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EP-4740943-A1 - METHOD FOR TREATING DISEASES

EP4740943A1EP 4740943 A1EP4740943 A1EP 4740943A1EP-4740943-A1

Abstract

In one embodiment of the present invention, the present invention relates to a pharmaceutical composition for treating an individual having a disease selected from communication disorder, abnormal motor ability, cognitive disorder, mental disorder, sensory disturbance, autism spectrum disorder, and pervasive developmental disorder, wherein the pharmaceutical composition comprises L-serine or a pharmaceutically acceptable salt thereof.

Inventors

  • HWANG, Su-Kyeong

Assignees

  • Astrogen, Inc.

Dates

Publication Date
20260513
Application Date
20231212

Claims (20)

  1. A pharmaceutical composition for treating an individual having a disease selected from communication disorder, abnormal motor ability, cognitive disorder, mental disorder, sensory disturbance, autism spectrum disorder, and pervasive developmental disorder, wherein the pharmaceutical composition comprises L-serine or a pharmaceutically acceptable salt thereof.
  2. The pharmaceutical composition according to Claim 1, wherein the autism spectrum disorder is childhood autism.
  3. The pharmaceutical composition according to Claim 1 or 2, wherein the L-serine or the pharmaceutically acceptable salt thereof is administered twice a day to the individual.
  4. The pharmaceutical composition according to any one of Claims 1 to 3, wherein the pharmaceutical composition is a formulation for oral administration.
  5. The pharmaceutical composition according to any one of Claims 1 to 4, wherein the pharmaceutical composition is a syrup formulation.
  6. The pharmaceutical composition according to any one of Claims 1 to 5, wherein the individual is 18 years old or younger.
  7. The pharmaceutical composition according to any one of Claims 1 to 6, wherein the individual is 13 years old or younger, 11 years old or younger, 7 years old or younger, less than 7 years old, 2 years old to 7 years old, or 2 years old to 6 years old.
  8. The pharmaceutical composition according to any one of Claims 1 to 7, wherein a body weight of the individual is 10 to 100 kg.
  9. The pharmaceutical composition according to any one of Claims 1 to 8, wherein a body weight of the individual is 10 to 60 kg.
  10. The pharmaceutical composition according to any one of Claims 1 to 9, wherein a total daily administration dosage of the L-serine or the pharmaceutically acceptable salt thereof is 1 g to 60 g.
  11. The pharmaceutical composition according to any one of Claims 1 to 10, wherein a total daily administration dosage of the L-serine or the pharmaceutically acceptable salt thereof is 2 g to 30 g or 2 g to 28 g.
  12. The pharmaceutical composition according to any one of Claims 1 to 10, wherein a total daily administration dosage of the L-serine or the pharmaceutically acceptable salt thereof is 2 g to 15 g or 2 g to 14 g.
  13. The pharmaceutical composition according to any one of Claims 1 to 10, wherein a total daily administration dosage of the L-serine or the pharmaceutically acceptable salt thereof is 4 g to 30 g or 4 g to 28 g.
  14. The pharmaceutical composition according to any one of Claims 1 to 13, wherein a total daily administration dosage of the L-serine or the pharmaceutically acceptable salt thereof is 100 mg/kg to 600 mg/kg.
  15. The pharmaceutical composition according to Claim 14, wherein a total daily administration dosage of the L-serine or the pharmaceutically acceptable salt thereof is 140 mg/kg to 580 mg/kg or 140 mg/kg to 572 mg/kg.
  16. The pharmaceutical composition according to any one of Claims 1 to 13, wherein a total daily administration dosage of the L-serine or the 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. The pharmaceutical composition according to any one of Claims 1 to 14, wherein a single administration dosage of the L-serine or the 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. The pharmaceutical composition according to any one of Claims 1 to 17, further comprising one or more among a sweetener, a thickener, a pH adjusting agent, a preservative, and a solvent.
  19. A method for treating a disease selected from communication disorder, abnormal motor ability, cognitive disorder, mental disorder, sensory disturbance, autism spectrum disorder, and pervasive developmental disorder, wherein the method comprises a step of administering L-serine or a pharmaceutically acceptable salt thereof to an individual having the disease.
  20. The method for treating a disease according to Claim 19, wherein the autism spectrum disorder is childhood autism.

