SOCIUM Inc. and Huaxi Hospital of Sichuan University have decided to conduct an investigator-initiated clinical trial of SO-002, a drug candidate for the treatment of amyotrophic lateral sclerosis (ALS)

SOCIUM Inc. (Head Office: Chuo-ku, Tokyo; President: Katsuhisa Horimoto) and Huaxi Huaxi Hospital of Sichuan University in China (Professor Shang Huifang (Neurology/Rare Diseases)) announce that they have decided to start an investigator-initiated clinical trial for our therapeutic drug candidate SO-002 in patients with amyotrophic lateral sclerosis (ALS). This clinical trial was approved by the Ethics Committee of Huaxi Hospital of Sichuan University on September 12. It will begin immediately after the completion of the contract and other administrative procedures.

Background of Research and Development
ALS is a progressive disease that causes muscle atrophy and weakness due to degeneration of motor neurons (*1).

About the investigational new drug (SO-002)
SOCIUM Inc. has discovered SO-002 (cycloserine), a drug that restores the characteristic gene expression pattern of ALS patients to that of healthy individuals, among drugs already used as therapeutic agents for other diseases, using a proprietary computational analysis platform. Cycloserine (SO-002), which is already used as a therapeutic drug for pulmonary tuberculosis (TB), was confirmed to inhibit the aggregation of abnormal proteins characteristic of ALS patients at extremely low concentrations in a cell line mimicking the pathology of ALS and in ALS patient-derived iPS cell motor neurons. In January 2023, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) granted an exemption from Phase I and approval to start Phase II clinical trials for this drug for ALS.

About Sichuan University Huaxi Hospital
Huaxi Hospital of Sichuan University (founded in 1892) is a national general hospital in China that is positioned as a central facility for the diagnosis and treatment of serious diseases. Huaxi Hospital boasts cutting-edge medical research and is highly ranked in the world rankings of clinical medicine. It has also received the highest rating of A++ in the national evaluation of national public tertiary care institutions for four consecutive years and has been ranked second in the ranking of Chinese hospitals surveyed by Fudan University for 13 consecutive years.

About SOCIUM Inc.
SOCIUM Inc. is a venture company that uses drug repositioning (*2) technology to discover drug seeds. With the vision of ” Drug discovery for patients with no drugs, and those with no effective drugs”, we are working to overcome the unmet medical needs of patients. Owning proprietary AI drug discovery platforms such as Compound-Eyes™, Drug Saver™, and Cyber-Drug-Discovery™, we search for drug seeds based on gene expression pattern analysis without assuming any conventional pharmacological targets. In addition to providing these technical services, we currently have therapeutic seeds for neurodegenerative diseases and cancer resistance improvement.

(*1) Motor neurons
Neurons transmit commands from the brain to skeletal muscles. In ALS patients, these neurons degenerate or die, resulting in the inability to move skeletal muscles.

(*2) Drug repositioning
To discover new applicable indications for existing drugs on the market or drugs in development. Also, to discover existing drugs (known but new chemical structures) that show efficacy against the target disease.

For inquiries regarding this matter, please contact
SOCIUM Inc.
5th, 6th, and 7th floors of Waterfront Center Annex, National Institute of Advanced Industrial Science and Technology (AIST)
2-4-7 Aomi, Koto-ku, Tokyo, Japan 1350064
https://socium.co.jp
E-mail: contact@socium.co.jp