Shanghai, China, and Lexington, MA., - May 8, 2024 - NeuShen Therapeutics (the "Company"), a clinical-stage global biotechnology company dedicated to pioneering treatments for neurological and psychiatric disorders, today announced the dosing of the first healthy volunteer in Australia in the Phase I first-in-human clinical trial of NS-136, a novel selective M4 receptor positive allosteric modulator (M4 PAM) designed for the treatment of schizophrenia and other conditions associated with psychosis.

M4 PAM presents a novel approach to treating schizophrenia, with potential benefits in alleviating negative symptoms and cognitive impairment. It also has the potential to treat psychosis in Alzheimer's disease or Parkinson's disease. NS-136, developed from the Company’s proprietary small molecule R&D platform, has demonstrated significant efficacy against both positive and negative symptoms of schizophrenia in preclinical animal models, positioning it as a potential best-in-class candidate.

The Phase I clinical trial of NS-136 is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of this compound in healthy subjects. Successful results from this trial will pave the way for further clinical studies in patients with schizophrenia and other conditions associated with psychosis. The Company has also submitted an IND application to China’s National Medical Products Administration (NMPA) earlier.

"NS-136 was discovered and developed internally by utilizing our profound CNS expertise and advanced AI technology. It holds great potential to offer innovative therapies for not only schizophrenia but also a spectrum of cognitive and mood disorders," said Dr. Joan Shen, the Company's founder and CEO. "The fast initiation of this clinical trial serves as a testament to our strong R&D capabilities. We aim to accelerate the global development and make it available to our patients as soon as possible."

Schizophrenia is a severe mental disorder characterized by recurring episodes of psychosis that require long-term care. Besides positive symptoms, such as hallucinations and delusions, patients with schizophrenia also experience negative symptoms, such as social withdrawal, apathy, and cognitive impairment. More than 20 million people are estimated to be living with schizophrenia worldwide.

Additionally, psychotic symptoms also appear in many other conditions, such as Alzheimer’s disease or Parkinson’s disease. Up to 70% of these patients experience psychosis in the late stages of their illness, for which there is currently no appropriate treatment available.

About NeuShen Therapeutics

NeuShen Therapeutics is a clinical-stage global biotechnology company focused on innovative drug research and development for neurological and psychiatric disorders. Operating in Shanghai, China, and Lexington, MA, the Company boasts a world-class R&D team in the CNS field and is advised by an esteemed board of directors and scientific advisory board.