Odyssey Therapeutics' OD-001 Meets Phase 2a Endpoint in Ulcerative Colitis, Plans Phase 2b Trial

Odyssey Therapeutics (ODTX) said OD-001, its oral ulcerative colitis treatment, met the primary endpoint of a Phase 2a induction study, showing a statistically significant reduction in the modified Mayo score. Patients achieved an average 2.4-point reduction at Week 12, supporting plans to advance the program into a randomized, placebo-controlled Phase 2b monotherapy trial and a Phase 2a combination study with vedolizumab. In the 56 efficacy-evaluable patients with moderate-to-severe disease, the 20 mg twice-daily dose produced clinical remission, clinical response and symptomatic remission rates of 27%, 61% and 49%, respectively. Symptomatic remission appeared as early as Week 2, and biomarker improvements included lower circulating neutrophils and high-sensitivity C-reactive protein. The 12-week induction period showed no serious adverse events, serious infections, treatment-related discontinuations or liver function abnormalities. The open-label study lacked a placebo arm, and data remain subject to change until final database lock. Topline induction results from both planned studies are expected in the second half of 2027. ODTX closed Tuesday at $18.10, up 5.42%.