Insilico Completes First-in-Human Dosing in Phase I Clinical Study of AI-Driven NLRP3 Inhibitor ISM8969, Achieving First Clinical Milestone in Collaboration with Hygtia Therapeutics

Excerpt from the Press Release:

CAMBRIDGE, Mass. and HONG KONG, June 17, 2026 /PRNewswire/ — Insilico Medicine (“Insilico”, HKEX: 3696), a clinical-stage biotechnology company powered by generative artificial intelligence (AI), today announced it has achieved the first clinical milestone in its co-development collaboration with Hygtia Therapeutics with the completion of first-in-human dosing in the Phase I study of ISM8969. ISM8969 is a potentially best-in-class, orally available, brain-penetrant small-molecule inhibitor of the NLRP3 inflammasome being developed to treat chronic neuroinflammation and central nervous system (CNS) disorders, including Parkinson’s disease.

As the first study in the clinical development of ISM8969, this single-center, Phase I, randomized, double-blind, placebo-controlled trial, including both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered ISM8969 in healthy participants and in obese adult participants at risk of cardiovascular disease. The Phase I study is conducted in Australia and is expected to enroll 80 healthy participants as well as 20 obese adult participants at risk of cardiovascular disease.

In addition, the study will collect cerebrospinal fluid (CSF) samples to assess ISM8969’s penetration into the central nervous system and to characterize its PK/PD profile in the target compartment. The data collected from this study are expected to provide critical evidence to inform dose selection and support therapeutic relevance in future clinical development.

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