which the powder may be administered by means of an inhaler. In formulations intended for administration to the respiratory tract, including intranasal formulations, the active ingredient may for example be provided having a small average particle size, for example of the order of 1 to 10 microns or less. Such a particle size may be obtained by means known in the art, for example by micronization. Techniques and compositions for making dosage forms as described herein are described in the following references, all incorporated by reference herein: Modern Pharmaceutics, 4th Ed., Chapters 9 and 10 (Banker & Rhodes, editors, 2002); Lieberman et al., Pharmaceutical Dosage Forms: Tablets (1989); and Ansel, Introduction to Pharmaceutical Dosage Forms 8th Edition (2004). Pharmaceutical formulation techniques may also be used such as, for example, those disclosed in Remington's The Science and Practice of Pharmacy, 23rdEd., Elsevier (2020), or Remington's Pharmaceutical Sciences, 21stEdition, Mack Publishing, 2005. Further acceptable excipients are described in Powell, et al., Compendium of Excipients for Parenteral Formulations, PDA J Pharm Sci and Tech 1998, 52 238-311 and Nema et al., Excipients and Their Role in Approved Injectable Products: Current Usage and Future Directions, PDA J Pharm Sci and Tech 2011, 65 287-332. The contents of each of the aforementioned documents are incorporated herein by reference in their entirety. Crystalline forms and compositions described herein may be provided in an appropriate container, and labelled for treatment of an indicated condition. As discussed below, crystalline form I of the compound of formula (I) may be administered in combination with a further active agent. In some embodiments, the pharmaceutical composition comprising crystalline form I of the compound of formula (I) also contains a further therapeutic agent. Therapeutic Methods and Uses As discussed herein, EBC-1013 (the compound of formula (I)) has been proposed for use with a range of difficult to manage wounds, including chronic non-healing ulcers, traumatic acute wounds, and burns, for reducing scarring, and for treating conditions such as bacterial infections, psoriasis and eczema. Accordingly, the crystalline form of the present disclosure finds use in therapy of such conditions. In another aspect, there is provided crystalline form I of the compound of formula (I) as defined herein, for use in therapy. In another aspect, there is provided crystalline form I of the compound of formula (I) as defined herein, or a pharmaceutical composition comprising the crystalline form, for use in treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns. In another aspect, there is provided a method of treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns in a subject, comprising administering an effective amount of crystalline form I of the compound of formula (I) as defined herein, or an effective amount of a pharmaceutical composition comprising the crystalline form, to the subject. In another aspect, there is provided use of crystalline form I of the compound of formula (I) as defined herein, for the manufacture of a medicament for treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns. Any suitable route of administration may be employed for providing a human or non- human patient with the crystalline form of the present disclosure, or of the pharmaceutical composition comprising the crystalline form. For example, oral, topical, rectal, parenteral, sublingual, buccal, intravenous, intraarticular, intra-muscular, intra-dermal, subcutaneous, inhalational, intraocular, intraperitoneal, intracerebroventricular, transdermal and the like may be employed. The subject to be treated may be any subject including mammals, birds, fish and reptiles. In some embodiments, the subject is a human, a companion animal, a laboratory animal, a farming or working animal, a farmed bird, a racing animal or a captive wild animal such as those kept in zoos. Examples of suitable subjects include but are not limited to humans, dogs, cats, rabbits, hamsters, guinea pigs, mice, rats, horses, cattle, sheep, goats, deer, pigs, monkeys, marsupials, chickens, geese, canaries, budgies, crocodiles, snakes, lizards and the like. In particular embodiments, the subject is a mammalian subject such as a human, dog, cat, horse, cattle, sheep, goat, pig, deer, rat, guinea pig, kangaroo, rabbit or mouse. In some embodiments, the subject is a human. In some embodiments, the subject is male. In some embodiments, the subject is female. In some embodiments, the subject is adult. In some other embodiments, the subject is not a human, for example it may be a non- human animal, or a non-human mammal. An "effective amount" means an amount necessary at least partly to attain the desired response, for example in the case of wound healing, to initiate healing of a wound or to increase the rate of healing of a wound. The amount varies depending upon the health and physical condition of the individual to be treated, the taxonomic group of individual to be treated, the formulation of the composition, the assessment of the medical situation, and other relevant factors. Any appropriate dosage amount of crystalline form I, or of the pharmaceutical composition comprising the crystalline form, may be used. Dosage regimes may be adjusted to provide the optimum therapeutic response. For example, the therapy may be administered once per day or multiple times per day, or administered less frequently, e.g.. monthly or other suitable time intervals. In some embodiments, the crystalline form, or pharmaceutical composition comprising the same, is used for treating a wound, or for promoting wound healing. As used herein, the term “wound” refers to physical disruption of the continuity or integrity of tissue structure. Wounds include may be acute or chronic and include cuts and lacerations, surgical incisions or wounds, punctures, grazes, scratches, compression wounds, abrasions, friction wounds, decubitus ulcers (e.g. pressure or bed sores); thermal effect wounds (burns from cold and heat sources), chemical wounds (e.g. acid or alkali burns) or pathogenic infections (e.g. viral, bacterial or fungal) including open or intact boils, skin eruptions, blemishes and acne, ulcers, chronic wounds, (including diabetic-associated wounds such as lower leg and foot ulcers, venous leg ulcers and pressure sores), skin graft / transplant donor and recipient sites, immune response conditions, e.g. psoriasis and eczema, stomach or intestinal ulcers, oral wounds, including a ulcers of the mouth, damaged cartilage or bone, amputation wounds and corneal lesions. As used herein, the term “chronic wound” refers to a wound that has not healed within a normal time period for healing in an otherwise healthy subject. Chronic wounds may be those that do not heal because of the health of the subject, for example, where the subject has poor circulation or a disease such as diabetes, or where the subject is on a medication that inhibits the normal healing process. Healing may also be impaired by the presence of infection, such as a bacterial, fungal or parasitic infection. In some instances a chronic wound may remain unhealed for weeks, months or even years. Examples of chronic wounds include but are not limited to, diabetic ulcers, pressure sores and tropical ulcers. The term “promoting wound healing” as used herein, refers to improving wound healing compared to the wound healing that would be observed in an untreated wound. Promoting wound healing includes increasing the rate of wound healing, for example, the wound may heal at a rate that is hours, days or weeks faster than if the wound was left untreated. Promoting wound healing may also encompass the reduction of scar tissue in the healing or healed wound compared to that expected when a wound is left untreated. The term "wound healing" refers to the restoration of the tissue integrity, either in part or in full. The wound to be healed may be present in any organ or tissue, including internal organs or tissues or external tissues, such as skin. The wound may be the result of an injury, bite or burn. The organ or tissue may be any one or more of skin, muscle, liver, kidneys, lungs, heart, pancreas, spleen, stomach, intestines bladder, ovaries, testicles, uterus, cartilage, tendon, ligament, bone and the like. In particular embodiments, the wound is in the skin and / or muscle. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is administered soon after the wound is incurred. In other embodiments, the wound is a chronic wound that has failed to heal over days, weeks, months or years. In yet other embodiments, the wound is an existing wound which has failed to heal at a normal rate or has failed to respond to other therapies. In some embodiments, the administration of crystalline form I or pharmaceutical composition comprising the crystalline form, promotes the healing of a wound by increasing the rate of healing of the wound. In some embodiments, the administration promotes healing by reducing scarring or the amount of scar tissue that would form in the absence of treatment. In some embodiments, the treatment improves the cosmetic result or outcome or appearance of the wound once it has healed including for example improving skin pigmentation and / or improving hair regrowth compared to a wound that has not been treated. In particular embodiments of the promotion of wound healing, the therapy is preferably administered topically at or around the site, or administered intra-lesionally to provide a localised effect. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for treating, preventing and / or reducing scarring. The term “reducing scarring” or “reducing scar tissue” as referred to herein relates to an improved cosmetic result and / or reduced abnormal tissue caused by the healing of the wound compared to if the wound was left untreated. In some embodiments, reducing scar tissue includes reducing or minimising abnormal tissue, reducing or minimising changes in skin pigmentation and / or improving hair regrowth compared to when the wound is left untreated. Crystalline form I or the pharmaceutical composition comprising the same, may for example be applied to a wound which is healing or has healed with excessive scarring. Examples of such wounds are those that are producing or have produced keloid scars or hypertrophic scars. