Odyssey OD-001 Phase 2a UC induction: 27% clinical remission at 20mg BID; primary endpoint met

Odyssey Therapeutics, Inc.

Primary endpoint met: mean 2.4-point reduction in modified Mayo score at Week 12 across 56 efficacy-evaluable patients (p<0.001).
20 mg BID (n=41): clinical remission 27%, clinical response 61%, symptomatic remission 49%; 10 mg BID (n=15): 20%, 40%, 27%.
At 20 mg BID, hsCRP and circulating neutrophils fell significantly and serum albumin rose; remission was 16% in MES 3 patients (n=19) and 29%/23% in therapy-naive/experienced.
No serious adverse events, serious infections, treatment-related discontinuations or liver-function abnormalities; 3 drug-related AEs at 20 mg BID (2 fevers, 1 headache).
Plans randomized placebo-controlled Phase 2b monotherapy and Phase 2a OD-001 plus vedolizumab combo; topline induction data expected H2 2027.

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