ISM8969/HT-001, a blood-brain barrier-penetrating NLRP3 inhibitor jointly developed by Insili Intelligence (03696) and Hengtai Biotech, was approved for clinical trials of new NMPA drugs

According to the Zhitong Finance App, Insi Intelligence (03696) announced that ISM8969/HT-001, an innovative oral NLRP3 inhibitor jointly developed by the company and Shenzhen Hengtai Biotechnology Co., Ltd. (Hengtai Biology), has obtained clinical trial approval for a new drug by the China National Drug Administration (NMPA) to treat Parkinson's disease. Following the announcement of the first human administration in the Australian Phase I study in June 2026, this approval marks the official launch of parallel clinical evaluations in China and Australia.

This clinical trial aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacokinetic (PD) characteristics of ISM8969/HT-001 in healthy participants, as well as its initial efficacy in Parkinson's disease patients, and lay the foundation for its subsequent clinical development.

In preclinical evaluation studies, ISM8969/HT-001 showed balanced pharmacological characteristics, including good in vitro activity and safety, excellent in vivo PK/PD characteristics, and curative effects on inflammation in multiple mouse disease models, covering both acute inflammatory diseases and chronic diseases. Compared with other NLRP3 inhibitors with rapid clinical progression but peripheral restrictions, ISM8969/HT-001 can penetrate the blood-brain barrier and enter the central nervous system, so it is expected to be used to treat diseases related to neuroinflammation.