СПОСОБ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ

Abstract

Согласно одному варианту осуществления настоящего изобретения, настоящее изобретение относится к фармацевтической композиции, содержащей L-серин или его фармацевтически приемлемую соль, для лечения индивидуума, страдающего заболеванием, выбранным из коммуникативного расстройства, нарушения двигательных функций, когнитивного нарушения, психического расстройства, сенсорного нарушения, расстройства аутистического спектра и общего расстройства психологического развития.

Description

Treatment of diseases The present invention relates to a method for improving or treating a disease or one or more symptoms thereof by administering L-serine to a subject having a disease such as a communication disorder, motor dysfunction, cognitive disorder, mental disorder, sensory disorder, autism spectrum disorder, and pervasive developmental disorder, and to a pharmaceutical composition and its use in the manufacture of a medicament for improving or treating the disease or one or more symptoms thereof. After birth, during the growth process that goes through infancy, childhood, and adolescence, the balanced development of excitatory and inhibitory synapses occurs during the critical stage, which readjusts the cerebral cortex signaling system. During this critical stage, unused synapses are eliminated, and synaptic pruning, which increases the efficiency of frequently used synapses, leads to balanced synaptic development. The timing of synaptic pruning varies by brain region. For example, synaptic pruning in the visual cortex begins at 8 months of age and ends at 6 years of age, while synaptic pruning in the prefrontal cortex begins at 2 years of age and ends at 11 years of age. Meanwhile, if synaptic pruning is not properly performed during the critical period, neurodevelopmental disorders such as communication disorders, motor abnormalities, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders may appear. Symptoms of neurodevelopmental disorders include impaired / deficit social interaction, impaired communication, and / or repetitive behaviors. Furthermore, early intervention must be performed before the end of the critical period to treat or improve the neurodevelopmental disorders. However, because the causes and symptoms of these neurodevelopmental disorders are highly diverse, identifying therapeutic targets or mechanisms is difficult. Furthermore, while risperidone and aripiprazole have been used in limited settings for patients with severe aggression and anxiety, they fail to effectively improve cognitive, social, and language development. Considering this, active research is being conducted on drugs and mechanisms for treating neurodevelopmental disorders. For example, studies have been conducted on drugs such as cholinergic and glutamatergic agents, intranasal oxytocin, and vasopressin-1a receptor antagonists. However, these drugs have not demonstrated significant efficacy compared to placebo in patients with autism spectrum disorder, and currently, there are no approved drugs or regimens for the treatment of social interaction disorders. There is a pressing need for the development of medications and treatments that can improve or treat the primary symptoms of patients with neurodevelopmental disorders, including autism spectrum disorder. In particular, there is a need for medications and treatments that can treat social interaction disorders / deficiencies. [1] One aspect of the present invention relates to a pharmaceutical composition for treating a subject having a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders, the pharmaceutical composition comprising L-serine or a pharmaceutically acceptable salt thereof. [2] In the above [1], the autism spectrum disorder may be childhood autism. [3] In the above [1] or [2], L-serine or a pharmaceutically acceptable salt thereof may be administered to the subject twice a day. [4] In the above [1] to [3], the pharmaceutical composition may be an oral administration formulation. [5] In the above [1] to [4], the pharmaceutical composition may be in the form of a syrup. [6] In the above [1] to [5], the age of the subject may be 18 years or younger. [7] In the above [1] to [6], the age of the subject may be 13 years or younger, 11 years or younger, 7 years or younger, less than 7 years, 2 to 7 years or 2 to 6 years. [8] In the above [1] to [7], the body weight of the object may be 10 kg to 100 kg. [9] In the above [1] to [8], the body weight of the object may be 10 kg to 60 kg.

[0010] In the above [1] to [9], the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 1 g to 60 g.

[0011] In the above [1] to

[0010] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 2 g to 30 g or 2 g to 28 g.

[0012] In the above [1] to

[0010] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 2 g to 15 g or 2 g to 14 g.

[0013] In the above [1] to

[0010] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 4 g to 30 g or 4 g to 28 g.

[0014] In the above [1] to

[0013] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 100 mg / kg to 600 mg / kg.

[0015] In the above

[0014] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 140 mg / kg to 580 mg / kg or 140 mg / kg to 572 mg / kg.

[0016] In the above [1] to

[0013] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 200 mg / kg to 400 mg / kg, 280 mg / kg to 580 mg / kg, or 280 mg / kg to 572 mg / kg.

[0017] In the above [1] to

[0014] , a single dose of the L-serine or a pharmaceutically acceptable salt thereof may be 70 mg / kg to 280 mg / kg, 140 mg / kg to 290 mg / kg, or 140 mg / kg to 286 mg / kg.

[0018] In the above [1] to

[0017] , one or more of a sweetener, a thickener, a pH adjuster, a preservative, and a solvent may be additionally included.

[0019] Another aspect of the present invention relates to a method for treating a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders, comprising administering to a subject having the disease L-serine or a pharmaceutically acceptable salt thereof.

[0020] In the above

[0019] , the autism spectrum disorder may be childhood autism.

[0021] In the above

[0019] or

[0020] , L-serine or a pharmaceutically acceptable salt thereof may be administered to the subject twice a day.

[0022] In the above

[0019] to

[0021] , L-serine or a pharmaceutically acceptable salt thereof can be orally administered to the subject.

[0023] In the above

[0019] to

[0022] , the L-serine or a pharmaceutically acceptable salt thereof can be administered to the subject in the form of a syrup.

[0024] In the above

[0019] to

[0023] , the age of the subject may be 18 years or younger.

[0025] In the above

[0019] to

[0024] , the age of the subject may be 13 years or younger, 11 years or younger, 7 years or younger, less than 7 years, 2 to 7 years or 2 to 6 years.

[0026] In the above

[0019] to

[0025] , the body weight of the object may be 10 kg to 100 kg.

[0027] In the above

[0019] to

[0026] , the body weight of the object may be 10 kg to 60 kg.

[0028] In the above

[0019] to

[0027] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 1 g to 60 g.

[0029] In the above

[0019] to

[0028] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 2 g to 30 g or 2 g to 28 g.

[0030] In the above

[0019] to

[0028] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 2 g to 15 g or 2 g to 14 g.

[0031] In the above

[0019] to

[0028] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 4 g to 30 g or 4 g to 28 g.

[0032] In the above

[0019] to

[0031] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 100 mg / kg to 600 mg / kg.

[0033] In the above

[0032] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 140 mg / kg to 580 mg / kg or 140 mg / kg to 572 mg / kg.

[0034] In the above

[0019] to

[0031] , the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 200 mg / kg to 400 mg / kg, 280 mg / kg to 580 mg / kg, or 280 mg / kg to 572 mg / kg.

[0035] In the above

[0019] to

[0031] , a single dose of the L-serine or a pharmaceutically acceptable salt thereof may be 70 mg / kg to 280 mg / kg, 140 mg / kg to 290 mg / kg, or 140 mg / kg to 286 mg / kg.

[0036] Another aspect of the present invention relates to the use of the pharmaceutical composition of [1] to