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for preventing or treating an infection, such as a bacterial infection or a fungal infection. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for preventing or treating a bacterial infection. The bacterial infection may be caused by a Gram-positive or Gram-negative bacteria, especially a Gram positive bacteria. Non-limiting examples of bacteria that are controlled by the crystalline form of the present disclosure include bacteria of the Genus Bacillus, such as B. subtilis, B. anthracis, B. cereus, B. firmis, B. licheniformis, B. megaterium, B. pumilus, B. coagulans, B. pantothenticus, B. alvei, B. brevis, B. circubins, B. laterosporus, B. macerans, B. polymyxa, B. stearothermophilus, B. thuringiensis and B. sphaericus; Staphlococcus such as S. aureus, S. epidermidis, S. haemolyticus, S. saprophyticus; Streptococcus, for example, S. pyrogenes, S. pneumoniae, S. alagactiae, S. dysgalactiae, S. equisimilis, S. equi, S. zooepidemicus, S. anginosus, S. salwarius, S. milleri, S. sanguis, S. mitior, S. mutans, S. faecalis, S. faecium, S. bovis, S. equinus, S. uberus and S. avium; Aerococcus spp., Gemella spp., Corynebacterium spp., Listeria spp., Kurthia spp., Lactobacillus spp., Erysipelothrix spp., Arachnia spp., Actinomyces spp., Propionibacterium spp., Rothia spp., Bifidobacterium spp., Clostridium spp., Eubacterium spp., Serratia spp., Klebsiella spp., Proteus spp., Enterococcus spp., Pseudomonas spp., Nocardia spp. and Mycobacterium spp. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for treating a wound infected with a bacterial infection. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for preventing or treating a fungal infection. The fungal infection may for example be one which is caused by filamentous fungi or yeasts. Non-limiting examples of fungi that are controlled by the crystalline form of the present disclosure include fungi of the Genus such as Aspergillus spp., Mucor spp., Trichtophyton spp., Cladosporium spp., Ulocladium spp., Curvularia spp., Aureobasidium spp., Candida albicans, Candida spp., Cryptococcus spp., Malessezia pachydermatis, Malessezia spp. and Trichosporon spp. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for treating a wound infected with a fungal infection. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for treating a wound infected by both bacterial and fungal infections, including in biofilms. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for preventing or treating an inflammatory skin disorder. In some embodiments the inflammatory skin disorder is psoriasis. In some other embodiments, the inflammatory skin disorder is eczema. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for treating an ulcer. In some embodiments, crystalline form I or the pharmaceutical composition comprising the same, is used for treating burns. In some embodiments, crystalline form I of the compound of Formula (I) is administered in combination with a further therapeutic agent, for example another therapeutic agent which is useful for one or more of treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns in a subject. The crystalline form I of the compound of Formula (I) may for example be administered separately to, simultaneously with or sequentially to the further therapeutic agent. For example, the crystalline form I of the compound of Formula (I) may be administered in combination with an antibiotic and / or an anti-inflammatory agent. Suitable antibiotics include beta-lactam antibiotics such as penicillin, ampicillin, amoxycillin, flucloxacillin, dicloxacillin, methacillin, carbenicillin and norocillin; cephalosporins such as cephalexin, cefacetrile, cefadroxil, cefaloglycin, cefalonium, cefalordidine, cefatrizine, ceaclor, cefproxil, cefuzonam, cefmetozole, loracarbef, cefminox, cefdinir, cefpodoxime, and cefpirome; carbapenems such as imipenem, meropenem, ertapenem, daripenem, panipenem and biapenem; aminoglycosids such as gentamicin, streptomycin, neomycin, kanamycin, vancomycin, erythromycin and asithromycin; oxazolidinones such as linezolid and posizolid, lincosamides such as clindamycin, quinolines such as oxolinic acid, ciprofloxacin, enoxacin, ofloxacin, lomefloxacin, levofloxacin and difloxacin; and sulfonamides such as sulfamethoxazole, sulfoadiazine and sulfacetamide, or mixtures such as amoxyclav (amoxycillin and clavulinic acid). Suitable anti-inflammatory agents include non-steroidal anti-inflammatory drugs such as meloxicam, piroxicam, oxicam, aspirin, difunisal, ibuprofen, dexibuprofen, naproxen, ketoprofen, indomethacin, tolmetin, mefenamic acid, numisulide and the like and corticosteroids such as hydrocortisone, prednisolone, methylprednisolone, prednisone, budesonide, betamethasone and dexamethasone. The crystalline form I of the compound of formula (I) can also be used in combination with other wound healing therapies such as dressings and ointments, lotions and gels. For example, it may be used in combination with silver dressings and dressings, ointments, lotions and gels comprising therapeutic agents such as iodine, aloe vera, paw paw, or medically active honeys such as manuka honey or other biologically or physiologically active agents such as antiviral agents, antifungal agents, and vitamins, such as A, C, D and E and their esters. The crystalline form I of the compound of formula (I) may also be used in combination with dressings that provide molecular structure for a wound. Such dressings may include polymeric films and cross-linked polymeric films, such as hyaluronic acid and related structures, including cross-linked hyaluronic acid. Those skilled in the art will appreciate that the disclosure herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the disclosure includes all such variations and modifications. The invention will now be described with reference to the following Examples which illustrate some preferred aspects of the present invention. However, it is to be understood that the particularity of the following description of the invention is not to supersede the generality of the preceding description of the invention. Examples EBC-1013 EBC-1013 may be prepared as described in, for example, WO2014 / 169356 A1. Analytical Procedures X-Ray Powder Diffractometry (XRPD): Instrument: The diffraction pattern was recorded with a Bruker D8-Advance diffractometer. Conditions: Tube anode : Cu Generator tension (kV) : 40 Generator current (mA) : 40 Wavelengths α1and α2(Å) : 1.54056, 1.54439 Intensity ratio (α2 / α1) : 0.500 Spinner : off Angular range (2θ°) : 3.00 - 50.00 Step size (2θ°) : 0.020 Time per step (sec) : 0.50 Solubility: Method: According to European Pharmacopoeia (EP) paragraph 5.11., the solubility of EBC- 1013 was determined in different solvents at room temperature. For methanol, acetonitrile and propylene glycol, in a proper flask, about 20 mg of EBC-1013 was accurately weighed. For all other solvents, in a proper flask, about 10 mg of EBC-1013 was accurately weighed. Differential Scanning Calorimetry (DSC): Instrument: Mettler Toledo DSC1 and Mettler software STAReThermal Analysis System Method: Heat flow was recorded from 30 to 250°C with linear heating rate (10°C / min), using closed aluminium crucibles (40µl volume) with a pinhole, under a 50 ml / min nitrogen flow. About 5 mg of powder was used for the measurement. Thermogravimetry and Differential Scanning Calorimetry (TG / DSC) The analyses were performed using a Mettler-Toledo TGA / DSC3+ simultaneous system with autosampler, using closed aluminium crucibles (100µl volume) with a pinhole. The TG / DSC signals were recorded from 30 to 250°C with linear heating rate (10°C / min) under a 150 ml / min nitrogen flow. About 10 mg of powder was used for each measurement. Dynamic Vapor Sorption (DVS) Analysis: Instrument: DVS Intrinsic1 system (Surface Measurement Systems Ltd UK) with Intrinsic Control Software and software DVS Analysis Suite for elaboration. Method: The analysis was run at a fixed temperature of 25 ± 0.1°C. The sample was dried for 6 hours under a continuous flow of dry air (Relative Humidity, RH < 0.1 %) to establish the dry mass (preconditioning step). The relative humidity was then increased from 0% to 90% RH (in 10% RH steps) and then decreased to 0% RH in a similar way, until the completion of two full sorption / desorption cycles. The instrument was run in a dm / dt mode (mass variation over time variation) and a fixed dm / dt value of 0.002% / min was selected, in order to let equilibrium to be reached at each step. A maximum dm / dt stage time of 3 hours along with minimum dm / dt stability duration of one hour were chosen. In the last step the samples were kept for 3 hours under a flow of dry air necessary for the weight equilibration. The hygroscopicity of the sample is determined using the following equation: Weight change = 100 x [(W2 - W1) / W1] Where: W1= weight of sample at the start of the experiment (25°C, 40% RH) W2= weight of sample at 25°C at 80% RH in the first absorption cycle (see V. Murikipudi et al., Pharmaceutical Development and Technology, 2013; 18(2): 348-358) CLASSIFICATION CRITERIA Not hygroscopic increase in mass is less than 0.2% Slightly hygroscopic increase in mass is less than 2.0% and equal to or greater than 0.2% Hygroscopic increase in mass is less than 15% and equal to or greater than 2% Very hygroscopic increase in mass is equal to or greater than 15% Deliquescent Sufficient water is absorbed to form a liquid High Performance Liquid Chromatography (HPLC): The purity of the reference material was determined by High Performance Liquid Chromatography (HPLC). Instrument: UHPLC Agilent 1290 Infinity II (dwell volume < 150 µl, max system pressure 18000 psi) equipped with G7117A DAD Detector, Thermostated Column Compartment and Cooling Sample Manager Compartment. Method Reference: ARM / 79-8034 HPLC Conditions: - Column: Halo RP-Amide (150 x 4.6 mm, 2.7 μm; P / N: 92814-707) - Flow: 1.0 ml / min - Injection Volume: 10.0 µl - Column Temperature: 10°C - Detector Wavelength: 249 nm - Sample Concentration: 1 mg / ml in Acetonitrile - Solvent A: Water + 0.1% formic acid / THF 95 / 5 (V / V) - Solvent B: Acetonitrile + 0.1% formic acid / THF 95 / 5 (V / V) Example 1: Amorphous EBC-1013 The starting point for the programme of research was amorphous EBC-1013. Briefly, the production process for producing amorphous EBC-1013 involved pooling