China’s generative artificial intelligence (AI)-driven biotech, Insilico Medicine, has announced positive preliminary results from two concluded Phase I studies for its candidate drug ISM5411 in Australia and China. The drug is being developed to treat inflammatory bowel disease (IBD).
Study Details and Results
ISM5411 is an intestinal restriction oral PHD inhibitor. The Phase I studies assessed its safety, tolerability, pharmacokinetics (PK), and food impact in healthy populations. The studies included single dosage escalation and multi-dosage escalation phases, recruiting 76 and 48 healthy subjects in Australia and China, respectively. The results showed that ISM5411 exhibited good safety and tolerability across all dose groups, preliminarily validating its intestinal restrictive pharmacokinetic characteristics.
Future Development
With the positive Phase I readout, ISM5411 is set to advance to a Phase II study in active ulcerative colitis during the second half of 2025. This progression highlights Insilico Medicine’s commitment to leveraging AI-driven drug discovery to address unmet medical needs in inflammatory bowel disease.
Significance of the Results
The positive outcomes from the Phase I studies provide a strong foundation for the further development of ISM5411. This development underscores Insilico Medicine’s innovative approach to drug discovery and its potential to bring effective treatments to patients with inflammatory bowel disease.-Fineline Info & Tech
