NeuShen Begins First Human Trial of NS-136 for Schizophrenia Treatment

SHANGHAI and LEXINGTON, Mass., May 8, 2024 — NeuShen Therapeutics, a global biotechnology company specializing in treatments for neurological and psychiatric disorders, has announced the commencement of the Phase I clinical trial of NS-136. This novel compound, a selective M4 receptor positive allosteric modulator (M4 PAM), is being tested in healthy volunteers in Australia.

NS-136 represents an innovative approach to treating schizophrenia, with the potential to improve negative symptoms and cognitive impairments. It also shows promise for treating psychosis associated with Alzheimer's and Parkinson’s diseases. Developed using NeuShen's proprietary small molecule R&D platform, NS-136 has shown significant efficacy against both positive and negative symptoms of schizophrenia in preclinical models, suggesting it could become a leading treatment candidate.

The Phase I trial is a randomized, double-blind, placebo-controlled study aimed at assessing the safety and tolerability of NS-136 in healthy subjects. Positive outcomes from this trial could lead to further clinical trials in patients with schizophrenia and other psychosis-related conditions. NeuShen Therapeutics has also submitted an Investigational New Drug (IND) application to China's National Medical Products Administration (NMPA).

Dr. Joan Shen, founder and CEO of NeuShen Therapeutics, highlighted the company’s expertise and advanced AI technology in the discovery and development of NS-136. Dr. Shen emphasized the potential of NS-136 to offer new therapies not only for schizophrenia but also for a range of cognitive and mood disorders. The rapid initiation of this clinical trial reflects NeuShen's robust R&D capabilities, with the goal of accelerating global development to benefit patients as soon as possible.

Schizophrenia is a debilitating mental disorder marked by repeated episodes of psychosis, requiring prolonged care. It affects over 20 million people globally, presenting positive symptoms like hallucinations and delusions, and negative symptoms such as social withdrawal and cognitive impairment.

Psychotic symptoms are also prevalent in other conditions like Alzheimer's and Parkinson’s diseases, affecting up to 70% of patients in the advanced stages of these illnesses. Currently, there are no effective treatments available for these symptoms.

NeuShen Therapeutics is dedicated to pioneering treatments for neurological and psychiatric disorders. With operations in Shanghai, China, and Lexington, MA, the company boasts a leading R&D team in the central nervous system (CNS) field. They are supported by a highly regarded board of directors and scientific advisory board.

NeuShen Therapeutics continues to focus on innovative drug research and development, aiming to bring new hope to patients with severe mental and neurological conditions.