[0018] for the manufacture of a medicament for improving, preventing or treating a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders. In one embodiment of the present invention, oral administration of L-serine to a patient with autism spectrum disorder improved the patient's communication, daily living skills, socialization, motor skills, maladaptive behavior, and clinical global impression-severity, and the younger the age at which L-serine administration was initiated (e.g., 7 years or younger or younger than 7 years), the better the effect of improving the patient's communication, daily living skills, socialization, motor skills, maladaptive behavior, and parental stress. Figure 1 is a diagram illustrating an overview of a sociality experiment and a social cognition experiment in an autism spectrum disorder model, and the results of the sociality experiment and social cognition experiment. Figure 1A is a diagram illustrating an overview of a sociality experiment, and Figure 1B is a diagram illustrating an overview of a social cognition experiment. Figures 1C and 1D are diagrams illustrating the results of a sociality experiment. Figures 1E and 1F are diagrams illustrating the results of a social cognition experiment. In Figure 1, * indicates p value <0.05, ** indicates p value <0.01, *** indicates p value <0.001, **** indicates p value <0.0001, and ns indicates statistically insignificant. Figure 2 is a diagram showing the cross maze used in the anxiety experiment in the autism spectrum disorder model and the results of the anxiety experiment. Figure 2A is a schematic diagram of the cross maze used in the anxiety experiment in the autism spectrum disorder model, Figure 2B is a schematic diagram of a heat map tracking the movement of a rat during a behavioral test, and Figures 2C and 2D are diagrams showing the results of the anxiety experiment, respectively. In Figure 2, * indicates p value <0.05, ** indicates p value <0.01, *** indicates p value <0.001, and ns indicates statistically insignificant. Figure 3 is a diagram illustrating the results of an experiment confirming the normalization effect of dopamine secretion in an autism spectrum disorder model using patch clamp. Figure 3A is a diagram illustrating the results of an analysis of the spontaneous action potential firing rate in the midbrain VTA region in the control group and each experimental group, and Figure 3B is a diagram illustrating the results of an analysis of the potential frequency in the control group and each experimental group. In Figure 3, * indicates p value <0.05, and ** indicates p value <0.01. Figure 4 is an experiment confirming the effect of normalizing synaptic pruning in an autism spectrum disorder model. Figure 4A is a diagram observing the entire prelimbic cortex, Figure 4B is a diagram observing the spine density distribution of the dendrites of pyramidal neurons in cortical layer 5 using a confocal microscope system, and Figure 4C is a diagram showing the spine density of the dendrites of pyramidal neurons in cortical layer 5 between groups. ** in Figure 4 indicates p value <0.01, and **** indicates p value <0.0001. Figure 5 is a diagram illustrating the results of an experiment confirming the intrinsic excitability of mPFC pyramidal neurons in an autism spectrum disorder model using patch clamping. Figure 5A is a diagram illustrating the firing rate of action potentials according to current injection, and Figure 5B is a diagram illustrating the change in the firing rate of Figure 5A. ** in Figure 5 indicates a p value <0.01, *** indicates a p value <0.001, and **** indicates a p value <0.0001. Figure 6 is a diagram illustrating the difference in individual recognition according to L-serine dosage in an autism spectrum disorder model. Figure 7 is a diagram illustrating the difference in spatial working memory according to L-serine dosage in an autism spectrum disorder model. Figure 8 is a diagram showing the plasma concentration-time profile in beagle dogs administered L-serine orally or intravenously. Figure 9 is a diagram illustrating an outline of the phase 2 clinical trial. Figure 10 is a diagram showing the trend (line plot) by time point for three groups regarding the change in the Adaptive Behavior Composite (ABC) score of the Korean-Vineland Adaptive Behavior Scale-II (K-VABS-II) at 12, 24, and 36 weeks after the start of the clinical trial compared to the start of the phase 2 clinical trial (FAS group). Figure 11 shows the K-VABS-II ABC and main domains and Korean-Parenting Stress Index-4 (K-Parenting Stress Index-4) at 12 weeks after administration of AST-001 syrup compared to the start of the phase 2 clinical trial. th This is a diagram showing the difference in effect (FAS group) between the treatment group (high-dose group and low-dose group) and the control group (placebo) on the Parental Distress index of the Parental Distress Index (K-PSI-4-SF) in the Forest plot, along with 90% confidence intervals and statistical significance. Figure 12 is a graph analyzing the change in K-VABS-II 2-Domain Composite (mean standard score for two domains of communication and sociality, hereinafter referred to as 2DC) score (FAS group) at 12, 24, and 36 weeks after the start of the clinical trial compared to the start of the phase 2 clinical trial. Figure 13 is a diagram showing the trend (line plot) by time point for the three groups regarding the change in the Clinical Global Impression-Severity (CGI-S) score (FAS group) at 2, 4, 8, 12, 14, 16, 24, and 36 weeks compared to the start of the phase 2 clinical trial. Figure 14 is a diagram analyzing the changes in K-VABS-II ABC (PPS group) at 12, 24, and 36 weeks compared to the start of the phase 2 clinical trial. Figure 15 is a diagram illustrating an outline of a 52-week continuous administration clinical trial. Figure 16 is a diagram showing the trend (line plot) by time point for the CGI-S scores (FAS group) of the two groups from the start of the phase 2 clinical trial to the completion of the 52-week continuous administration clinical trial for patients who participated in the 52-week continuous administration clinical trial. Figure 17 is a diagram showing the trend (line plot) by time point regarding the change in CGI-S scores (FAS group) of the two groups from the start of the phase 2 clinical trial to the completion of the 52-week continuous administration clinical trial for patients who participated in the 52-week continuous administration clinical trial. Figure 18 is a diagram showing the results of prediction of the K-VABS-II ABC score pattern when AST-001 is administered for 12 weeks in a simulation analysis for dosage modeling to be used in a phase 3 clinical trial. L-serine or a pharmaceutically acceptable salt thereof The L-serine used in the present invention is a compound represented by the following chemical formula 1. [Chemical Formula 1] The pharmaceutically acceptable salt of L-serine is a salt commonly used in the pharmaceutical industry, and may be an inorganic salt, an inorganic acid salt, an organic acid salt, a sulfonate salt, etc. of L-serine. Target disease for treatment or symptom improvement In one aspect of the present invention, the target disease for treatment or symptom improvement by administering L-serine or a pharmaceutically acceptable salt thereof may be a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders. Treatment of the above disease may include alleviating symptoms of the disease or preventing the disease. The above communication disorder is a disease that causes problems in communication ability, and can appear in various diseases such as neurological diseases (e.g., brain damage due to trauma), mental disorders (e.g., panic disorder, post-traumatic stress disorder), autism spectrum disorder, and language disorders. The above motor dysfunction refers to problems with the ability to move the body, and can occur in various diseases including neurological diseases, mental disorders, and autism spectrum disorders. The above cognitive impairment refers to a problem in the cognitive ability to recognize surrounding objects, people, and the environment, and can appear in neurological diseases, mental disorders, and autism spectrum disorders. The above mental disorder refers to a psychological health problem that persistently interferes with or limits normal thinking, emotions, behavior, or interpersonal relationships, and can be manifested in depression, bipolar disorder, panic disorder, sadness, schizophrenia, neurosis, obsessive-compulsive disorder, post-traumatic stress disorder, and cognitive impairment. The above sensory impairment is an abnormality in the sense of recognizing external stimuli, and can appear in neurological diseases, mental disorders, and autism spectrum disorders. The above-mentioned pervasive developmental disorder encompasses delays in the normal development of abilities that should occur during the physical and mental development of an individual, such as motor, cognitive, and sensory abilities. The above autism spectrum disorder is known as a neurodevelopmental disorder syndrome accompanied by anxiety as well as core symptoms such as social interaction, and non-limiting examples of autism spectrum disorder include, but are not limited to, autistic disorder, childhood autism, pervasive developmental disorder and Asperger syndrome, Angelman syndrome, Fragile X syndrome, Fragile X-associated tremor / ataxia syndrome (FXTAS), Rett syndrome, Landau-Kleffner syndrome, Prader-Willi syndrome, tardive dyskinesia, and Williams syndrome. Additionally, the individual with the autism spectrum disorder may meet the requirements for autism spectrum disorder in DSM-5 (a diagnosis of autism spectrum disorder defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) and / or ADI-R (Autism Diagnostic Interview-Revised). Pharmaceutical compositions and uses thereof One aspect of the present invention relates to a pharmaceutical composition for treating a subject having a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders, the pharmaceutical composition comprising L-serine or a pharmaceutically acceptable salt thereof. In one embodiment of the present invention, the autism spectrum disorder may be childhood autism. Childhood autism is a disease name classified under the Korean Disease Classification Code F84.0 or the International Classification of Diseases (ICD) F84.0. In another embodiment of the present invention, L-serine or a pharmaceutically acceptable salt thereof may be administered to the subject at least once a day, once a day, twice a day, three times a day, four times a day or five times a day, but preferably twice a day. In another embodiment of the present invention, the pharmaceutical composition may be an intravenous dosage form or an oral dosage form, and preferably an oral dosage form. The pharmaceutical composition of the present invention may be formulated by mixing it with a pharmaceutically acceptable excipient. In one embodiment of the present invention, the pharmaceutical composition may be in the