column fractions containing EBC-1013, extraction into an organic phase, concentration of the organic phase, scratching of dry EBC-1013 from the flask, and drying under vacuum at 40°C for 12 hours to provide amorphous material. A photograph of a batch of amorphous EBC-1013 is provided in Figure 1. The sample had hard glassy flakes. A typical X-ray powder diffraction (XRPD) profile is shown in Figure 2, a typical differential scanning calorimetry (DSC) profile is shown in Figure 3, and typical thermogravimetric analysis (TG) profile shown in Figure 4. The XRPD profile was characteristic of amorphous material. DSC analysis showed an endothermic peak with onset at 37.8°C and apex at 46.8°C. The TG profile, performed at a rate of 10K / min, showed a 0.39% weight loss in the range 25-80°C. Degradation took place above 260°C. The purity profile of a typical batch of amorphous EBC-1013 is provided below: Property EBC-1013 Amorphous Appearance Pale yellow granular powder HPLC Assay 96.2% HPLC Assay a.s.f 96.4% Area% 99.25 Total Impurities 0.68% XRPD Amorphous Drawbacks of the amorphous material and the process for its preparation include: - lack of a final purification step; - lack of standardization of impurities, and limited batch-to-batch reproducibility; - difficulties in product recovery, due to need to mechanically recover product from container; - poor particle size control; - low glass-transition temperature; and - limited chemical and physical stability, hygroscopicity. Example 2: Unsuccessful attempts to Produce Crystalline EBC-1013 The following experiments are examples of unsuccessful attempts to produce a crystalline form of EBC-1013. a) 95:5 v / v heptane / ethyl acetate room temperature slurry 50mg of amorphous EBC-1013 was added to 1mL heptane / ethyl acetate 95:5 v / v solvent mixture. After solid addition the sample appeared to be dissolved with few particles in suspension, but after 15 minutes a gel formation was observed. This was manipulated with a spatula to break the gel and stirred with magnetic stirring at room temperature for 12 days. The product was filtered under vacuum. A sticky compound was recovered which after prolonged drying gave a powder consistency. XRPD analysis showed an amorphous phase with broad signal at 4.8° 2-theta. b) 90:10 v / v heptane / ethyl acetate room temperature slurry 50mg of amorphous EBC-1013 was added to 1mL heptane / ethyl acetate 90:10 v / v solvent mixture. After solid addition the sample appeared to be dissolved with few particles in suspension, but after 15 minutes a gel formation was observed. This was manipulated with a spatula to break the gel and stirred with magnetic stirring at room temperature for 12 days. The product was filtered under vacuum. A sticky compound was recovered which after prolonged drying gave a powder consistency. XRPD analysis showed an amorphous phase with broad signal at 4.8° 2-theta plus a small broad signal between 8.3 and 11.4° 2-theta. c) 90:10 v / v water / acetonitrile room temperature slurry 50mg of amorphous EBC-1013 was added to 1mL water / acetonitrile 90:10 v / v solvent mixture. After solid addition a sticky / gummy yellowish sample was observed. The stirrer bar was stuck to the solid. The mixture was stirred with magnetic stirring at room temperature for 4 days. The supernatant was removed and left to evaporate under 100mbar vacuum at room temperature, while the remaining gummy / sticky solid was dried at 100mbar vacuum at room temperature for 18 hours. No recovery was obtained from the mother liquor. The dried solid appeared partially vitreous and partially gummy. XRPD analysis showed an amorphous phase. d) 90:10 v / v Water / tetrahydrofuran room temperature slurry 50mg of amorphous EBC-1013 was added to 1mL water / tetrahydrofuran 90:10 v / v solvent mixture. After solid addition a sticky / gummy yellowish sample was observed. The stirrer bar was initially stuck to the solid. After a few hours off-white solid was observed on the vial bottom whilst the magnetic stirrer bar was able to agitate. The mixture was stirred with magnetic stirring at room temperature for 12 days. The supernatant was removed and left to evaporate under 100mbar vacuum at room temperature, while the remaining gummy / sticky solid was dried at 100mbar vacuum at room temperature for 18 hours. No recovery was obtained from the mother liquor. The dried solid appeared partially sticky. XRPD analysis showed an amorphous phase. e) 90:10 v / v heptane / ethyl acetate high temperature 50mg of amorphous EBC-1013 was added to 1mL heptane / ethyl acetate 90:10 v / v solvent mixture. The sample was then heated at 50°C. After a few minutes at 50°C, dissolution occurred. The mixture was allowed to cool to room temperature giving a jelly precipitate. The mixture was then heated again to 50°C leading to a clear solution. In order to induce precipitation, water was added dropwise. At the end of the water addition the supernatant appeared slightly opalescent. Different temperature conditions were applied in an attempt to induce precipitation: - 50°C for 1 hour under stirring - Room temperature for 1 hour. No precipitation was observed. The material was stored at low temperature (8-10°C) over the weekend. Two different phases were observed, clear on vial bottom and jelly on top. By vigorous agitation, the jelly was broken. After a few minutes a slightly opalescent solution was observed. This was allowed to evaporate at low temperature and 60°C. The product was vitreous, with no recovery. f) Water single solvent high temperature 50mg of amorphous EBC-1013 was added to 1mL water and heated at 90°C with stirring at 600 rpm. After 2 hours a slightly opalescent suspension and yellowish solid drops on the vial bottom were observed. The mixture was left at 90°C or 18 hours. After this time, an off-light suspension with yellowish solid drops on the vial bottom were observed. The supernatant was removed and left to evaporate under 100mbar vacuum at room temperature, while the remaining yellowish solid drops were dried at 100mbar vacuum at room temperature for 4 days. No recovery was obtained from the mother liquor. The dried solid drops appeared to be vitreous. They were then manipulated with a spatula and a white powder was obtained. XRPD analysis showed the material to be amorphous. Example 3: Preparation of Form I A) 50mg Scale Preparation 50mg of EBC-1013 was added to 1mL of water / acetone (90 / 10 v / v) solvent mixture previously prepared by leaving the mixture under stirring for five minutes. After solid addition, an apparently sticky / gummy yellowish sample was observed. The magnetic stirring bar became stuck to the sample while the supernatant was clear. After checking a few hours later, the stirring bar remained attached to the material, except for a few particles on the vial walls. The experiment was checked after one day, but the stirring bar was still stuck to the sticky / gummy solid. The mixture was left for a further three days. The mixture was treated as follows: the supernatant was removed and left to evaporate under 100mbar / room temperature, while the remaining sticky / gummy solid was dried at 100mbar / room temperature / 18 hours. No recovery was observed from evaporation of the mother liquor. The dried solid was a white solid that was not sticky / gummy, and gave a fine powder once manipulated with spatula. XRPD analysis indicated that a crystalline polymorph (referred to as form I) was achieved with a high crystallinity degree. B) 500mg Scale Preparation 20mL of a water / acetone (95 / 5 v / v) solvent mixture was added to a 100 mL glass reactor in a EasyMax102 System. Then, 500mg of amorphous EBC-1013 was charged into the reactor reaching a concentration of 25mg / mL. Immediately a translucent agglomerate on the reactor bottom was observed. It was stirred at 25°C (reactor jacket setpoint) with an anchor blade at 400 rpm. After one day, the translucent solid on the reactor bottom appeared whiter than the starting material, and in the middle of the reactor a small amount of off-white solid was observed on the walls. The experiment was left for further 6 days under the same condition. The supernatant was removed and left to evaporate at RT / 100mbar. After 7 days the supernatant solvent mixture was completely evaporated. Few particles were observed and not further analyzed. A white solid, slightly pale-yellow in the middle, was attached to the vial bottom. At the level of solvent reactor interface, a translucent slightly vitreous solid was observed. The reactor was left under RT / 100mbar vacuum for 40 hours. The white solid was removed from the reactor with a spatula. The achieved powder was analysed by XRPD, compared with a reference pattern, and was shown to be crystalline form I with high crystallinity degree. The amount recovered was 107.5 mg. The vitreous solid deposited on the reactor walls was also collected and analysed by XRPD, and shown to be crystalline form I. The amount recovered was 84.9 mg. A significant amount of powder was spread on the reactor walls and bottom, mostly as the result of solid manipulation. To recover the powder a washing step was carried out.10 mL of water was added to the reactor, the powder manipulated with a spatula, then recovered by vacuum filtration. The procedure was carried out three times. The combined powder was left to evaporate at RT / 100mbar vacuum / 18 hours, then analyzed by XRPD, and was shown to also be crystalline form I. The amount recovered was 102.3mg. An XRPD diffractogram for a batch of EBC-1013 crystalline form I obtained from the 500 mg scale up procedure (bottom line) and a reference batch of form I (top line) is shown in Figure 5. Example 4: Properties of EBC-1013: Form I Appearance EBC-1013 crystalline form I is a fine powder with soft lumps, as shown in Figure 6 . X-Ray Powder Diffraction (XRPD) An XRPD diffractogram for a typical batch of crystalline form I of EBC-1013 is shown in Figure 7. A list of 2θ peaks and their intensities is listed in the table below. Crystalline form I of EBC- 1013 was characterized by an X-ray powder diffraction (X-RPD) pattern obtained using the copper wavelengths λ1 and λ2 of 1.54056 Å and 1.54439 Å showing a crystalline structure and comprising distinctive reflections, expressed as 2θ degrees values, at 5.1, 6.5, 9.7 and 15.9 degrees 2θ ± 0.32θ, and additionally at 8.9, 10.2, 11.0, 12.1, 13.117.1, 18.3 and 18.5 degrees 2θ ± 0.32θ.

