Odyssey reports completed Phase 2a OD-001 induction data at UEG Week 2026

Odyssey Therapeutics announced on October 20, 2026 results from the completed induction period of a Phase 2a trial of OD-001, an oral, selective RIPK2 scaffolding inhibitor being tested in patients with moderate-to-severe ulcerative colitis.¹ The data were presented at United European Gastroenterology Week in Barcelona. The analysis covered all 56 efficacy-evaluable patients.¹

The trial met its primary endpoint of change from baseline in modified Mayo score at Week 12, with a mean reduction of 2.4 points across the evaluable population (p<0.001).¹ At Week 12, clinical remission, clinical response, and symptomatic remission rates were 27%, 61%, and 49% respectively in the pooled 20 mg BID group (n=41), versus 20%, 40%, and 27% in the 10 mg BID group (n=15).¹ Combined with Phase 1 pharmacology data, the company said these findings support 20 mg BID as the projected lowest maximally efficacious dose.¹

On biomarkers, patients on 20 mg BID showed a downward trend in fecal calprotectin, significant decreases in hsCRP and circulating neutrophils, and a significant increase in serum albumin.¹ Exploratory biopsy analysis found reductions in RIPK2-responsive and downstream inflammatory gene signatures, including IL-23, TNF/NF-κB, TL1A, AP-1 and T-cell-associated pathways.¹

On safety, the company reported no serious adverse events, serious infections, treatment-related discontinuations, or liver function abnormalities during the 12-week period. Three drug-related adverse events occurred in the 20 mg BID group, two fevers and one headache.¹ A Grade 3 anemia case arose in the 10 mg BID arm in a patient with pre-existing anemia; it was deemed unrelated to treatment and resolved with iron supplementation, with the patient continuing on OD-001.¹

The open-label, dose-ranging Phase 2a trial (NCT06850727) had no concurrent placebo control, and Odyssey noted the data remain subject to change until database lock.¹ The company intends to move OD-001 into a randomized, placebo-controlled Phase 2b monotherapy study and a separate randomized, active-controlled Phase 2a trial testing OD-001 combined with vedolizumab against vedolizumab plus placebo,¹ with topline induction results expected in the second half of 2027.¹