form of a syrup. In another embodiment of the present invention, the subject may be an adult, or the subject may be 1 year old, 2 years old, 3 years old, 4 years old, 5 years old, 6 years old, 7 years old, 8 years old, 9 years old, 10 years old, 11 years old, 12 years old, 13 years old, 14 years old, 15 years old, 16 years old, 17 years old or 18 years old, and preferably less than 18 years old, less than 13 years old, less than 11 years old, less than 7 years old, less than 7 years old, between 2 and 7 years old or between 2 and 6 years old. Additionally, the subject may be a child, 1 year old, 2 years old, 3 years old, 4 years old, 5 years old, 6 years old, 7 years old, 8 years old, 9 years old, 10 years old, 11 years old, 12 years old, 13 years old, 14 years old, 15 years old, 16 years old, 17 years old, or 18 years old, or less than 18 years old, less than 13 years old, less than 11 years old, less than 7 years old, less than 7 years old, between 2 and 7 years old, or between 2 and 6 years old. In another embodiment of the present invention, the body weight of the object may be from 10 to 100 kg, from 10 to 90 kg, from 10 to 80 kg, from 10 to 70 kg or from 10 to 60 kg. In one embodiment of the present invention, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof is 1g, 2g, 3g, 4g, 5g, 6g, 7g, 8g, 9g, 10g, 11g, 12g, 13g, 14g, 15g, 16g, 17g, 18g, 19g, 20g, 21g, 22g, 23g, 24g, 25g, 26g, 27g, 28g, 29g, 30g, 31g, 32g, 33g, 34g, 35g, 36g, 37g, 38g, 39g, 40g, 41g, 42g, 43g, 44g, 45g, 46g, 47g, 48g, 49g, 50g, 51g, 52g, 53g, 54g, 55g, 56g, 57g, 58g, 59g, 60g, 61g, 62g, 63g, 64g, 65g, 66g, 67g, 68g, 69g, 70g, 71g, 72g, 73g, 74g, 75g, 76g, 77g, 78g, 79g, 80g, 81g, 82g, 83g, 84g, 85g, 86g, 87g, 88g, 89g, 90g, 91g, 92g, 93g, 94g, It may be one selected from the group consisting of 95g, 96g, 97g, 98g, 99g and 100g, or may be 1g to 60g, or 2g to 30g, 2g to 28g or 4g to 28g. In addition, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 2g, 4g, 7g, 8g, 10g, 12g 14g, 20g or 28g depending on the body weight of the individual, and the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be the daily dosage depending on the body weight described in Table 4 and Table 15. In another embodiment of the present invention, the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof may be 2 g to 15 g, or 2 g to 14 g, or 4 g to 30 g, or 4 g to 28 g. In another embodiment of the present invention, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 100 mg / kg to 600 mg / kg, 140 mg / kg to 580 mg / kg, 140 mg / kg to 572 mg / kg, 200 mg / kg to 400 mg / kg, 280 mg / kg to 580 mg / kg, or 280 mg / kg to 572 mg / kg. In addition, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 180, 300, 480, or 600 mg / kg. Additionally, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof is about 285.7 to about 400 mg / kg, about 333.3 to about 533.3 mg / kg, about 378.4 to about 560 mg / kg, about 392.2 to about 526.3 mg / kg, about 466.7 to about 538.5 mg / kg, about 142.9 to about 200 mg / kg, about 166.7 to about 266.7 mg / kg, about 189.2 to about 280 mg / kg, about 196.1 to about 263.2 mg / kg, about 233.3 to about 269.2 mg / kg, or about 200 mg / kg to about 400 mg / kg, or about 285 to about 400 mg / kg, about 333 to about 534 mg / kg, about 378 to about 560 mg / kg, about 392 to about 527 mg / kg, about 466 to about 539 mg / kg, about 142 to about 200 mg / kg, about 166 to about 267 mg / kg, about 189 to about 280 mg / kg, about 196 to about 264 mg / kg, about 233 to about 270 mg / kg, about 200 mg / kg to about 400 mg / kg, or about 307.7 to 400 mg / kg, about 400 mg / kg to about 571.4 mg / kg, about 352.9 mg / kg to about 571.4 mg / kg, about 408.2 mg / kg to about 571.It may be 4 mg / kg, about 280 mg / kg, about 311.1 mg / kg, about 350 mg / kg, about 400 mg / kg, about 466.7 mg / kg or about 560 mg / kg, and may be the daily dosage by body weight as described in Table 4 and Table 15. In another embodiment of the present invention, a single dose of the L-serine or a pharmaceutically acceptable salt thereof may be 70 mg / kg to 280 mg / kg, 140 mg / kg to 290 mg / kg, or 140 mg / kg to 286 mg / kg. In addition, a single dose of the L-serine or a pharmaceutically acceptable salt thereof is about 142.9 to about 200 mg / kg, about 166.7 to about 266.7 mg / kg, about 189.2 to about 280 mg / kg, 196.1 to about 263.2 mg / kg, about 233.3 to about 269.2 mg / kg, about 71.4 to about 100 mg / kg, about 83.3 to about 133.3 mg / kg, about 94.6 to about 140 mg / kg, about 98 to about 131.6 mg / kg, or about 116.7 to about 134.6 mg / kg, or about 142 to about 200 mg / kg, about 166 to about 267 mg / kg, about 189 to about 280 mg / kg, about 196 to about 264 mg / kg, about 233 to about 270 mg / kg, about 71 to about 100 mg / kg, about 83 to about 134 mg / kg, about 94 to about 140 mg / kg, about 98 to about 132 mg / kg, about 116 to about 135 mg / kg, about 153.8 to about 200 mg / kg, about 200 to about 285.7 mg / kg, about 176.5 to about 285.7 mg / kg, about 204.1 to about 285.7 mg / kg, about 140 mg / kg, about 155.6 mg / kg, about 175 mg / kg, about 200 mg / kg, about 233.3 mg / kg or about 280 mg / kg, as shown in Table 4 and Table It may be a single dose per body weight as listed in 15. In one embodiment of the present invention, the pharmaceutical composition may further comprise one or more of a sweetener, a thickener, a pH regulator, a preservative, and a solvent. The above sweetener may be any substance used to improve the taste, stability, and mixing properties of a pharmaceutical composition in the technical field to which the present invention pertains, and may include, but is not limited to, sorbitol, maltodextrin, fructose, glycerin, propylene glycol, peanut oil, sorbitan, stevia, and white sugar, and preferably, one or more sweeteners selected from white sugar, sorbitol, acesulfame, and sucralose may be used. The thickener may be any material used to improve the stability and consistency of a pharmaceutical composition in the technical field to which the present invention pertains, and may include, but is not limited to, carboxymethylcellulose (CMC), hydroxypropylmethylcellulose (HPMC), polyvinylpyrrolidone, polyethylene oxide, gum arabic, sorbitol, polysorbate, etc., and preferably, carboxymethylcellulose may be used. The pH adjusting agent may be any substance used to adjust the pH of a pharmaceutical composition in the technical field to which the present invention pertains, and may include, but is not limited to, a basic pH adjusting agent, an acidic pH adjusting agent, a phosphate buffer, sodium bicarbonate, an ammonia solution, sodium chloride, etc., and is preferably an acidic pH adjusting agent, more preferably citric acid (e.g., citric acid hydrate, potassium citrate hydrate) may be used. The above preservative may be any substance used to maintain the stability and preserve the effectiveness of a pharmaceutical composition in the technical field to which the present invention pertains, and may include sodium benzoate, benzyl alcohol, paraben, formaldehyde, etc., and preferably may be methyl paraoxybenzoate and / or propyl paraoxybenzoate. The solvent included in the above pharmaceutical composition is a solvent commonly used in the technical field to which the present invention belongs, and may be purified water, an alcohol solvent, acetone, etc., and preferably purified water. In one embodiment of the present invention, the pharmaceutical composition may include carboxymethylcellulose, citric acid, a sweetener, and purified water, and the sweetener may be a combination of sucrose and sorbitol or a combination of sucralose and acesulfame, and may further include methyl parahydroxybenzoate and / or propyl parahydroxybenzoate. In another embodiment of the present invention, the pharmaceutical composition may include a sweetener, a thickener, a buffer, a solvent, a preservative, and a flavoring agent. The flavoring agent may be any substance used to impart fragrance to the pharmaceutical composition or improve the user experience within the technical field to which the present invention pertains. Examples of such substances include peppermint oil, lemon essential oil, vanilla extract, and fragrance. Another aspect of the present invention relates to the use of the pharmaceutical composition for the manufacture of a medicament for improving, preventing or treating a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders. Treatment methods One aspect of the present invention relates to a method for treating a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders, comprising administering to a subject having the disease L-serine or a pharmaceutically acceptable salt thereof. In one embodiment of the method for treating a disease of the present invention, the autism spectrum disorder may be childhood autism. Childhood autism is a disease classified under the Korean Classification of Diseases code F84.0 or the International Classification of Diseases code F84.0. In another embodiment of the method for treating a disease of the present invention, L-serine or a pharmaceutically acceptable salt thereof may be administered to the subject at least once a day, once a day, twice a day, three times a day, four times a day or five times a day, but preferably twice a day. In another embodiment of the method for treating a disease of the present invention, L-serine or a pharmaceutically acceptable salt thereof may be orally administered to the subject. Furthermore, L-serine or a pharmaceutically acceptable salt thereof may be administered to the subject in a syrup form. Additionally, L-serine or a pharmaceutically acceptable salt thereof may be formulated into the oral administration formulation described above. In one embodiment of the method for treating a disease of the present invention, the subject may be an adult, or the subject may be 1 year old, 2 years old, 3 years old, 4 years old, 5 years old, 6 years old, 7 years old, 8 years old, 9 years old, 10 years old, 11 years old, 12 years old, 13 years old, 14 years old, 15 years old, 16 years old, 17 years old or 18 years old, and preferably may be 18 years old or younger, 13 years old or younger, 11 years old or younger, 7 years old or younger, less than 7 years old, 2 to 7 years old or 2 to 6 years old. Additionally, the subject may be a child, 1 year old, 2 years old, 3 years old, 4 years old, 5 years old, 6 years old, 7 years old, 8 years old, 9 years old, 10 years old, 11 years old, 12 years old, 13 years old, 14 years old, 15 years old, 16 years old, 17 years old, or 18 years old, or less than 18 years old, less than 13 years old, less than 11 years old, less than 7 years old, less than 7 years old, between 2 and 7 years old, or between 2 and 6 years old. In another embodiment of the method for treating a disease of the present invention, the body weight of the subject may be from 10 to 100 kg, from 10 to 90 kg, from 10 to 80 kg, from 10 to 70 kg or from 10 to 60 kg. In one embodiment of the method for treating a disease of the present invention, the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof