Odyssey Therapeutics reports OD-001 Phase 2a ulcerative colitis induction results
Odyssey Therapeutics said the completed induction period of its open-label Phase 2a trial of OD-001 met the primary endpoint, with a mean reduction of 2.4 points in modified Mayo score at Week 12 (p<0.001). The company said the results strengthen the clinical proof of concept and support advancing OD-001 into a placebo-controlled Phase 2b monotherapy trial and a Phase 2a combination trial with vedolizumab. The data are preliminary, come from a trial without a concurrent placebo control, and remain subject to change until database lock.
Key points
- Primary endpoint met: mean reduction of 2.4 points in modified Mayo score from baseline at Week 12 (p<0.001) across 56 evaluable patients.
- Week 12 clinical remission was 27% at 20 mg BID (n=41) and 20% at 10 mg BID (n=15).
- No serious adverse events were reported during the 12-week induction period; three adverse events in the 20 mg BID group were considered drug-related.
- Phase 2b monotherapy and Phase 2a combination trials are planned, with topline induction results expected in the second half of 2027.
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 20, 2026.
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