Odyssey Therapeutics to Present Design of Phase 2a Study Evaluating OD-001 in Combination with Vedolizumab at ACG 2026

Topline induction results expected in the second half of 2027

BOSTON, Oct. 12, 2026 (GLOBE NEWSWIRE) -- 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.

The poster presentation details are as follows:

Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Efficacy, Safety, and Pharmacokinetics of OD-001, a RIPK2 Scaffolding Inhibitor, in Combination With Vedolizumab in Moderate-to-Severe Ulcerative Colitis
Presenter: Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief, Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai
Poster Number: 5698
Date and Time: Tuesday, October 13 from 10:30 a.m. – 4:00 p.m. CDT
Room: Exhibit Halls A-D

About Odyssey Therapeutics
Odyssey Therapeutics is a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that are designed to precisely target disease pathology. Since its founding in 2021, Odyssey has built a portfolio of internally discovered and developed medicines with its first program advancing through multiple clinical milestones. Odyssey’s portfolio leverages the scientific expertise of its team of experienced drug hunters and a comprehensive suite of tools to efficiently advance product candidates that the Company believes have the potential to induce deep and durable remission for patients across several inflammatory diseases with unmet need.

For more information, please visit www.odysseytx.com and follow Odyssey on LinkedIn or X.

Forward-looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding Odyssey’s design, initiation, conduct, and timing of its Phase 2a clinical trial evaluating OD-001 in combination with vedolizumab; the expected enrollment and timing of topline induction results from the trial; the potential safety, efficacy, and therapeutic benefits of OD-001, alone or in combination with existing therapies, including its potential to provide deeper and more durable remission and overcome the therapeutic ceiling in ulcerative colitis and inflammatory bowel disease; the potential benefits of simultaneously targeting innate and adaptive immunity; the therapeutic potential of Odyssey’s product candidates; and Odyssey’s strategy, business plans, or financial performance.

Forward-looking statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “intend,” “goal,” “may,” “plan,” “potential,” “will,” “would” and variations of these words or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are based on Odyssey’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Factors that could cause actual results to differ materially include, but are not limited to, the unpredictable nature of preclinical and clinical development; reliance on third parties; competition; Odyssey’s ability to leverage its team’s scientific expertise and suite of tools to enable more informed drug research and development; intellectual property; legal and regulatory developments; and the other risks and uncertainties described under “Risk Factors” in the Company’s most recently filed Quarterly Report on Form 10-Q and the Company’s other filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Odyssey undertakes no duty to update such information except as required under applicable law.

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Benjamin Navon
Senior Director, Communications

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