Odyssey Therapeutics reports positive Phase 2a results for oral ulcerative colitis drug OD-001
Odyssey Therapeutics announced that its Phase 2a trial of OD-001 in moderate-to-severe ulcerative colitis met the primary endpoint, showing a mean 2.4‑point reduction in the modified Mayo score after 12 weeks. In the 20 mg twice‑daily cohort, 27% of patients achieved clinical remission and 61% achieved clinical response, with biomarker improvements and no serious safety issues. The company will move the 20 mg dose into a randomized, placebo‑controlled Phase 2b monotherapy trial and a Phase 2a combination study with vedolizumab, with topline data expected in the second half of 2027.
Why it matters
The company says the data support advancing OD-001 to mid‑stage trials, which could eventually create a new revenue stream if the drug gains approval. Investors will watch the upcoming Phase 2b results for further indication of commercial potential.
Key facts
- 1The induction analysis included 56 efficacy‑evaluable patients. stocktitan.net
- 2Mean reduction in modified Mayo score at Week 12 was 2.4 points (p<0.001). sec.gov
- 3In the pooled 20 mg BID group (n=41), clinical remission was 27%, clinical response 61%, and symptomatic remission 49%. stocktitan.net
- 4Biomarker changes in the 20 mg BID group included lower fecal calprotectin, reduced hsCRP and neutrophils, and increased serum albumin. sec.gov
- 5No serious adverse events were reported; three drug‑related events (two fevers, one headache) occurred in the 20 mg BID group. stocktitan.net
- 6Odyssey plans a randomized, placebo‑controlled Phase 2b monotherapy trial and a Phase 2a combination trial with vedolizumab, with topline induction results expected in the second half of 2027. rttnews.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.