Description

Technical Field The present invention relates to a method for administering L-serine to an individual having a disease such as communication disorder, abnormal motor ability, cognitive disorder, mental disorder, sensory disturbance, autism spectrum disorder, and pervasive developmental disorder, thereby improving or treating the disease or one or more of symptoms of the disease, and a pharmaceutical composition for improving or treating the disease or one or more of symptoms of the disease, as well as uses of these for manufacturing a medicament. Background Art In the process of growth of a child, after birth through the infant, child, and adolescent stages, the development of excitatory synapses/inhibitory synapses is achieved in a balanced manner at the critical stage of rebalancing the cerebral cortex signaling system. The balanced development of synapses is achieved through synaptic pruning by which unused synapses are removed during the critical stage, and the efficiency of frequently used synapses is increased. The initiation time and end time of synaptic pruning vary between brain regions. For example, synaptic pruning in the visual cortex begins at 8 months after birth and ends at age 6, and synaptic pruning in the prefrontal cortex begins at age 2 and ends at age 11. On the other hand, in a case where synaptic pruning is not achieved properly at the critical stage, neurodevelopmental disorders, such as communication disorder, abnormal motor ability, cognitive disorder, mental disorder, sensory disturbance, autism spectrum disorder, and pervasive developmental disorder, may occur. Disorders/deficiencies in reciprocal social interaction, communication disorder, and/or repetitive behavior, and the like are known as symptoms of neurodevelopmental disorders. In addition, for the treatment or amelioration of neurodevelopmental disorders, early intervention should be made before the end of the critical stage. However, the causes and symptoms of the above-described neurodevelopmental disorder are very diverse, and thus it is difficult to find a target substance or therapeutic mechanism. In addition, although risperidone and aripiprazole have been used to a limited extent in a patient with severe aggression and severe anxiety, there is a problem in that cognitive development, social development, and language development cannot be effectively improved. In consideration of this, research on drugs/mechanisms for treating neurodevelopmental disorders is being actively carried out. For example, research has been carried out on drugs such as cholinergic and glutamic substances, oxytocin administered intranasally, and a vasopressin 1a receptor inhibitor as drugs for treating neurodevelopmental disorders. However, these drugs have not shown significant effects as compared with placebos in patients with autism spectrum disorder, and there are currently no approved drugs and usage that make it possible to treat reciprocal social interaction disorder/deficiency. Disclosure of Invention Technical Problem There is a demand for the development of drugs and therapeutic usage that make it possible to ameliorate or treat the main symptoms of patients with neurodevelopmental disorders, including autism spectrum disorder. In particular, there is a need for the development of drugs and therapeutic usage that make it possible to treat reciprocal social interaction disorder/deficiency. Solution to Problem [1] One aspect of the present invention relates to a pharmaceutical composition for treating an individual having a disease selected from communication disorder, abnormal motor ability, cognitive disorder, mental disorder, sensory disturbance, autism spectrum disorder, and pervasive developmental disorder, wherein the pharmaceutical composition comprises L-serine or a pharmaceutically acceptable salt thereof.[2] In [1] described above, the autism spectrum disorder may be childhood autism.[3] In [1] or [2] described above, the L-serine or the pharmaceutically acceptable salt thereof may be administered twice a day to the individual.[4] In any one of [1] to [3] described above, the pharmaceutical composition may be a formulation for oral administration.[5] In any one of [1] to [4] described above, the pharmaceutical composition may be a syrup formulation.[6] In any one of [1] to [5] described above, the individual may be 18 years old or younger.[7] In any one of [1] to [6] described above, the individual may be 13 years old or younger, 11 years old or younger, 7 years old or younger, less than 7 years old, 2 years old to 7 years old, or 2 years old to 6 years old..[8] In any one of [1] to [7] described above, a body weight of the individual may be 10 to 100 kg.[9] In any one of [1] to [8] described above, a body weight of the individual may be 10 to 60 kg.[10] In any one of [1] to [9] described above, a total daily administration dosage of the L-serine or the pharmaceutically acceptable salt thereof may be 1 g to 60 g.[11] In any