Odyssey Therapeutics Reports Positive Phase 2a Results for OD-001

BOSTON, Oct. 20, 2026 /CourierPR/ -- Odyssey Therapeutics, a clinical-stage biopharmaceutical company, has announced promising results from the completed induction period of its Phase 2a clinical trial evaluating OD-001, an oral, selective RIPK2 scaffolding inhibitor, in patients with moderate-to-severe ulcerative colitis. The findings were presented at the United European Gastroenterology (UEG) Week in Barcelona, Spain, and will be discussed further during a conference call and webcast hosted by the company.

The induction analysis, which included all 56 efficacy-evaluable patients, demonstrated a high correlation between treatment outcomes and changes in inflammatory biomarkers, mucosal transcriptomic signatures, and histologic disease activity. These results strengthen the previously established clinical proof of concept for OD-001 and provide biological evidence consistent with RIPK2 scaffolding inhibition. Combined with Phase 1 pharmacology data, these findings support a dosing of 20 mg twice daily (BID) as the projected lowest maximally efficacious dose.

Key highlights from the induction period data include: - Induction (Week 12) efficacy: OD-001 met the trial’s primary endpoint of change from baseline in the modified Mayo score at the end of induction at Week 12 (mean reduction of 2.4 points across the evaluable population; p<0.001). At this time point, clinical remission, clinical response, and symptomatic remission were 27%, 61%, and 49%, respectively, in the pooled 20 mg BID group (n=41) and 20%, 40%, and 27%, respectively, at 10 mg BID (n=15). - Improvement in validated biomarkers of intestinal and systemic inflammation: In patients treated with 20 mg BID, fecal calprotectin trended lower, hsCRP and circulating neutrophils were significantly decreased, and serum albumin significantly increased, all changes consistent with reduced intestinal and systemic inflammation. The reduction in neutrophils, a RIPK2-expressing cell type implicated in IBD pathogenesis, provides additional mechanistic support. - Rapid onset and deepening symptomatic benefit: Symptomatic remission at 20 mg BID reached 21% at Week 2, increasing throughout the induction period with no plateau observed through Week 12. - Comparable efficacy across prior treatment exposure: After 12 weeks of treatment with OD-001, clinical remission at 20 mg BID was 29% in advanced therapy-naïve (n=28) and 23% in advanced therapy-experienced (n=13) patients. - Clinical activity in patients with most severe endoscopic disease: Clinical remission at Week 12 for patients taking OD-001 at 20 mg BID was 16% in patients with a Mayo Endoscopic Score (MES) of 3 (n=19).

Transcriptomic analyses reinforce OD-001 treatment activity by showing on-target activity indicative of RIPK2 inhibition, modulation of fibrosis-associated and epithelial gene signatures, and distinct pharmacology relative to approved mechanisms. These findings support a differentiated mechanism of action and pharmacodynamic profile for OD-001.

Safety and tolerability data from the 12-week induction period indicate that OD-001 was generally well tolerated, with no serious adverse events, serious infections, treatment-related discontinuations, or treatment-emergent liver function abnormalities. Three adverse events in the 20 mg BID group were considered drug-related (two fevers and one headache). One Grade 3 anemia event in the 10 mg BID group occurred in a patient with pre-existing anemia, was considered unrelated to treatment, and resolved with iron supplementation without discontinuing OD-001.

Odyssey plans to advance OD-001 into a randomized, placebo-controlled Phase 2b monotherapy trial and a randomized, active-controlled Phase 2a trial evaluating OD-001 plus vedolizumab versus vedolizumab plus placebo. Both studies will be double-blind, with topline induction results expected in the second half of 2027.

The company will host a conference call and webcast at 8:00 a.m. EDT today to discuss the completed Phase 2a induction results, including additional analyses beyond those presented at UEG.