[0006] Dynamic Vapor Sorption (DVS) A batch of EBC-1013 crystalline form I was subjected to DVS analysis, as shown in Figure 8. The results are also summarised below: Relative Humidity (%) Change in Mass (%) 30 0.0 60 0.02 90 0.08 Thermogravimetric Analysis (TG) / Differential Scanning Calorimetry (DSC) DSC and TG analysis was carried out on a typical batch of crystalline form I of EBC- 1013, and the results are shown in Figure 9. Differential scanning calorimetry (DSC) analysis showed a peak with onset at 77.0°C and apex at 86.8°C. TG showed less than 0.01% loss of weight. The information supports that crystalline form I of EBC-1013 is not a solvate. Crystal Habit: Polarized Light Microscopy (PLM) PLM analysis showed that EBC-1013 crystalline form I contains small crystals, as shown in Figure 10. Solubility The solubility of 10mg batches of EBC-1013 crystalline form I in various solvents was analysed. The results are summarised in the table below. Approximate volume of solve ent SolubilityVolumnt in Solve in mlml per g of solute Water Practically insoluble 110 More than 10000: 11100 Ethanol Freely soluble 0.1 From 1 to 10: 10 Methanol Slightly soluble 20 From 100 to 1000: 938 Acetonitrile Sparingly soluble 2 From 30 to 100: 99 Acetone Freely soluble 0.1 From 1 to 10: 10 Ethyl Acetate Freely soluble 0.1 From 1 to 10: 9 n-Heptane Practically insoluble 110 More than 10000: 10967 Propylene glycol Soluble 0.3 From 10 to 30: 14 EBC-1013 crystalline form I is producible as a highly crystalline form of the molecule, as a fine powder, which is not hydrated and not solvated, and is not hygroscopic. Example 5: Preparation of EBC-1013 Form I: 1g Scale 1g of amorphous EBC-1013 was added to a 90:10 v / v water / acetone mixture at 50 mg / mL concentration and slurried for 7 days. The supernatant was then removed and the resulting material was a sticky solid that was attached to the reaction flask. The sticky solid was dried in the reaction flask, and then analysed by XRPD. XRPD analysis indicated that crystalline form I was obtained. However, the formation of a sticky solid attached to the reaction flask is sub-optimal for scale up to production plant scale. Example 6: Preparation of EBC-1013 Form II from Acetone:Water Amorphous EBC-1013 was dissolved in acetone (10 volumes vs EBC-1013 HPLC assay). Water (10 volumes vs EBC-1013 HPLC assay) was added dropwise to the mixture with stirring at 20-25°C. The resulting suspension was then cooled to 5°C over 2 hours and then stirred at 0-5°C for a further 2 hours. The resulting mixture was filtered, with the solid being washed with water (2 volumes vs EBC-1013 HPLC assay). XRPD analysis indicated the presence of a different crystalline polymorph, referred to as crystalline form II. Example 7: Properties of EBC-1013 Form II produced from Acetone:Water X-Ray Powder Diffraction (XRPD) An XRPD diffractogram for a typical batch of EBC-1013 crystalline form II produced from acetone:water is shown in Figure 11. A list of 2θ peaks and their intensities is listed in the table below. Crystalline form II of EBC-1013 was characterized by an X-ray powder diffraction (X-RPD) pattern obtained using the copper wavelengths λ1and λ2of 1.54056 Å and 1.54439 Å showing a crystalline structure and comprising distinctive reflections, expressed as 2θ degrees values, at 6.6, 13.3 and 20.0 degrees 2θ ± 0.22θ, and additionally at 7.4, 9.4, 16.9, 17.9, 18.6, 20.9 and 22.5 degrees 2θ ±0.22θ.