is 1g, 2g, 3g, 4g, 5g, 6g, 7g, 8g, 9g, 10g, 11g, 12g, 13g, 14g, 15g, 16g, 17g, 18g, 19g, 20g, 21g, 22g, 23g, 24g, 25g, 26g, 27g, 28g, 29g, 30g, 31g, 32g, 33g, 34g, 35g, 36g, 37g, 38g, 39g, 40g, 41g, 42g, 43g, 44g, 45g, 46g, 47g, 48g, 49g, 50g, 51g, 52g, 53g, 54g, 55g, 56g, 57g, 58g, 59g, 60g, 61g, 62g, 63g, 64g, 65g, 66g, 67g, 68g, 69g, 70g, 71g, 72g, 73g, 74g, 75g, 76g, 77g, 78g, 79g, 80g, 81g, 82g, 83g, 84g, 85g, 86g, 87g, 88g, 89g, 90g, 91g, 92g, It can be one selected from the group consisting of 93g, 94g, 95g, 96g, 97g, 98g, 99g and 100g, or can be 1g to 60g, or 2g to 30g, 2g to 28g or 4g to 28g. In addition, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof can be 2g, 4g, 7g, 8g, 10g, 12g, 14g, 20g or 28g depending on the body weight of the individual, and the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof can be the daily dosages listed according to body weight in Table 4 and Table 15. In another embodiment of the method for treating a disease of the present invention, the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof may be 2 g to 15 g, or 2 g to 14 g, or 4 g to 30 g, or 4 g to 28 g. In another embodiment of the method for treating a disease of the present invention, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 100 mg / kg to 600 mg / kg, 140 mg / kg to 580 mg / kg, 140 mg / kg to 572 mg / kg, 140 mg / kg to 580 mg / kg, or 140 mg / kg to 572 mg / kg. Additionally, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof may be 180, 300, 480, or 600 mg / kg. Additionally, the total daily dosage of the L-serine or a pharmaceutically acceptable salt thereof is about 285.7 to about 400 mg / kg, about 333.3 to about 533.3 mg / kg, about 378.4 to about 560 mg / kg, about 392.2 to about 526.3 mg / kg, about 466.7 to about 538.5 mg / kg, about 142.9 to about 200 mg / kg, about 166.7 to about 266.7 mg / kg, about 189.2 to about 280 mg / kg, about 196.1 to about 263.2 mg / kg, about 233.3 to about 269.2 mg / kg, or about 200 mg / kg to about 400 mg / kg, or about 285 to about 400 mg / kg, about 333 to about 534 mg / kg, about 378 to about 560 mg / kg, about 392 to about 527 mg / kg, about 466 to about 539 mg / kg, about 142 to about 200 mg / kg, about 166 to about 267 mg / kg, about 189 to about 280 mg / kg, about 196 to about 264 mg / kg, about 233 to about 270 mg / kg, about 200 mg / kg to about 400 mg / kg, or about 307.7 to 400 mg / kg, about 400 mg / kg to about 571.4 mg / kg, about 352.9 mg / kg to about 571.4 mg / kg, about 408.2 mg / kg to about 571.4 mg / kg, about 280 mg / kg, approximately 311.It may be 1 mg / kg, about 350 mg / kg, about 400 mg / kg, about 466.7 mg / kg or about 560 mg / kg, and may be the daily dose by body weight as listed in Table 4 and Table 15. In one embodiment of the method for treating a disease of the present invention, the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof may be 200 mg / kg to 400 mg / kg, 280 mg / kg to 580 mg / kg, or 280 mg / kg to 572 mg / kg. In another embodiment of the method for treating a disease of the present invention, a single dose of the L-serine or a pharmaceutically acceptable salt thereof may be 70 mg / kg to 280 mg / kg, 140 mg / kg to 290 mg / kg, or 140 mg / kg to 286 mg / kg. In addition, a single dose of the L-serine or a pharmaceutically acceptable salt thereof is about 142.9 to about 200 mg / kg, about 166.7 to about 266.7 mg / kg, about 189.2 to about 280 mg / kg, 196.1 to about 263.2 mg / kg, about 233.3 to about 269.2 mg / kg, about 71.4 to about 100 mg / kg, about 83.3 to about 133.3 mg / kg, about 94.6 to about 140 mg / kg, about 98 to about 131.6 mg / kg, or about 116.7 to about 134.6 mg / kg, or about 142 to about 200 mg / kg, about 166 to about 267 mg / kg, about 189 to about 280 mg / kg, about 196 to about 264 mg / kg, about 233 to about 270 mg / kg, about 71 to about 100 mg / kg, about 83 to about 134 mg / kg, about 94 to about 140 mg / kg, about 98 to about 132 mg / kg, about 116 to about 135 mg / kg, about 153.8 to about 200 mg / kg, about 200 to about 285.7 mg / kg, about 176.5 to about 285.7 mg / kg, about 204.1 to about 285.7 mg / kg, about 140 mg / kg, about 155.6 mg / kg, about 175 mg / kg, about 200 mg / kg, about 233.3 mg / kg or about 280 mg / kg, as shown in Table 4 and Table It may be a single dose per body weight as listed in 15. Hereinafter, the present invention will be described in more detail with reference to the following examples. However, the following examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. Example 1. In vivo autism spectrum disorder animal model experiment Example 1.1. Effects on improving sociality, social awareness, and anxiety Pregnant C57BL / 6 mice were injected subcutaneously with VPA (valproic acid) on day 12 of gestation. Male mice born from pregnant mice that received subcutaneous VPA injection were selected and used as a mouse model of autism spectrum disorder. Since the crystallization period of mice is 3 weeks, 3-week-old normal mice and 3-week-old autism spectrum disorder mice were tested for sociality, social cognition, and anxiety to identify baseline characteristics. 500 mg / kg of L-serine (i.e., AST-001) was orally administered to autism spectrum disorder mice for which baseline characteristics were identified for 2 weeks. The sociability, social cognition, and anxiety tests were then re-administered to autism spectrum disorder mice that had been orally administered AST-001 for 2 weeks. Sociality Experiment A behavioral experiment was conducted to determine whether the experimental mice would move toward the social object by placing a social object (an unfamiliar mouse) and an antisocial object (an empty cage) in both chambers of a three-chamber chamber (see Fig. 1A). From 3 weeks of age, the normal group and the autism spectrum disorder group were orally administered water once a day for 2 weeks, and the drug group was orally administered AST-001 500 mg / kg (dissolved in water) once a day to the autism spectrum disorder mice. 5-week-old normal mice (n=6) and 5-week-old autism spectrum disorder mice (n=6) were used in the experiment. 5-week-old normal mice showed a social preference (preference index) for moving toward the social object, but 5-week-old autism spectrum disorder mice did not show a social preference. However, in a behavioral experiment of a group that was orally administered AST-001 for two weeks, it was confirmed that autism spectrum disorder mice had a social preference for social objects (see Figures 1C and 1D). Specifically, in autism spectrum disorder mice that were not administered AST-001, there was no significant difference in the interaction time with social objects and the interaction time with the empty cage, and this difference was statistically insignificant, indicating a low preference for social objects (see Figures 1C and 1D). On the other hand, in the control group and in autism spectrum disorder mice administered 500 mg / kg of AST-001, the interaction time with social objects was significantly longer than the interaction time with the empty cage, and this difference was statistically significant, indicating a high preference for social objects (see Figures 1C and 1D). Social Cognition Experiment A social recognition test was conducted to measure whether the experimental mice moved toward the unfamiliar mouse when placed between an unfamiliar mouse and a familiar mouse (see Figure 1B). From 3 weeks of age, the normal group and the autism spectrum disorder group were orally administered water once a day for 2 weeks, and the drug group was orally administered 500 mg / kg of AST-001 (dissolved in water) once a day to the autism spectrum disorder mice. 5-week-old normal mice (n=6) and 5-week-old autism spectrum disorder mice (n=6) were used in the experiment. 5-week-old normal mice showed a preference for moving toward the unfamiliar mouse, whereas 5-week-old autism spectrum disorder mice did not show a preference for the unfamiliar mouse. However, in the social recognition test of the group that was orally administered AST-001 for 2 weeks, the autism spectrum disorder mice showed an increased preference for the unfamiliar mouse (see Figures 1E and 1F). Specifically, in autism spectrum disorder mice that were not administered AST-001, there was no significant difference in the interaction time with a familiar mouse and an unfamiliar mouse, and this difference was statistically insignificant, and they showed a low preference for an unfamiliar mouse (see Figures 1E and 1F). On the other hand, in the control group and in autism spectrum disorder mice administered 500 mg / kg of AST-001, the interaction time with an unfamiliar mouse was significantly longer than the interaction time with a familiar mouse, and this difference was statistically significant, and they showed a high preference for an unfamiliar mouse (see Figures 1E and 1F). In other words, oral administration of AST-001 was confirmed to improve the social recognition of autism spectrum disorder mice. Anxiety experiment An anxiety experiment was conducted to determine whether experimental mice exhibited anxious behaviors to avoid open spaces when placed in an elevated plus maze apparatus (see Figure 2A). From 3 weeks of age, the normal and autism spectrum disorder groups were orally administered water once a day for 2 weeks, and the drug group was orally administered 500 mg / kg of AST-001 (dissolved in water) once a day to autism spectrum disorder mice. 5-week-old normal mice (n=6) and 5-week-old autism spectrum disorder mice (n=6) were used in the experiment. 