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

The planned study pairs combination induction treatment with maintenance using OD-001 alone through Week 52.

Rhea-AI Summary

Odyssey Therapeutics (Nasdaq: ODTX) will present its Phase 2a trial design for OD-001 combined with vedolizumab in ulcerative colitis on October 13.

The randomized, double-blind, placebo-controlled study will evaluate efficacy, safety and pharmacokinetics, or how the drug moves through the body, in patients with moderate-to-severe disease. Odyssey expects enrollment of up to 146 patients globally. The design includes a 12-week induction period with the combination, followed by OD-001 alone for maintenance through Week 52. OD-001 targets innate immune activation, while vedolizumab limits immune cell movement into the gut. Odyssey expects topline induction results in the second half of 2027. The poster will be presented at the American College of Gastroenterology annual meeting in Nashville, Tennessee.

Positive

• Minor point. Forward-looking: it has not happened yet and may not happen.Phase 2a combination trial is expected to enroll up to 146 patients globally.
• Minor point. Forward-looking: it has not happened yet and may not happen.Trial plans 12-week combination induction followed by OD-001 monotherapy maintenance through Week 52.
• Minor point. Forward-looking: it has not happened yet and may not happen.Odyssey expects topline induction results in the second half of 2027.

Negative

• None.

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Key Figures

Expected enrollment: Up to 146 patients Induction period: 12 weeks Maintenance period: Through Week 52 +1 more

Expected enrollment

Up to 146 patients

Global Phase 2a trial

Induction period

12 weeks

OD-001 in combination with vedolizumab

Maintenance period

Through Week 52

OD-001 monotherapy following induction

Topline induction results

Second half of 2027

Expected trial results

Key Terms

pharmacokinetics, placebo-controlled, double-blind, ulcerative colitis, +1 more

5 terms

pharmacokinetics medical

"A RIPK2 Scaffolding Inhibitor, in Combination With Vedolizumab"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

placebo-controlled medical

"A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

double-blind medical

"a randomized, double-blind Phase 2a trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

ulcerative colitis medical

"patients with moderate-to-severe ulcerative colitis (UC)"

A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.

ripk2 technical

"OD-001 inhibits upstream RIPK2-mediated innate immune activation"

RIPK2 is an intracellular enzyme that helps immune cells detect threats and trigger inflammation by relaying signals from pattern-recognition receptors to the cell’s response machinery — like a switchboard operator that turns on defensive alarms. It matters to investors because drugs that block or modulate RIPK2 can dampen harmful inflammation in autoimmune diseases and some cancers, making it a potential therapeutic target, biomarker and licensing opportunity in drug development pipelines.

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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.

Contact

Benjamin Navon
Senior Director, Communications

For investors 
investors@odysseytx.com

For media
media@odysseytx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Odyssey Therapeutics expect results from the OD-001 and vedolizumab trial?

Odyssey expects topline induction results in the second half of 2027. The Phase 2a study is designed to evaluate OD-001 combined with vedolizumab during a 12-week induction period in patients with moderate-to-severe ulcerative colitis.

What is the design of Odyssey Therapeutics' OD-001 and vedolizumab Phase 2a trial?

The trial is randomized, double-blind and placebo-controlled, evaluating efficacy, safety and pharmacokinetics in moderate-to-severe ulcerative colitis. Odyssey expects to enroll up to 146 patients globally. Combination treatment during the 12-week induction period will be followed by OD-001 monotherapy maintenance through Week 52.