剂泰科技MTS-004完成三期临床试验，有望填补国内PBA治疗领域药物空白

Core Insights - The company JieTai Technology announced that its AI-driven small molecule formulation optimization platform AiTEM has successfully achieved the primary endpoint of Phase III clinical trials for the candidate drug MTS-004, making it the first AI-enabled formulation new drug to complete Phase III trials in China [1][2] - MTS-004 is the first and currently the only drug in China to complete Phase III clinical trials for Pseudobulbar Affect (PBA), addressing a significant gap in the domestic treatment landscape for PBA [1][3] Company Overview - MTS-004 is a novel oral treatment candidate for PBA, designed as an orally disintegrating tablet (ODT) that dissolves quickly in the mouth without the need for water, improving patient experience and adherence to treatment [1][2] - The AiTEM platform utilizes JieTai's proprietary AI nano-delivery platform NanoForge, employing specialized algorithms for drug formulation design and optimization, significantly reducing the preclinical formulation optimization cycle from the industry average of 1-2 years to just 3 months [2] Clinical Trial Details - The Phase III clinical trial was led by Dr. Fan Dongsheng, a renowned expert in neurodegenerative diseases, and involved a double-blind, randomized, placebo-controlled multi-center study assessing the efficacy and safety of MTS-004 in PBA patients secondary to various neurological conditions [2] - A total of 264 participants were enrolled over a period of 9.5 months, with the trial conducted across 48 clinical centers, including prestigious hospitals such as Peking University Third Hospital and Xuanwu Hospital [2] Efficacy and Safety - MTS-004 demonstrated good overall safety and clear efficacy in treating PBA secondary to neurological diseases, significantly reducing the average frequency of PBA episodes after 12 weeks of treatment, with statistically significant differences observed [3] - The treatment effects were noted as early as the second week, with improvements in emotional control and quality of life measured by various scales, including CNS-LS scores and SF-36 mental health index [3] Future Plans - The company plans to submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for MTS-004 for PBA indications in 2026, with intentions to explore potential expansion into swallowing disorder treatments post-approval [3]