[0007] Dynamic Vapor Sorption (DVS) Crystalline form II EBC-1013 produced from acetone:water was subjected to DVS analysis, as shown in Figure 12. The results are also summarised below: Relative Humidity (%) Change in Mass (%) 30 0.59 60 1.35 90 2.03 Thermogravimetric Analysis (TG) / Differential Scanning Calorimetry (DSC) DSC and TG analysis was carried out on a typical batch of crystalline form II of EBC- 1013 produced from acetone:water, and the results are shown in Figure 13. Differential scanning calorimetry (DSC) analysis showed a peak with onset at 75.1°C and apex at 81.0°C. TG showed a 2.22% loss of weight associated with the transition at about 80°C. Crystalline form II EBC-1013 produced from acetone:water was found to be a crystalline solid which is partially solvated by acetone (3:1 molar ratio of EBC-1013 to acetone). The material is a workable and filterable solid which is readily obtainable from acetone:water crystallisation, and whose process for production facilitates removal / lowering of impurities. Typical quantities of acetone present in crystalline form II EBC-1013 produced from acetone: water, are about 1.5% by weight, which is higher than optimal. Example 8: Preparation of EBC-1013 Form I from EBC-1013 Form II It was found that EBC-1013 crystalline form I can be produced from EBC-1013 crystalline form II. A batch of EBC-1013 crystalline form II produced from water:acetone was dried for 16 hours at 30°C ±2°C at vacuum pressure in the range 0-50mbar. XRPD analysis of the resulting product indicated a solid-solid conversion of form II into form I. A further batch of EBC-1013 crystalline form II produced from water:acetone was also dried for 16 hours, at 35°C, under vacuum. XRPD analysis of the resulting product again indicated conversion into crystalline form I. Example 9: 20g Scale Preparation of EBC-1013 Form I from amorphous EBC-1013 via EBC-1013 Form II Amorphous EBC-1013 (20g) was dissolved in acetone (200 ml, 10 volumes vs EBC- 1013 HPLC assay). Water (200ml, 10 volumes vs EBC-1013 HPLC assay) was added dropwise to the mixture with stirring at 20-25°C. The resulting suspension was then cooled to 5°C over 2 hours and then stirred at 5°C for a further 2 hours. The resulting mixture was filtered, with the solid being washed with 40mL water (2 volumes vs EBC-1013 HPLC assay). XRPD analysis indicated that EBC-1013 crystalline form II was formed. The EBC-1013 crystalline form II was then dried for 16 hours at 30°C ±2°C at a vacuum pressure in the range 0-50mbar. XRPD analysis of the resulting product indicated that the material was EBC-1013 crystalline form I. The yield of form I was 17.6g (88%). The purity profile of the EBC-1013 crystalline form I produced from the 20g scale experiments is provided below, and the HPLC chromatogram is provided in Figure 14: Property EBC-1013 Form I Appearance Off-white granular powder HPLC Assay 99.7% HPLC Assay a.s.f 99.8% Area% 99.82% Total Impurities 0.14% XRPD Form I The process for preparing EBC-1013 crystalline form I via form II, facilitates access to EBC-1013 crystalline form I in high purity, and is more readily amenable to scale up than the process involving direct preparation of EBC-1013 crystalline form I from amorphous EBC-1013. Example 10: Accelerated Stability Studies Using EBC-1013 Form I EBC-1013 crystalline form I and amorphous EBC-1013 were subjected to accelerated stability studies, being assayed after storage for 1 month at 2-8°C, 25°C at 60% relative humidity, and at 40°C at 75% relative humidity. Data for EBC-1013 crystalline form I was also collected at 3 months. The results are shown in the tables below: T0 1 month 2-8°C 1 month 25°C 60% RH 1 month 40°C 75% RH Amorphous Form I Amorphous Form I Amorphous Form I Amorphous Form I Appearance Pale yellow Off-white Pale yellow Off-white Orange Off-white Pale yellow Off-white granular granular granular granular granular granular granular granular power powder power powder powder powder power powder HPLC Assay 96.2 99.7 95.2 99.0 96.1 99.7 95.9 99.5 HPLC Assay 96.4 99.8 95.5 99.1 96.2 99.8 96.2 99.5 a.s.f. Water 0.17 0.04 0.29 0.03 0.13 0.03 0.21 0.04 content (KF Coulometric) Total 0.68 0.14 0.73 0.05 0.68 <0.05 0.60 <0.05 impurities XRPD Amorphous Form I Amorphous Form I Amorphous Form I Amorphous Form I 3 months 3 months 3 months 2-8°C 25°C 60% 40°C 75% RH RH Form I Form I Form I Appearance Off-white Off-white Off-white granular granular granular powder powder powder HPLC Assay 101.1 98.8 98.3 HPLC Assay 101.2 98.9 98.4 a.s.f. Water 0.08 0.11 0.13 content (KF Coulometric) Total <0.05 0.11 0.06 impurities XRPD Form I Form I Form I As shown by the tables, EBC-1013 crystalline form I is stable on storage for up to 3 months, including at higher temperatures and higher relative humidity. Example 11: Forms IIA, IIB, IIC and IID Further crystalline forms of EBC-1013 were produced by preparation from different solvent systems, in which the acetone was replaced by another organic solvent, i.e. isopropanol, tert-butanol, methyl ethyl ketone or THF. The products had minor variation in their XRPD from the EBC-1013 crystalline form II produced from acetone:water, and are considered variants or pseudo-polymorphs, given their similarity in XRPD profile, and are again solvates containing the respective organic solvent. These are referred to respectively as forms IIA, IIB, IIC and IID. Amorphous EBC-1013 was dissolved in organic solvent (2-10 volumes vs EBC-1013 HPLC assay). Water (10-40 volumes vs EBC-1013 HPLC assay) was added dropwise to the mixture with stirring at 20-25°C. The resulting suspension was stirred for the time period indicated in the table below. The resulting mixture was filtered, with the solid being washed with water (2 volumes vs EBC-1013 HPLC assay). Organic Precipitation XRPD Solvate Solvent Isopropanol Yes Form IIA Yes Tert-butanol Yes Form IIB Yes Methyl ethyl Yes Form IIC Yes ketone Tetrahydrofuran Yes Form IID Yes EBC-1013 Form IIA produced from Isopropanol:Water A representative XRPD for a batch of EBC-1013 crystalline form IIA produced from isopropanol and water is provided in Figure 15. A list of 2θ peaks and their intensities for the EBC-1013 crystalline form IIA produced from isopropanol:water is listed in the table below.

