OD-001 targets RIPK2 scaffolding, a step in upstream innate immune activation.
Odyssey Therapeutics plans to test the oral inhibitor alongside vedolizumab in a Phase 2a study enrolling up to 146 people worldwide with moderate-to-severe ulcerative colitis. The company expects topline induction results in the second half of 2027.
So far, Odyssey has disclosed the study design, not evidence that the drug pairing works.
Odyssey’s October 2026 announcement identifies NCT06850727 for the OD-001 monotherapy study, while the earlier trial record cited in this article uses OD-07656. The available information does not establish that the two identifiers refer to the same study.
Testing two immune pathways
Vedolizumab, sold as Entyvio, is an approved gut-selective integrin antagonist. It limits adaptive immune cell trafficking to the intestine. Odyssey designed OD-001 to block innate immune activation upstream. The company’s rationale is to inhibit both processes rather than rely on one immune pathway.
The randomized study will use double-blinding and a placebo control. Its 12-week induction period will pair OD-001 with vedolizumab, followed by OD-001 monotherapy through week 52. Odyssey presented the design at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, held October 9-14. This is the company’s first clinical test in UC of combining drugs aimed at innate and adaptive immunity. An October 12 update said enrollment is planned for up to 146 patients and reported no results from the combination study, according to Odyssey’s trial-design update.
Odyssey also announced a conference call and webcast for October 20, 2026, to discuss expanded induction-phase data beyond the material presented at UEG Week.
What the existing data show
The combination study follows an earlier signal-seeking Phase 2a trial of OD-001 alone. In June 2026, Odyssey reported that 27% of the 49 patients who completed 12 weeks achieved clinical remission. Another 61% achieved a clinical response. The company said OD-001 was well tolerated at both doses tested, but released no comparator or placebo data.
Odyssey has scheduled an oral presentation of additional induction-phase efficacy and safety data for October 20 at UEG Week 2026 in Barcelona. The meeting runs October 17-20. Odyssey’s announcement identifies the monotherapy study as NCT06850727 and says the presentation will include data not previously presented, as detailed in the UEG Week presentation announcement.
These are preliminary results reported by the company from a small study. They do not establish that the combination will work. The earlier trial’s ClinicalTrials.gov record uses the code OD-07656. Odyssey’s October announcement gives a different identifier, which alone does not confirm that both records describe the same trial.
The distinction between a planned study and observed outcomes also matters in other disease areas. An earlier trial report described response findings in a different disease. Odyssey has yet to report results for its drug combination.
Other companies are also testing combinations in inflammatory bowel disease. Johnson & Johnson is developing an engineered antibody designed to inhibit IL-23 and TNF-alpha at the same time. In 2026, Phase 2b results for that separate program showed higher clinical remission rates than either biologic alone in Crohn’s disease. Those findings provide context for the approach, but they are not evidence for OD-001.
Odyssey expects topline induction results from its planned study in the second half of 2027.