5-week-old autism spectrum disorder mice showed more avoidance of open spaces than 5-week-old normal mice. However, in the anxiety experiment of the group that was orally administered AST-001 for 2 weeks, the anxiety level of the autism spectrum disorder mice decreased and the time spent trying to go to the open space increased (see Figures 2B to 2D). Specifically, autism spectrum disorder mice that were not administered AST-001 spent significantly less time in the open arm of the cross maze and more time in the closed arm of the cross maze (see Figures 2C and 2D). However, the control group and autism spectrum disorder mice administered 500 mg / kg of AST-001 spent significantly longer time in the open arm of the cross maze and spent less time in the closed arm of the cross maze than the autism spectrum disorder mice that were not administered AST-001 (see Figures 2C and 2D). Therefore, it was confirmed that oral administration of AST-001 improved the anxiety level of autism spectrum disorder mice. Example 1.2. Normalizing effect of dopamine secretion An autism spectrum disorder mouse model was created by the method described in Example 1.1. Three-week-old male autism spectrum disorder mice were divided into a group administered 250 mg / kg of AST-001 orally for two weeks (n=6) and a group administered 500 mg / kg of AST-001 orally for two weeks (n=6), and AST-001 was administered orally. The three-week-old male normal mice and autism spectrum disorder mice (n=6) served as a control group (n=6) and were administered water orally once a day for two weeks and used in behavioral experiments. Spontaneous action potentials of dopamine neurons in the midbrain VTA region of 5-week-old normal and 5-week-old male autism spectrum disorder (ASD) mice were observed using patch-clamp imaging. Compared to normal mice, the ASD mice exhibited a reduced firing rate of spontaneous action potentials (see Figure 3A). Therefore, we can conclude that dopamine secretion is reduced in ASD mice, leading to behavioral abnormalities related to dopaminergic pathways, such as attention, reward, and cognition. However, after two weeks of oral administration of AST-001, the spontaneous action potential firing rate of autism spectrum disorder mice was found to be similar to that of normal mice (see Figures 3A and 3B). Therefore, it was confirmed that administration of AST-001 at a dose of 250 mg / kg to 500 mg / kg increases dopamine secretion in autism spectrum disorder mice. Example 1.3. Normalizing synaptic pruning effect A mouse model of autism spectrum disorder was created using the method described in Example 1.1. Since autism spectrum disorder is known to exhibit an excessive increase in dendrites due to errors in synaptic pruning during critical periods, an experiment was conducted to determine whether AST-001 administration could normalize the number of dendrites. For reference, the results of confocal microscopic observations of the prelimbic cortex region are shown in Figure 4A. AST-001 400 mg / kg was administered orally to 3-week-old male autism spectrum disorder mice (n=8) for 2 weeks, and the spine density of synaptic dendritic spines was examined to see if it was similar to that of the control group of male normal mice (n=3). The number of dendritic spines in the autism spectrum disorder mice was significantly reduced, reaching a level similar to that of the control group (see Fig. 4B and Fig. 4C). Therefore, it was confirmed that oral administration of AST-001 normalizes synaptic pruning during the critical period of autism spectrum disorder. Example 1.4. Normalizing neuronal activity BTBR T+tf / J (BTBR), an autism spectrum disorder model animal, and C57BL / 6 mice (used as a control group) were purchased from Jackson Laboratories. When the intrinsic excitability of mPFC pyramidal neurons was measured by the action potential firing rate through current injection using a patch clamp in 3-week-old BTBR mice (n=3) and C57BL / 6 mice (n=3), the action potential firing rate of BTBR mice was reduced compared to the control group (see Fig. 5A). However, when 500 mg / kg of AST-001 was orally administered to BTBR mice for 2 weeks and the action potential firing rate was measured, the action potential firing rates of BTBR mice and the control mice were found to be similar (see Fig. 5B). Example 1.5. Effects of improving object recognition and spatial memory Object recognition experiment Autism spectrum disorder mice were generated using the same method as in Example 1.1. Three-week-old male autism spectrum disorder mice were orally administered 180, 300, 480, or 600 mg / kg / day of L-serine for 21 days, and then subjected to an object recognition test. Eight mice were used in each experimental group. Since mice tend to show more interest in novel objects than familiar ones, we conducted the Novel Object Recognition (NOR) experiment to determine whether they recognize novel objects. As the dose of AST-001 increased, the discrimination index (DI) value for recognizing / memorizing novel objects in autism spectrum disorder mice increased (see Figure 6). Spatial memory experiment Autism spectrum disorder (ASD) mice were generated using the same method as in Example 1.1. Three-week-old male ASD mice were orally administered 180, 300, 480, or 600 mg / kg of L-serine for 28 days, followed by a spatial memory test. Normal mice served as the control group. Eight mice were used in each experimental group. The spatial working memory of mice was evaluated using the Y-maze test. As the L-serine dosage increased, the spontaneous alteration value, a measure of spatial memory, increased (see Figure 7). Example 2. Pharmacokinetic experiment Example 2.1. Pharmacokinetic study in Beagle dogs Beagle dogs (1.8–2.6 years old, 8.6–11.6 kg, n=20) were administered 4 g or 8 g of L-serine orally or intravenously. Blood samples were collected before (basal blood sampling) and after (main blood sampling) L-serine administration. The dogs were fasted throughout the experiment, and plasma L-serine concentrations were analyzed by LC-MS / MS. The plasma concentration-time profiles after oral or intravenous administration of L-serine in beagle dogs are shown in Figure 8. The areas under the plasma concentration-time curve (AUCinf) calculated from the plasma drug concentration curves by time after oral administration of 4 g or 8 g of L-serine were 627.7 ± 108.4 μg·hr / mL and 1329.0 ± 317.8 μg·hr / mL, respectively, and the drug elimination half-life (t½) was calculated to be 3.8 ± 1.4 hours and 4.7 ± 1.8 hours, respectively. The bioavailability by oral administration was 106.5% and 84.2% after administration of 4 g and 8 g per individual, respectively. Example 2.2. Pharmacokinetic study in adult males A pharmacokinetic study was conducted on healthy adult males using the experimental design shown in Table 1. Blood samples were collected 24 hours before administration of AST-001 (the main ingredient L-serine) to measure the concentration of L-serine. 60 g of AST-001 powder is a white, homogeneous powder free of foreign matter, and is subdivided and repackaged in HDPE bottles or bottles of the same material. The composition of this drug contains 1,000 mg of the main ingredient L-serine per 1,000 mg dose. GroupNPeriod 1Wash-outPeriod 218AST-001 Powder 10 g oral single doseNANA28AST-001 Powder 20 g oral single doseNANA38AST-001 Powder 30 g oral single dose7 daysAST-001 Powder 15 g oral single dose once daily, then repeated oral twice daily (total 14 times) Basal L-serine levels 24 hours before AST-001 administration did not show a significant time-dependent change, and no trend was observed according to the time of day. After single oral administration of 10 g, 15 g, 20 g, or 30 g of AST-001, systemic exposure of L-serine (Cmax, AUC) was measured. last and AUCi nf) showed a linear increase as the administered dose of AST-001 increased. Meanwhile, AST-001 reached a steady state when administered orally at 15 g twice a day for 7 days, and the average half-life was approximately 11 hours. Compared to a single 15 g administration of AST-001, it showed an average accumulation index of approximately 1.7 times at steady state. A comprehensive safety evaluation of adverse reactions, clinical laboratory tests, vital signs, electrocardiograms, and physical examinations revealed that AST-001 demonstrated excellent safety and tolerability in healthy adults at single oral doses of up to 30 g per day and repeated oral doses of 15 g twice daily for 7 days. Therefore, AST-001 was confirmed to be safe for administration within the dosage range of 10-30 g per day for indications requiring repeated dosing. The results of pharmacokinetic analysis in a repeat dose trial of AST-001 in healthy adult males are shown in Table 2 below. Tmax: Median, C max, AUC tau, t 1 / 2, CL ss / F, and Vz / F: Mean ± SD Example 2.3. Population Pharmacokinetic Simulation A population pharmacokinetic model of AST-001 was constructed by applying zero-order absorption and first-order elimination to a two-compartment model, and a proportional error model was used as the residual model. Baseline L-serine was reflected in the model by additionally injecting steady-state L-serine. The following pharmacokinetic parameters were reflected in the model by applying allometric scaling to body weight. V1 = V1 × (body weight / 70)1 V2 = V2 × (body weight / 70)1 Q = Q × (body weight / 70)0.75 CL = CL × (body weight / 70)0.75 AUC at steady state after administration of 15 g BID in healthy adults tau (approximately 882.8 h*μg / mL) was set as the target exposure. For population pharmacokinetic simulation analysis, the NONMEM version 7.4 program was used, and the FOCE INTERACTION option was used to analyze blood sampling time and L-serine blood concentration data. In addition, the analysis results showed that baseline L-serine did not generally show a pattern of change over time and was consistently detected in the concentration range of 5-30 μg / mL. The mean AUC of L-serine without baseline correction after single administration of 10 g, 20 g, and 30 g of AST-001 last were 613.3 h* μg / mL, 1134.6 h* μg / mL, and 1525.5 h* μg / mL, respectively, and when 15 g of AST-001 was administered twice a day for 1 week, the mean AUC of L-serine without baseline correction tau was 882.8 h* μg / mL. The average half-life of exogenously administered L-serine using AST-001 was 6.5–14.0 hours. When simulating the dosage regimen by body weight range, the exposure of the proposed dosage regimen of 400 mg / kg and 100 mg / kg was the target AUC. tau The difference was within 30%. Considering the drug exposure observed in clinical trials conducted on healthy adults, it was analyzed that the 4 g / day to 28 g / day AST-001 administration dose in children showed similar effects to the 400 mg / kg / day AST-001 administration dose (see Table 3). Example 3. Phase 2 clinical trial A multicenter, randomized, double-blind, placebo-controlled, therapeutically exploratory Phase 2 clinical trial was conducted to explore the efficacy and safety of AST-001 syrup in 151 children with autism spectrum disorder. The outline of the Phase 2 clinical trial is shown in Figure 9. AST-001 syrup used in the clinical trial is a colorless or light yellow clear syrup with a sweet taste and aroma. It contains 10 g of L-serine as the main ingredient in about 100 mL of this product, and is packaged in aluminum foil in a capacity of 2 g / 20 mL. The composition of AST-001 syrup includes the main ingredient L-serine, the thickener sodium carboxymethylcellulose, the preservatives methyl parahydroxybenzoate, propyl parahydroxybenzoate, the pH adjuster citric acid monohydrate, potassium citrate monohydrate, the sweetener white sugar, D-sorbitol solution, the flavoring apple mint flavor SJ-G (22005221), and purified water. A syrup with the same properties was used as a placebo. AST-001 syrup-placebo does not contain the main ingredient in about 100 mL of this product, and is manufactured with the same composition as the test drug. However, in order to exhibit a similar taste to the test drug, a sweetener (white sugar) was added more than the test drug. Subjects deemed eligible for participation in this clinical trial were randomly assigned to placebo, high-dose, and low-dose groups in a 1:1:1 ratio during the administration period (weeks 0 to 12) of the main study. Patients assigned to the high-dose and low-dose groups were administered AST-001 syrup orally for 12 weeks according to the weight-based dosing regimen and dosages listed in Table 4. For