Insilico Medicine Receives NMPA Approval for Clinical Trial of NLRP3 Inhibitor ISM8969/HT-001 for Parkinson's Disease

Stock News08-03

Insilico Medicine (03696.HK) has announced that its novel oral NLRP3 inhibitor, ISM8969/HT-001, co-developed with Shenzhen 衡泰生物科技有限公司 (Hengtai Biotech), has received clinical trial approval from China's National Medical Products Administration (NMPA) for the treatment of Parkinson's disease.

This approval follows the first human dose administration in the Phase I study in Australia, announced in June 2026, marking the start of parallel clinical evaluations in both China and Australia. The trial aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ISM8969/HT-001 in healthy participants, as well as its preliminary efficacy in patients with Parkinson's disease, laying the foundation for further clinical development.

In preclinical studies, ISM8969/HT-001 demonstrated balanced drug-like properties, including favorable in vitro activity and safety, excellent in vivo PK/PD profiles, and efficacy against inflammation in multiple mouse disease models covering both acute and chronic inflammatory conditions. Compared to other NLRP3 inhibitors that are more advanced in clinical development but have peripheral restrictions, ISM8969/HT-001 can penetrate the blood-brain barrier and enter the central nervous system, making it potentially suitable for treating diseases associated with neuroinflammation.

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The trial aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ISM8969/HT-001 in healthy participants, as well as its preliminary efficacy in patients with Parkinson's disease, laying the foundation for further clinical development.<br><br>In preclinical studies, ISM8969/HT-001 demonstrated balanced drug-like properties, including favorable in vitro activity and safety, excellent in vivo PK/PD profiles, and efficacy against inflammation in multiple mouse disease models covering both acute and chronic inflammatory conditions. 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