Insilico Medicine, a clinical-stage generative AI-driven drug discovery and development company, on Tuesday announced positive results from studies in Australia and China of ISM5411, a novel gut-restricted and PHD specific Inhibitor designed and optimised with the help of Insilico's Chemistry42 commercially-available generative reinforcement learning platform, for Inflammatory Bowel Disease (IBD).

Two Phase I studies assessing the safety, tolerability, pharmacokinetics (PK) and food effects (FE) of ISM5411 were conducted in Australia and China in parallel. These studies included single ascending dose (SAD), multiple ascending dose (MAD) and FE parts involving 76 healthy subjects in Australia and 48 healthy subjects in China. The company has completed safety and PK data collection for both studies.

The data indicates that ISM5411 was generally safe and well tolerated across all dose groups of the studies, with no reports of serious adverse events or treatment-related adverse events resulting in discontinuation.

Based on these results, Insilico Medicine is planning to commence a Phase 2 proof-of-concept study assessing ISM5411 in active ulcerative colitis subjects in the second half of 2025.