subjects receiving high-dose treatment, the dose corresponding to the low dose was administered for the first two weeks and then increased to the high dose to confirm safety. The control group that had been administered the placebo for the above 12 weeks was administered AST-001 syrup at a high dose as shown in Table 4 during an additional 12-week extension study period (low dose was administered for the first 2 weeks, and then high dose was administered after confirming safety), and the group was classified as the high-dose short-term administration group. Patients who were administered AST-001 syrup at a high dose in the main study continued to receive AST-001 at a high dose and were classified as the high-dose long-term administration group, and patients who were administered AST-001 syrup at a low dose in the main study continued to receive AST-001 syrup at a low dose and were classified as the low-dose long-term administration group. After the end of the 12-week extension study period, the patients' efficacy and adverse reactions were monitored for 12 weeks (i.e., the follow-up period). Baseline characteristics of patients who participated in the clinical trial (FAS group) are presented in Table 5. a: Analysis using Fisher's exact test. effectiveness In the phase 2 clinical trial of AST-001 syrup, the primary efficacy endpoint is the change in the K-VABS-II ABC score from baseline to 12 weeks after administration. The K-VABS-II is a valid and reproducible assessment tool for assessing the functional adaptation level of autism spectrum disorder. It consists of four main domains: communication, life skills, sociality, and motor skills, and an optional maladaptive behavior index domain. Each item consists of a three-point Likert scale (0 points: not at all; 1 point: sometimes or partly; 2 points: usually). The primary endpoint, the K-VABS-II adaptive behavior composite (K-VABS-II ABC) score, is a calculated score (standard score) for the main domains, with a higher score indicating a higher level of adaptive behavior. CGI-S is the OSU (Ohio State University) Autism CGI-S Scale, which evaluates overall severity on a 7-point Likert scale (1 (Normal, not at all ill) to 7 (Among the most extremely ill patients)), with a lower score indicating a lower severity. The changes in the K-VABS-II ABC scores of the three groups at 12, 24, and 36 weeks compared to the start of the clinical trial are shown in Figure 10, and the differences in the effects of the treatment group compared to the control group (placebo) on the K-VABS-II ABC and main domains and K-PSI-4-SF parental distress score at 12 weeks of AST-001 syrup administration are shown in Figure 11, and the changes in the K-VABS-II 2DC scores of the three groups at 12, 24, and 36 weeks compared to the start of the clinical trial are shown in Figure 12. Furthermore, the changes in CGI-S scores of the three groups at 2, 4, 8, 12, 14, 16, 24, and 36 weeks compared to the start of the phase 2 clinical trial are shown in Figure 13. All analyses were conducted on the Full Analysis Set (FAS), which included all patients who received at least one dose of the investigational drug after giving written consent and for whom data on efficacy evaluation variables were collected at least once after baseline. <AST-001 시럽 투여 후 12주 시점 유효성 분석> The change in K-VABS-II ABC score (LS mean±SE) at 12 weeks after administration of AST-001 syrup compared to baseline was 1.66±0.48 points in the control group (placebo) and 3.08±0.49 points in the high-dose group. The change in score in the high-dose group significantly increased compared to the change in the control group (see Figure 11). The difference in change was 1.43±0.69 points [90% Confidence interval (CI): 0.28, 2.58], which was statistically significant (p=0.042) (see Figure 11). Therefore, it was confirmed that the functional adaptation level was improved to a statistically significant level by administering AST-001 syrup. Administration of AST-001 syrup resulted in improvements in the K-VABS-II ABC score, K-VABS-II Communication score, K-VABS-II Daily Living Skills score, K-VABS-II Sociality score, K-VABS-II Motor Skills score, and K-PSI-4-SF parental distress score (see Fig. 11). In particular, the K-VABS-II Communication and Motor Skills domain scores were significantly improved in the high-dose AST-001 syrup group compared to the control group (p value 0.007; p value 0.049, see Fig. 11). In addition, the K-PSI-4-SF parental distress score was significantly improved in the high-dose AST-001 syrup group compared to the control group (p value 0.027, see Fig. 11). Furthermore, when the change in K-VABS-II 2DC score at 12 weeks after the start of the clinical trial was analyzed, the change was higher in the AST-001 syrup low-dose group and the AST-001 syrup high-dose group compared to the control group (see Figure 12), and the change was statistically significant in the high-dose group compared to the control group (p value 0.026). In addition, the baseline mean CGI-S score and the mean CGI-S score at 12 weeks of AST-001 syrup administration, adjusted for age, showed significant improvement compared to the control group in both the high-dose and low-dose groups (see Figure 13). The difference in score changes between the two groups was statistically significant (high-dose group vs. control group p value: 0.046, low-dose group vs. control group p value 0.017). Additionally, a subgroup efficacy analysis was conducted based on the age of the patients participating in the clinical trial, either 7 or 6 years, and the results of the K-VABS-II ABC analysis are as shown in Table 6. As confirmed in Table 6 above, the change in K-VABS-II ABC scores from baseline to 12 weeks in patients aged 7 years or younger and in patients aged 7 years or younger administered high- and low-dose AST-001 syrups was analyzed to be significantly improved compared to the control group. Therefore, the effect of improving autism spectrum disorder was found to be high in the group of patients aged 7 years or younger or in the group of patients aged 7 years or younger, suggesting that early treatment at the critical stage of synaptic pruning is effective in improving the disease. In addition, among the FAS group, a group of patients (PPS) who completed the clinical trial without any serious violations of the clinical trial protocol were selected, and the change in the K-VABS-II ABC score at 12 weeks, which was the primary efficacy endpoint, was analyzed for the PPS group. In the PPS group, the degree of improvement in the high-dose group compared to the control group and the low-dose group compared to the control group was more statistically significant than in the analysis of the FAS group (p value = 0.024; p value = 0.075) (see Figure 14). <AST-001 시럽 투여 후 24주 시점 유효성 분석> The 12- to 24-week extension study period was a period in which AST-001 syrup was administered to all groups, including the high-dose long-term administration group, the low-dose long-term administration group, and the high-dose short-term administration group. All administration groups showed greater improvement at 24 weeks than at the baseline and 12 weeks in terms of changes in K-VABS-II ABC, main domains, 2DC, and CGI-S scores (see Figures 10, 12, and 13). In particular, in the high-dose short-term administration group, which was administered a high dose of AST-001 after 12 weeks of placebo administration, it was confirmed that changes in K-VABS-II ABC, main domains, 2DC, and CGI-S scores significantly improved at 24 weeks compared to 12 weeks. There was no statistically significant difference in the K-VABS-II ABC and CGI-S scores at 24 weeks compared to the baseline among the three groups (p value = 0.555; p value = 0.441). <AST-001 시럽 투여 후 36주 시점 유효성 분석> Meanwhile, the follow-up study period of 24 to 36 weeks after the start of the clinical trial was a period of follow-up observation without administering drugs to patients in all high-dose long-term administration groups, low-dose long-term administration groups, and high-dose short-term administration groups. There was no statistically significant difference in the K-VABS-II ABC and CGI-S scores among the high-dose long-term administration group, low-dose long-term administration group, and high-dose short-term administration group among the three groups (p value = 0.731; p value = 0.611). However, when the effect of drug discontinuation was followed up for 12 weeks (i.e., from weeks 24 to 36) after the end of AST-001 syrup administration, the results of examining the K-VABS-II main domain at the 36-week point showed a tendency for a slight decrease in all main domains except the motor skills main domain, confirming that the efficacy results that had improved up to the 24-week point after administration were the effect of AST-001 syrup. In addition, when the K-VABS-II ABC score change and CSI-S score change at the 36th week of clinical trial initiation were analyzed, the K-VABS-II ABC change and CSI-S score change values ​​were high in the order of AST-001 syrup high-dose long-term administration group, AST-001 syrup low-dose long-term administration group, and AST-001 syrup high-dose short-term administration group, and it was confirmed that the degree of improvement was high in this order (see Figures 10 and 13). As a result, it was confirmed that when AST-001 syrup was orally administered at low or high doses to pediatric patients with autism spectrum disorder, the core symptoms of autism spectrum disorder were improved. Safety Treatment emergent adverse events (TEAEs) that occurred in more than 5% of patients participating in clinical trials are shown in Table 7. During the 36-week clinical trial, the most common adverse reactions were cough, nasopharyngitis, fever, and diarrhea, in that order. Most adverse reactions were mild, and there was no statistically significant difference in adverse reactions between the high-dose group, low-dose group, and control group (p=0.115). Serious adverse reactions not causally related to AST-001 syrup occurred in 5 patients (3.3%). Adverse drug reactions (ADRs) related to AST-001 syrup during the clinical trial were reported in 12 patients (24.0%) in the control group, 6 patients (11.8%) in the low-dose group, and 7 patients (14.0%) in the high-dose group, and there was no statistically significant difference between these groups (p=0.209). In summary, AST-001 syrup administration was shown to be effective in improving symptoms of autism spectrum disorder, such as communication and motor skills, compared to the control group, while also having excellent safety and tolerability. In addition, the high-dose, short-term administration group, which was administered a high dose of AST-001 syrup after 12 weeks of administration to the control group, showed similar developmental levels to the low-dose, long-term administration groups and high-dose, long-term administration groups. Furthermore, the AST-001 syrup administration group showed improvement in parenting stress through improvement in the parental distress subdomain of the K-PSI-4-SF compared to the control group. Therefore, it was confirmed that AST-001 syrup administration can improve core symptoms of autism spectrum disorder and also improve stress in parents caring for patients with autism spectrum disorder. Example 4. 