secwatch.observer — SEC 8-K summary
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Issuer:     Odyssey Therapeutics, Inc. (ODTX)
CIK:        0001882782
Form:       8-K
Filed at:   2026-10-20T11:00:21+00:00
Accession:  0001193125-26-425684
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1882782/000119312526425684/0001193125-26-425684-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1882782/000119312526425684/odtx-20261020.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-425684

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer