A novel gut-restricted and PHD specific Inhibitor designed and optimised with the support of AI for Inflammatory Bowel Disease (IBD) has shown positive results in two Phase I studies.
Two Phase I studies investigating the safety, tolerability, pharmacokinetics (PK), and food effects (FE) of a drug called ISM5411 were conducted in Australia and China in parallel.
Results from the trials have shown that ISM5411 is generally safe and well tolerated across all dose groups of two Phase I studies, with no reports of serious adverse events or treatment-related adverse events (TRAEs) leading to discontinuation.
The overall occurrence rate of treatment-emergent adverse events (TEAEs) was comparable between all treatment groups and pooled placebo groups in both studies. Most reported TEAEs were Grade 1 and resolved by the end of studies. No clinically significant increases in red blood cell count or haemoglobin were reported.
“I’m pleased to see the good safety and PK profiles of ISM5411, especially the low systemic exposure across all dose groups. These results are suggestive of the gut-restrictive property of ISM5411 and good potential for further clinical development,” said Philip Ryan, principal investigator of the Phase I study in Australia.
As an advanced technology, AI has played important roles in drug discovery and clinical research. We are looking forward to following ISM5411 as it progresses into patient trials, where we hope to see clinical benefits stemming from this technology.”
“These positive Phase I results from the IBD programme are highly encouraging, particularly in validating the gut-restricted pharmacokinetic profile,” said Carol Satler, vice president for clinical development at Insilico Medicine, which has developed the drug,
“Given the limited therapeutic options and the challenges with current IBD treatments, we believe that new therapies will benefit patients in the near future. We look forward to advancing the next phase of validation in patients.”
Based on these results, Insilico Medicine expects to initiate a Phase 2 proof-of-concept study evaluating ISM5411 in active ulcerative colitis patients in the second half of 2025.