52-week continuous administration clinical trial A Phase 2 clinical trial of Example 3 was completed, and among the 75 subjects who responded to AST-001 syrup, 61 patients willing to participate in a continuous administration trial were selected. Each subject received the drug for up to 52 weeks, and the clinical trial outline is depicted in Figure 15. The above subjects are patients whose K-VABS-II ABC score increased by 4 points or more at 24 weeks (End of Treatment, EOT) compared to baseline in a phase 2 clinical trial, or patients whose global improvement (CGI-Improvement, hereinafter referred to as CGI-I) evaluation result at 24 weeks (EOT) was 1 point (very much improved) or 2 points (much improved). CGI-I is an OSU Autism CGI-I Scale, a 7-point Likert scale (1 point: Very much improved ~ 7 points: Very much worse) that indicates overall improvement compared to the baseline visit of the phase 2 clinical trial, with a lower score indicating a higher degree of improvement. The selected subjects were assigned to one of the administration groups listed in Table 8, and the high-dose AST-001 syrup and low-dose AST-001 syrup dosages are as listed in Table 4. The baseline status of patients at the start of the 52-week continuous administration trial is as described in Table 9 below, and there were no statistically significant differences between the low-dose and high-dose groups in terms of age, gender, proportion of comorbid psychiatric disorders, and baseline CGI-S. effectiveness The mean CGI-S scores and the change from baseline in CGI-S scores measured at baseline (i.e., baseline), weeks 8, 16, 24, 32, 40, and 52 of the 52-week continuous dosing clinical trial are presented in Table 10. Furthermore, the CGI-S scores and the trend of change in CGI-S scores by group from the start of the phase 2 clinical trial to the completion of the 52-week continuous administration clinical trial for patients who participated in the 52-week continuous administration clinical trial are shown in Figures 16 and 17, respectively. Both the low-dose and high-dose groups showed a tendency for CGI-S to improve during the 52-week continuous administration clinical trial, and the level of improvement was higher in the high-dose group than in the low-dose group. Since the CGI-S score (severity) of the low-dose group was higher at the baseline of the continuous administration trial, the low-dose group showed a slightly greater change than the high-dose group until the midpoint. However, the high-dose group showed greater improvement than the low-dose group at the end of the 24-week administration (EOT) of the phase 2 trial, but then worsened until the baseline of the continuous administration trial when administration was discontinued. However, when AST-001 syrup was re-administered, the severity decreased again and was maintained, and additional improvement was shown at the 52-week point. The mean CGI-I scores and CGI-I response rates (proportion of responders with a CGI-I score of 1 or 2) measured at baseline (i.e., baseline), weeks 8, 16, 24, 32, 40, and 52 of the 52-week continuous dosing clinical trial are presented in Table 11 below. At baseline in the 52-week continuous administration trial, the CGI-I score in the low-dose group was lower than that in the high-dose group, but at 52 weeks, the CGI-I score in the high-dose group was lower than that in the low-dose group, indicating that the degree of improvement during the continuous administration trial was greater in the high-dose group than in the low-dose group. In addition, both the low-dose and high-dose groups showed scores in the 2-point range, indicating improvement in the CGI-I evaluation at all time points in the continuous administration trial, demonstrating the improvement effect of long-term administration. In addition, among the 48 subjects who responded to the CGI-I evaluation at the 24-week point in the phase 2 clinical trial, 43 subjects maintained the CGI-I evaluation response at the baseline point in the continuous administration trial, indicating that approximately 90% of subjects maintained the improvement in CGI-I in the phase 2 clinical trial, and approximately 94% of subjects maintained the CGI-I evaluation response until the end of the 52-week continuous administration trial. Furthermore, when the efficacy of AST-001 syrup administration was analyzed by classifying the ages of patients participating in the clinical trial into those aged 8 years or older and those aged 7 years or younger, the group of subjects aged 7 years or younger showed a higher improvement in CGI-S compared to the baseline of the phase 2 clinical trial than the group of subjects aged 8 years or older (see Table 12). Additionally, the improvement in CGI-I at 52 weeks of continuous administration was found to be higher in the group of subjects aged 7 years or younger than in the group of subjects aged 8 years or older (see Table 13). That is, the effect of improving autism spectrum disorder was higher in the patient group of 7 years or younger than in the patient group of 8 years or older in terms of the change in CGI-S score and the mean CGI-I score compared to the baseline in the phase 2 clinical trial, suggesting that early treatment at the critical stage when synaptic pruning occurs is effective in improving the disease. Safety During the 52-week continuous dosing clinical trial, no serious adverse reactions or deaths were reported that were considered related to AST-001. Since the 52-week continuous dosing clinical trial was conducted during the COVID-19 pandemic, COVID-19 was reported as the most common adverse reaction among the 41 TEAEs (5 in the low-dose group and 6 in the high-dose group) (see Table 14 below). Additionally, two adverse drug reactions (ADRs) were Grade 1 (mild) and were confirmed as "recovered" after the adverse reactions. Therefore, the drug appears to be safe for continuous administration for up to 52 weeks without discontinuation in children with autism spectrum disorder. In summary, AST-001 syrup was safe to administer long-term to children with autism spectrum disorder, and its efficacy tended to improve as the period of continuous administration increased. In addition, the therapeutic response seen in the phase 2 clinical trial was generally sustained, and additional improvement effects were confirmed with long-term administration. Example 5. Analysis of Phase 3 Clinical Trial Dosage / Dose Modeling Considering that one packet of AST-001 syrup used in the clinical trial is a 2g / 20mL formulation, modeling analysis was conducted to evaluate whether the effect confirmed in phase 2 clinical trials would be achieved even when the single administration dose for each weight range was set to an even number to increase the convenience of administration for children. For modeling analysis, a population pharmacokinetics / pharmacodynamics model was constructed using the test data obtained from the clinical trial on healthy adult men in Example 2.2 and the phase 2 clinical trial in Example 3. The population pharmacokinetics / pharmacodynamics analysis of AST-001 was performed using the Monolix (version 2021R1) program, and parameter estimation was performed using the stochastic approximation expectation maximization algorithm method using the test time points and KVABS-II-ABC score data according to the clinical trial protocols of Examples 2.2 and 3. A model constructed in Example 2.3 that removed endogenous L-serine production was used as the population pharmacodynamics model. The turnover model, effect compartment model, and direct model were explored for the pharmacodynamic model, and the linear model and Emax model were explored for the drug effect. The time-dependent change in the K-VABS-II-ABC score, including the placebo group, was explored using constant, linear, and exponential models. Using the final pharmacokinetic / pharmacodynamic model, we performed a simulation analysis to predict the K-VABS-II-ABC score pattern when AST-001 was administered for 12 weeks according to various scenarios by body weight group. The Simulx (version 2021R1) program was used for simulation analysis, and data from 1,000 to 1,200 virtual children aged 2 to 12 were generated and analyzed using the 'httk' package of R software. Weight-based dosages 1, 3, and 4 of the simulation scenario were analyzed using data from 1,000 virtual pediatric patients, and weight-based dosage 2 was analyzed using data from 1,200 virtual pediatric patients. The proportion of subjects whose KVABS-II-ABC score increased by 2 or more points at the 12-week point (=target attainment) was explored, and the dose of the scenario that showed target attainment similar to the dosage by weight range administered in the phase 2 clinical trial was expected to be a dose that is convenient to administer and also shows the effect confirmed in the phase 2 clinical trial. [Population Pharmacokinetics / Pharmacodynamics Analysis Results] The pharmacodynamic profile of AST-001 syrup was adequately described by a model in which the drug's effect is linearly proportional to effect site concentration. Changes in K-VABS-II-ABC scores, independent of drug administration, were included in a linear progression model. The final model was analyzed as adequately predicting the pharmacodynamic profile after AST-001 syrup administration through GOF and VPC. [Simulation Analysis Results] When the results of administering AST-001 syrup as a BID regimen for 12 weeks according to various scenarios employed were compared with the simulation results for the dosage regimen by weight range administered in the phase 2 clinical trial, the results of the weight-based dosage 4 scenario reached the efficacy target to the most similar degree, and the analysis results predicting the K-VABS-II-ABC score pattern at 12 weeks at this time are shown in Figure 18. Specifically, in the AST-001 syrup treatment group, the predicted change (median) in the K-VABS-II-ABC score from week 0 to week 12 was 1.67 to 3.74, and in the placebo group, it was predicted to be 0.92 to 1.15 (see Fig. 18). In addition, in the 10 to 13 kg body weight range, when 2 g BID was administered, the proportion of pediatric patients with an increase of 2 or more points in the K-VABS-II-ABC score (target attainment) was 40.5%, which was 2.1 times that of the placebo group, and in other weight ranges, the target attainment rate in the AST-001 syrup treatment group was confirmed to be 1.8 to 2.7 times that of the placebo group (see Fig. 18). Therefore, considering the ease of administration in children and the effectiveness of AST-001 syrup, it was analyzed that AST-001 syrup showed clinically significant efficacy compared to placebo when administered at the dosages according to body weight ranges as shown in Table 15 below.

