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Methods for the treatment of thyroid eye disease

a thyroid eye disease and eye disease technology, applied in the field of thyroid eye disease treatment, can solve the problems of insufficient treatment of ted (tao or go), limited efficacy of medical therapies, and safety concerns, so as to reduce the severity of ted eye disease, improve the quality of life of ted patients, and reduce the effect of proptosis

Inactive Publication Date: 2021-08-19
HORIZON THERAPEUTICS IRELAND DAC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes methods for treating thyroid eye disease (TED) by using an insulin like growth factor-I receptor (IGF 1R) inhibitor. The invention is based on the discovery that this inhibitor can reduce TSHR and IGF-IR display by orbital fibroblasts and fibrocytes, and attenuate the actions of IGF-I, TSH, thyroid-stimulating immunoglobulins, and immunoglobulins isolated from patients with TED. The patent text also describes the results of a clinical trial using teprotumumab, which showed that it can reduce proptosis and improve the quality of life of TED patients. However, the use of teprotumumab is not effective for all patients, so the patent text also discusses the need for alternative therapies for TED.

Problems solved by technology

As described above, TED (TAO or GO) remains inadequately treated.
Prior to the approval of teprotumumab (TEPEZZA™), medical therapies, which primarily consisted of glucocorticoids, had limited efficacy and presented safety concerns.
Previous therapies for the treatment of TED (TAO or GO) had, as stated above, not only limited efficacy, but also safety concerns.

Method used

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  • Methods for the treatment of thyroid eye disease
  • Methods for the treatment of thyroid eye disease
  • Methods for the treatment of thyroid eye disease

Examples

Experimental program
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embodiments

[0021]Embodiment 1. A method of treating thyroid eye disease (TED), comprising administering to the subject an effective amount of an insulin like growth factor-I receptor (IGF-1R) inhibitor.

[0022]Embodiment 2. A method of reducing proptosis by at least 2 mm in a subject with thyroid eye disease (TED), comprising administering to the subject an effective amount of an IGF-IR inhibitor.

[0023]Embodiment 3. The method of Embodiment 2, wherein proptosis is reduced by at least 3 mm.

[0024]Embodiment 4. The method of Embodiment 3, wherein proptosis is reduced by at least 4 mm.

[0025]Embodiment 5. The method of Embodiment 2, wherein the method additionally comprises reducing the clinical activity score (CAS) in the subject with TED.

[0026]Embodiment 6. The method of Embodiment 5, wherein CAS is reduced by at least 2 points.

[0027]Embodiment 7. The method of Embodiment 6, wherein CAS is reduced by at least 3 points.

[0028]Embodiment 8. The method of Embodiment 7, wherein proptosis is reduced by a...

examples

[0413]Exemplary embodiments are provided in the following Examples 1-X. The following examples are presented only by way of illustration and to assist one of ordinary skill in using the invention. The examples are not intended in any way to otherwise limit the scope of the invention. In some embodiments, said IGF-1R inhibitor is an antibody or a subset of antibodies chosen from amongst the Examples below. In some embodiments, said IGF-1R inhibitor is a small molecule or a subset of small molecules chosen from amongst the Examples below.

example a

Teprotumumab

[0414]Provided first is teprotumumab (TEPEZZA), an IGF-1R inhibitor approved for the treatment of TED. Teprotumumab and other related IGF-1R inhibitor antibodies and their methods of preparation can be found in U.S. Pat. No. 7,572,897, US20190225696, and US20190270820, which are hereby incorporated by reference in their entireties. In certain embodiments, teprotumumab may be used as an active control in clinical trials of other IGF-1R inhibitors, e.g. as in Example 31.

TABLE ATeprotumumab Sequences and SEQ ID NumbersSEQIDNODescriptionSequenceAntibody 1(teprotumumab)1CDRH1 aaSer Tyr Gly Met His2CDRH2 aaIle Ile Trp Phe Asp Gly Ser Ser Thr Tyr Tyr Ala Asp Ser Val ArgGly3CDRH3 aaGlu Leu Gly Arg Arg Tyr Phe Asp Leu4CDRL1 aaArg Ala Ser Gln Ser Val Ser Ser Tyr Leu Ala5CDRL2 aaAsp Ala Ser Lys Arg Ala Thr6CDRL3 aaGln Gln Arg Ser Lys Trp Pro Pro Trp Thr7VH aaGln Val Glu Leu Val Glu Ser Gly Gly Gly Val Val Gln Pro GlyArg Ser Gln Arg Leu Ser Cys Ala Ala Ser Gly Phe Thr Phe SerSer Tyr...

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Abstract

Provided herein are methods of treating or reducing the severity of thyroid eye disease (TED), also known as thyroid-associated ophthalmopathy (TAO), or Graves' ophthalmopathy or orbitopathy (GO), as well as antibodies, or antigen binding fragments thereof, and pharmaceutical compositions comprising them, useful in the methods.

Description

[0001]This application is a continuation in part of International Application No. PCT / US2020 / 048350, filed Aug. 28, 2020, which claims the benefit of U.S. Provisional Application No. 62 / 892,849, filed Aug. 28, 2019, the disclosures of which are hereby incorporated by reference as if written herein in their entireties.[0002]Thyroid eye disease (TED), also known as thyroid-associated ophthalmopathy (TAO), Graves' ophthalmopathy or orbitopathy (GO), thyrotoxic exophthalmos, dysthyroid ophthalmopathy, and several other terms, is orbitopathy associated with thyroid dysfunction. TAO is divided into two types. Active TED, which typically lasts 1-3 years, is characterized by an ongoing autoimmune / inflammatory response in the soft tissues of the orbit. Active TED is responsible for the expansion and remodeling of the ocular soft tissues. The autoimmune / inflammatory response of active, or acute, TED spontaneously resolves and the condition transitions into inactive TED. Inactive, or chronic, ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07K16/28A61P27/02
CPCC07K16/2863A61P27/02A61K2039/505C07K2317/56C07K2317/76C07K2317/565A61K39/3955A61K2039/545A61K2039/55A61K31/4985A61K31/365A61K31/5377A61K31/277A61K31/4545A61K31/506A61K31/517A61K31/519A61K31/53
Inventor SHERMAN, JEFFREY W.BENNETT, DENNIS A.RAMANATHAN, SRINIXIN, YANTHOMPSON, ELIZABETHO'NEILL, ELIZABETH
Owner HORIZON THERAPEUTICS IRELAND DAC
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