INSILICO (03696) announced that ISM8969, co-developed with Shenzhen Hengtai Biotechnology Co., Ltd. (Hengtai Biotech), has reached its first clinical milestone with the administration of the first dose in a Phase I study.

As the initial project in the clinical development of ISM8969, this single-center, Phase I, randomized, double-blind, placebo-controlled trial includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Its objective is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral ISM8969 in healthy volunteers and obese adult volunteers with cardiovascular disease risk.

The Phase I study is being conducted in Australia and is expected to enroll 80 healthy volunteers and 20 obese adult volunteers with cardiovascular disease risk.

ISM8969 is an oral, small-molecule NLRP3 inflammasome inhibitor with potential best-in-class characteristics and blood-brain barrier penetration capability. It is intended for the treatment of chronic neuroinflammation and central nervous system (CNS) diseases, including Parkinson's disease.

To accelerate the global development of this drug candidate, INSILICO has entered into an exclusive global strategic co-development partnership with Hengtai Biotech, which is jointly incubated by Shenzhen Pengfu Biomedical Industry Private Equity Investment Fund Partnership (Limited Partnership) and Fosun Pharma.

Under the relevant agreement, INSILICO has granted Hengtai Biotech the rights to research, develop, register, manufacture, and commercialize ISM8969 worldwide, with each party holding a 50% global interest in the project.

Concurrently, INSILICO is eligible to receive upfront and milestone payments totaling up to $66 million.