[0008] DSC and TG analysis was carried out on a typical batch of crystalline form IIA of EBC- 1013 produced from isopropanol:water, and the results are shown in Figure 16. DSC analysis showed a peak with onset at 61.0°C and apex at 67.5°C. TG showed a 1.64% loss of weight associated with the transition. EBC-1013 Form IIB produced from Tert-butanol:Water A representative XRPD for a batch of EBC-1013 crystalline form IIB produced from tert- butanol and water is provided in Figure 17. A list of 2θ peaks and their intensities for the EBC- 1013 crystalline form IIB produced from tert-butanol:water is listed in the table below.

[0009] EBC-1013 Form IIC produced from Methyl Ethyl Ketone:Water A representative XRPD for a batch of EBC-1013 crystalline form IIC produced from methyl ethyl ketone and water is provided in Figure 18. A list of 2θ peaks and their intensities for the EBC-1013 crystalline form IIC produced from methylethylketone:water is listed in the table below.

[0010] Thermogravimetric Analysis (TG) / Differential Scanning Calorimetry (DSC) DSC and TG analysis was carried out on a typical batch of crystalline form IIC produced from methyl ethyl ketone and water of EBC-1013, and the results are shown in Figure 19. Differential scanning calorimetry (DSC) analysis showed a peak with onset at 53.7°C and apex at 62.4°C. TG showed a 1.40% loss of weight associated with the transition. EBC-1013 Form IID produced from Tetrahydrofuran:Water A representative XRPD for a batch of EBC-1013 crystalline form IID produced from tetrahydrofuran and water is provided in Figure 20. A list of 2θ peaks and their intensities for the EBC-1013 crystalline form IID produced from tetrahydrofuran:water is listed in the table below.

