Odyssey Therapeutics, Inc. (NASDAQ:ODTX) ("Odyssey" or the "Company"), a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that precisely target disease pathology, today announced that it will present the design of a randomized, double-blind Phase 2a trial evaluating OD-001 in combination with vedolizumab in patients with moderate-to-severe ulcerative colitis (UC) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, taking place October 9-14, in Nashville, Tennessee.

The trial is designed to evaluate a differentiated combination strategy targeting complementary mechanisms of intestinal inflammation: OD-001 inhibits upstream RIPK2-mediated innate immune activation, while vedolizumab limits adaptive immune cell trafficking to the gut. By targeting innate immunity upstream of contemporary therapeutic targets, OD-001 is well positioned as a potential backbone for combination therapy. Building on previously reported Phase 2a proof-of-concept results for OD-001 monotherapy, the trial represents the first clinical evaluation of a combination approach targeting both innate and adaptive immunity in UC.

The trial is expected to enroll up to 146 patients globally and evaluate OD-001 in combination with vedolizumab during a 12-week induction period, followed by maintenance with OD-001 monotherapy through Week 52. Odyssey expects to provide topline induction results from this trial in the second half of 2027.