Claims

1. A pharmaceutical composition for treating an individual having a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders, comprising L-serine or a pharmaceutically acceptable salt thereof.

2. A pharmaceutical composition according to claim 1, wherein the autism spectrum disorder is childhood autism.

3. A pharmaceutical composition according to claim 1 or 2, wherein L-serine or a pharmaceutically acceptable salt thereof is administered to the subject twice a day.

4. A pharmaceutical composition according to any one of claims 1 to 3, which is an oral administration formulation.

5. A pharmaceutical composition in the form of a syrup according to any one of claims 1 to 4.

6. A pharmaceutical composition according to any one of claims 1 to 5, wherein the subject is 18 years of age or younger.

7. A pharmaceutical composition according to any one of claims 1 to 6, wherein the age of the subject is 13 years or younger, 11 years or younger, 7 years or younger, less than 7 years, 2 to 7 years, or 2 to 6 years.

8. A pharmaceutical composition according to any one of claims 1 to 7, wherein the body weight of the subject is 10 to 100 kg.

9. A pharmaceutical composition according to any one of claims 1 to 8, wherein the body weight of the subject is 10 to 60 kg.

10. A pharmaceutical composition according to any one of claims 1 to 9, wherein the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof is 1 g to 60 g.

11. A pharmaceutical composition according to any one of claims 1 to 10, wherein the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof is 2 g to 30 g or 2 g to 28 g.

12. A pharmaceutical composition according to any one of claims 1 to 10, wherein the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof is 2 g to 15 g or 2 g to 14 g.

13. A pharmaceutical composition according to any one of claims 1 to 10, wherein the total daily dosage of L-serine or a pharmaceutically acceptable salt thereof is 4 g to 30 g or 4 g to 28 g.

14. A pharmaceutical composition according to any one of claims 1 to 13, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 100 mg / kg to 600 mg / kg.

15. A pharmaceutical composition according to claim 14, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 140 mg / kg to 580 mg / kg or 140 mg / kg to 572 mg / kg.

16. A pharmaceutical composition according to any one of claims 1 to 13, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 200 mg / kg to 400 mg / kg, 280 mg / kg to 580 mg / kg, or 280 mg / kg to 572 mg / kg.

17. A pharmaceutical composition according to any one of claims 1 to 14, wherein a single dose of L-serine or a pharmaceutically acceptable salt thereof is 70 mg / kg to 280 mg / kg, 140 mg / kg to 290 mg / kg, or 140 mg / kg to 286 mg / kg.

18. A pharmaceutical composition according to any one of claims 1 to 17, further comprising at least one of a sweetener, a thickener, a pH regulator, a preservative, and a solvent.

19. A method for treating a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders, comprising administering L-serine or a pharmaceutically acceptable salt thereof to a subject having the disease.

20. A method for treating a disease according to claim 19, wherein the autism spectrum disorder is childhood autism.

21. A method for treating a disease according to claim 19 or 20, wherein L-serine or a pharmaceutically acceptable salt thereof is administered to the subject twice a day.

22. A method for treating a disease, comprising orally administering L-serine or a pharmaceutically acceptable salt thereof to the subject according to any one of claims 19 to 21.

23. A method for treating a disease according to any one of claims 19 to 22, wherein the L-serine or a pharmaceutically acceptable salt thereof is administered to the subject in the form of a syrup.

24. A method for treating a disease according to any one of claims 19 to 23, wherein the subject is 18 years of age or younger.

25. A method for treating a disease according to any one of claims 19 to 24, wherein the age of the subject is 13 years or younger, 11 years or younger, 7 years or younger, less than 7 years, 2 to 7 years, or 2 to 6 years.

26. A method for treating a disease according to any one of claims 19 to 25, wherein the body weight of the subject is 10 to 100 kg.

27. A method for treating a disease according to any one of claims 19 to 26, wherein the body weight of the subject is 10 to 60 kg.

28. A method for treating a disease according to any one of claims 19 to 27, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 1 g to 60 g.

29. A method for treating a disease according to any one of claims 19 to 28, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 2 g to 30 g or 2 g to 28 g.

30. A method for treating a disease according to any one of claims 19 to 28, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 2 g to 15 g or 2 g to 14 g.

31. A method for treating a disease according to any one of claims 19 to 28, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 4 g to 30 g or 4 g to 28 g.

32. A method for treating a disease according to any one of claims 19 to 31, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 100 mg / kg to 600 mg / kg.

33. A method for treating a disease according to claim 32, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 140 mg / kg to 580 mg / kg, or 140 mg / kg to 572 mg / kg.

34. A method for treating a disease according to any one of claims 19 to 31, wherein the total daily dose of L-serine or a pharmaceutically acceptable salt thereof is 200 mg / kg to 400 mg / kg, 280 mg / kg to 580 mg / kg, or 280 mg / kg to 572 mg / kg.

35. A method for treating a disease according to any one of claims 19 to 31, wherein a single dose of L-serine or a pharmaceutically acceptable salt thereof is 70 mg / kg to 280 mg / kg, 140 mg / kg to 290 mg / kg, or 140 mg / kg to 286 mg / kg.

36. Use of the pharmaceutical composition of any one of claims 1 to 18 for the manufacture of a medicament for improving, preventing or treating a disease selected from communication disorders, motor dysfunction, cognitive disorders, mental disorders, sensory disorders, autism spectrum disorders, and pervasive developmental disorders.

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