[0011] Example 12: Conversion of EBC-1013 Forms IIA IIB, IIC and IID to Form I It has also been found that, on drying EBC-1013 crystalline forms IIA, IIB, IIC and IID under appropriate conditions, the batches of material can again be converted into EBC-1013 crystalline form I. A batch of EBC-1013 crystalline form IIA produced from isopropanol:water was dried under vacuum for 16 hours at 40°C. XRPD analysis indicated the presence of EBC-1013 crystalline form I (Figure 21). A batch of EBC-1013 crystalline form IIB produced from tert-butanol:water was dried under vacuum. XRPD analysis indicated the presence of EBC-1013 crystalline form I (Figure 24). A batch of EBC-1013 crystalline form IIC produced from methylethylketone:water was dried under vacuum. XRPD analysis indicated the presence of EBC-1013 crystalline form I (Figure 22). A batch of EBC-1013 crystalline form IID produced from tetrahydrofuran:water was dried under vacuum. XRPD analysis indicated the presence of EBC-1013 crystalline form I (Figure 23).

Claims

Claims 1. A crystalline form (Form I) of a compound of formula (I):wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 9.7 and 15.9 degrees 2θ ±0.32θ as measured by X-ray powder diffraction.

2. The crystalline form as claimed in claim 1, wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 8.9, 10.2, 11.0, 12.1, 13.117.1, 18.3 and 18.5 degrees 2θ ±0.32θ.

3. The crystalline form as claimed in claim 2, wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 5.1, 6.5, 8.9, 9.7, 10.2, 11.0, 12.1, 13.1, 15.9, 17.1, 18.3 and 18.5 degrees 2θ ±0.32θ.

4. The crystalline form as claimed in any of claims 1 to 3, wherein the crystalline form exhibits an X-ray powder diffraction pattern substantially as shown in Figure 7.

5. The crystalline form as claimed in any of claims 1 to 4, wherein the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 77°C ±5°C and peak at 87°C ±5°C.

6. The crystalline from as claimed in any of claims 1 to 5, wherein the crystalline form exhibits loss of not more than 0.3% mass during heating to 100°C when subjected to thermogravimetric analysis.

7. The crystalline form as claimed in any of claims 1 to 6, wherein the crystalline form is substantially unsolvated.

8. The crystalline form as claimed in any of claims 1 to 7, wherein the compound of formula (I) has a purity of at least 98% by mass.

9. A crystalline form (Form II) of a compound of formula (I):wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.6, 13.3 and 20.0 degrees 2θ ±0.22θ as measured by X-ray powder diffraction.

10. The crystalline form as claimed in claim 9, wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising one or more peaks at 7.4, 9.4, 16.9, 17.9, 18.6, 20.9 and 22.5 degrees 2θ ±0.22θ.

11. The crystalline form as claimed in claim 10, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising peaks at each of 6.6, 7.4, 9.4, 13.3, 16.9, 17.9, 18.6, 20.0, 20.9 and 22.5 degrees 2θ ±0.22θ.

12. The crystalline form as claimed in claim 11, wherein the crystalline form exhibits an X- ray powder diffraction pattern substantially as shown in Figure 11.

13. The crystalline form as claimed in any of claims 9 to 12, wherein the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 75°C ±5°C and peak at 81°C ±5°C.

14. The crystalline from as claimed in any of claims 9 to 13, wherein the crystalline form exhibits loss of at least 1.5% mass during heating to 100°C when subjected to thermogravimetric analysis.

15. The crystalline form as claimed in any of claims 9 to 14, wherein the crystalline form is a solvate.

16. The crystalline form as claimed in claim 15, wherein the solvate is an acetone solvate.

17. The crystalline form as claimed in any of claims 9 to 16, wherein the compound of formula (I) has a purity of at least 97.5% by mass.

18. A crystalline form (Form IIA) of a compound of formula (I):(I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.7, 9.5, 13.3, 18.8 and 19.9 degrees 2θ ±0.2 2θ as measured by X-ray powder diffraction.

19. The crystalline form as claimed in claim 18, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising one or more peaks at 7.6, 11.3, 16.9, 17.8, 21.1 and 22.5 degrees 2θ ±0.22θ.

20. The crystalline form as claimed in claim 19, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising peaks at each of 6.7, 7.6, 9.5, 11.3, 13.3, 16.9, 17.8, 18.8, 19.9, 21.1 and 22.5 degrees 2θ ±0.22θ.

21. The crystalline form as claimed in claim 18, wherein the crystalline form exhibits an X- ray powder diffraction pattern substantially as shown in Figure 15.

22. The crystalline form as claimed in any of claims 18 to 21, wherein the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 61°C ±5°C and peak at 68°C ±5°C.

23. The crystalline from as claimed in any of claims 18 to 22, wherein the crystalline form exhibits loss of at least 1.5% mass during heating to 100°C when subjected to thermogravimetric analysis.

24. The crystalline form as claimed in any of claims 18 to 23, wherein the crystalline form is a solvate.

25. The crystalline form as claimed in claim 24, wherein the solvate is an isopropanol solvate.

26. The crystalline form as claimed in any of claims 18 to 25, wherein the compound of formula (I) has a purity of at least 97.5% by mass.

27. A crystalline form (Form IIB) of a compound of formula (I):(I), wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3, 13.1 and 17.7 degrees 2θ ±0.22θ as measured by X-ray powder diffraction.

28. The crystalline form as claimed in claim 27, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising one or more peaks at 7.3, 11.1, 16.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.22θ.

29. The crystalline form as claimed in claim 28, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 11.1, 13.1, 16.7, 17.7, 18.4, 18.7, 19.0, 19.7, 19.8, 20.9, 21.6, 22.0 and 22.2 degrees 2θ ±0.22θ.

