SHANGHAI and LEXINGTON, Mass. , May 8, 2024 /PRNewswire/ -- 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..

上海和马萨诸塞州列克星敦，2024年5月8日，一家致力于开创神经和精神疾病治疗的临床阶段全球生物技术公司NeuShen Therapeutics（“公司”）今天宣布，澳大利亚第一名健康志愿者将参加NS-136的第一阶段人体临床试验，NS-136是一种新型选择性M4受体阳性变构调节剂（M4 PAM），用于治疗精神分裂症和其他与精神病相关的疾病。。

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..

M4 PAM提供了一种治疗精神分裂症的新方法，在缓解阴性症状和认知障碍方面具有潜在的益处。它也有可能治疗阿尔茨海默病或帕金森病的精神病。NS-136由该公司专有的小分子研发平台开发而成，在临床前动物模型中显示出对精神分裂症阳性和阴性症状的显着疗效，使其成为潜在的同类最佳候选者。。

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.

NS-136的I期临床试验是一项随机，双盲，安慰剂对照研究，旨在评估该化合物在健康受试者中的安全性和耐受性。这项试验的成功结果将为精神分裂症和其他与精神病相关的疾病患者的进一步临床研究铺平道路。

The Company has also submitted an IND application to China's National Medical Products Administration (NMPA) earlier..

该公司早些时候还向中国国家医药产品管理局（NMPA）提交了IND申请。。

'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.

“NS-136是利用我们丰富的中枢神经系统专业知识和先进的人工智能技术在内部发现和开发的。该公司创始人兼首席执行官琼·申（JoanShen）博士说，它不仅有潜力为精神分裂症提供创新疗法，而且还可以为一系列认知和情绪障碍提供创新疗法。

'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.'.

“这项临床试验的快速启动证明了我们强大的研发能力。我们的目标是加速全球发展，并尽快将其提供给我们的患者。”。

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.

精神分裂症是一种严重的精神疾病，其特征是精神病反复发作，需要长期护理。除了幻觉和妄想等积极症状外，精神分裂症患者还会出现消极症状，例如社交退缩，冷漠和认知障碍。

More than 20 million people are estimated to be living with schizophrenia worldwide..

据估计，全世界有2000多万人患有精神分裂症。。

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.

此外，精神病症状也出现在许多其他疾病中，例如阿尔茨海默氏病或帕金森氏病。这些患者中高达70%在疾病晚期出现精神病，目前尚无适当的治疗方法。

About NeuShen Therapeutics

关于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..

NeuShen Therapeutics是一家临床阶段的全球生物技术公司，专注于神经和精神疾病的创新药物研究和开发。该公司在中国上海和马萨诸塞州列克星敦运营，在中枢神经系统领域拥有世界一流的研发团队，并得到了备受尊敬的董事会和科学顾问委员会的建议。。

SOURCE NeuShen Therapeutics

来源NeuShen Therapeutics