30. The crystalline form as claimed in claim 27, wherein the crystalline form exhibits an X- ray powder diffraction pattern substantially as shown in Figure 17.

31. The crystalline form as claimed in any of claims 27 to 30, wherein the crystalline form is a solvate.

32. The crystalline form as claimed in claim 31, wherein the solvate is a tert-butanol solvate.

33. The crystalline form as claimed in any of claims 27 to 32, wherein the compound of formula (I) has a purity of at least 97.5% by mass.

34. A crystalline form (Form IIC) of a compound of formula (I):wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.5, 9.4 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction.

35. The crystalline form as claimed in claim 34, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising one or more peaks at 7.3, 11.3, 13.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.22θ.

36. The crystalline form as claimed in claim 35, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising peaks at each of 6.5, 7.3, 9.4, 11.3, 13.113.4, 16.5, 18.1, 18.8, 19.6, 20.3, 20.9 and 21.9 degrees 2θ ±0.22θ.

37. The crystalline form as claimed in claim 34, wherein the crystalline form exhibits an X- ray powder diffraction pattern substantially as shown in Figure 18.

38. The crystalline form as claimed in any of claims 34 to 37, wherein the crystalline form has a differential scanning calorimetry profile showing an endothermic peak with peak onset at 54°C ±5°C and peak at 62°C ±5°C.

39. The crystalline form as claimed in any of claims 34 to 38, wherein the crystalline form exhibits loss of at least 1.25% mass during heating to 100°C when subjected to thermogravimetric analysis.

40. The crystalline form as claimed in any of claims 34 to 39, wherein the crystalline form is a solvate.

41. The crystalline form as claimed in claim 40, wherein the solvate is a methyl ethyl ketone solvate.

42. The crystalline form as claimed in any of claims 34 to 41, wherein the compound of formula (I) has a purity of at least 97.5% by mass.

43. A crystalline form (Form IID) of a compound of formula (I):(I),wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising peaks at each of 6.4, 9.3 and 13.1 degrees 2θ ±0.22θ as measured by X-ray powder diffraction.

44. The crystalline form as claimed in claim 42, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising one or more peaks at 7.3, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.22θ.

45. The crystalline form as claimed in claim 43, wherein the crystalline form exhibits an X- ray powder diffraction pattern comprising peaks at each of 6.4, 7.3, 9.3, 13.1, 13.2, 16.6, 17.8, 19.6, 20.1, 20.9 and 22.1 degrees 2θ ±0.22θ.

46. The crystalline form as claimed in claim 42, wherein the crystalline form exhibits an X- ray powder diffraction pattern substantially as shown in Figure 20.

47. The crystalline form as claimed in any of claims 42 to 45, wherein the crystalline form is a solvate.

48. The crystalline form as claimed in claim 47, wherein the solvate is a tetrahydrofuran solvate.

49. The crystalline form as claimed in any of claims 42 to 48, wherein the compound of formula (I) has a purity of at least 97.5% by mass.

50. A process for producing crystalline form II, IIA, IIB, IIC or IID of a compound of formula (I) as claimed in any of claims 9 to 49, comprising: gradually adding water to a solution of the compound of formula (I) in an organic solvent selected from the group consisting of acetone, isopropanol, methyl ethyl ketone, THF and tert- butanol, producing a solid precipitate, and separating the solid precipitate from the water:organic solvent mixture.

51. The process as claimed in claim 50, wherein the crystalline form is form II, and the organic solvent is acetone.

52. The process as claimed in claim 50 or 51, wherein the water is added to the solution of the compound of formula (I) in organic solvent at a temperature in the range of from 20 to 30°C.

53. The process as claimed in any of claims 50 to 52 wherein, following addition of water, the mixture is cooled to a temperature in the range of from 0 to 5°C.

54. The process as claimed in claim 53, wherein the mixture is cooled over a period in the range of from about 90 minutes to 3 hours, optionally about 2 hours.

55. The process as claimed in any of claims 53 or 54, wherein following cooling, the mixture is maintained at the cooled temperature for a period in the range of from about 90 minutes to 3 hours, optionally about 2 hours.

56. The process as claimed in any of claims 50 to 55, wherein the amount of organic solvent in which the compound of formula (I) is dissolved is in the range of from 2 to 15 volumes, optionally about 10 volumes.

57. The process as claimed in any of claims 50 to 56, wherein the amount of water added to the solution of compound of formula (I) in organic solvent is in the range of from 5 to 40 volumes, optionally about 10 volumes.

58. The process as claimed in any of claims 50 to 57, wherein the solid precipitate is separated from the water:organic solvent mixture by filtration.

59. The process as claimed in any of claims 50 to 58, wherein the separated solid precipitate is washed with water, optionally an amount of water in the range of from 1 to 5 volumes, optionally about 2 volumes of water.

60. A process for producing crystalline form I of a compound of formula (I) as claimed in any of claims 1 to 8, comprising: subjecting the crystalline form II, IIA, IIB, IIC or IID of a compound of formula (I) as claimed in any of claims 9 to 49, to vacuum conditions at a temperature of up to 70°C, thereby producing the crystalline form I.

61. The process as claimed in claim 60, wherein crystalline form II, IIA, IIB, IIC or IID is obtained by carrying out a process as defined in any of claims 50 to 59.

62. The process as claimed in claim 60 or 61, wherein crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions at a temperature in the range of from 30 to 60°C.

63. The process as claimed in any of claims 60 to 62, wherein crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 6 to 120 hours.

64. The process as claimed in claim 63, wherein crystalline form II, IIA, IIB, IIC or IID is subjected to vacuum conditions for a period in the range of from 12 to 18 hours.

65. A pharmaceutical composition comprising crystalline form I of the compound of formula (I) as claimed in any of claims 1 to 8, and a pharmaceutically acceptable excipient.

66. Crystalline form I of the compound of formula (I) as claimed in any of claims 1 to 8, or a pharmaceutical composition comprising the crystalline form, for use in treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns.

67. A method of treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns in a subject, comprising administering an effective amount of crystalline form I of the compound of formula (I) as claimed in any of claims 1 to 8, or an effective amount of a pharmaceutical composition comprising the crystalline form, to the subject.

68. Use of crystalline form I of the compound of formula (I) as claimed in any of claims 1 to 8, for the manufacture of a medicament for treating a wound; promoting wound healing; treating, preventing and / or reducing scarring; preventing or treating a bacterial infection; preventing or treating an inflammatory skin disorder such as psoriasis or eczema; treating an ulcer; and / or treating burns.

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