Odyssey Therapeutics Presents Completed Phase 2a OD-001 Induction Results Strengthening Clinical Proof of Concept at UEG Week 2026

The open-label findings precede planned controlled trials, with topline induction results expected in the second half of 2027.

Rhea-AI Summary

Odyssey Therapeutics (ODTX) reported completed Phase 2a induction results for OD-001 in moderate-to-severe ulcerative colitis, meeting the primary endpoint. Across 56 efficacy-evaluable patients, the modified Mayo disease-activity score fell by a mean 2.4 points at Week 12 (p<0.001). Clinical remission, clinical response and symptomatic remission were 27%, 61% and 49% with 20 mg twice daily, versus 20%, 40% and 27% with 10 mg twice daily.

Biomarker and exploratory gene-expression findings aligned with clinical activity. No serious adverse events occurred; three events were considered drug-related. The trial was open-label without a concurrent placebo control, and data remain subject to change until database lock. Odyssey plans double-blind Phase 2b monotherapy and Phase 2a combination trials, with topline induction results expected in the second half of 2027.

14 points · 1 major

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0 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointPrimary endpoint met: mean modified Mayo score reduction of 2.4 points at Week 12; p<0.001.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Planned double-blind trials: Phase 2b monotherapy and Phase 2a combination, with topline induction results expected second-half 2027.
• Minor point20 mg twice daily: Week 12 clinical remission 27%, clinical response 61%, symptomatic remission 49% (n=41).
• Minor point10 mg twice daily: Week 12 clinical remission 20%, clinical response 40%, symptomatic remission 27% (n=15).
• Minor pointSymptomatic remission at 20 mg twice daily reached 21% at Week 2, increasing without plateau through Week 12.

9 minor points

• Minor pointWeek 12 clinical remission at 20 mg twice daily: 29% in advanced therapy-naïve versus 23% in experienced patients.
• Minor pointSevere endoscopic disease: Week 12 clinical remission reached 16% at 20 mg twice daily (n=19).
• Minor point20 mg twice-daily biomarkers: hsCRP and circulating neutrophils significantly decreased; serum albumin significantly increased.
• Minor pointFecal calprotectin, a marker of intestinal inflammation, trended lower with 20 mg twice daily.
• Minor pointExploratory biopsy analyses showed reduced RIPK2-responsive and downstream inflammatory gene signatures.
• Minor pointFibrosis-associated gene signatures decreased; genes linked to epithelial homeostasis and mucosal healing increased, aligning with clinical outcomes.
• Minor pointExploratory comparisons with published therapy datasets suggested effects on RIPK2-associated pathways beyond general mucosal improvement.
• Minor point12-week safety: no serious adverse events, serious infections, treatment-related discontinuations or treatment-emergent liver function abnormalities.
• Minor point. Forward-looking: it has not happened yet and may not happen.20 mg twice daily is the company's projected lowest maximally efficacious dose, supported by induction and Phase 1 data.

Negative

• Moderate pointOpen-label trial without concurrent placebo control limits interpretation of the efficacy findings.
• Minor pointInduction data remain subject to change until database lock.
• Minor pointThree drug-related adverse events occurred at 20 mg twice daily: two fevers and one headache.
• Minor pointOne Grade 3 anemia event at 10 mg twice daily was considered unrelated and resolved without treatment discontinuation.

Key Figures

Modified Mayo score reduction: 2.4 points; p<0.001 Clinical remission: 27% (20 mg BID); 20% (10 mg BID) Clinical response: 61% (20 mg BID); 40% (10 mg BID) +4 more

Modified Mayo score reduction

2.4 points; p<0.001

Week 12 primary endpoint; mean reduction across efficacy-evaluable patients

Clinical remission

27% (20 mg BID); 20% (10 mg BID)

Week 12; n=41 and n=15, respectively

Clinical response

61% (20 mg BID); 40% (10 mg BID)

Week 12; n=41 and n=15, respectively

Symptomatic remission

49% (20 mg BID); 27% (10 mg BID)

Week 12; n=41 and n=15, respectively

Efficacy-evaluable patients

56 patients

Completed Phase 2a induction analysis

Week 2 symptomatic remission

21%

20 mg BID group

Expected topline induction results

Second half of 2027

Planned Phase 2b monotherapy and Phase 2a combination studies

Previous Clinical trial Reports

1 past event · Latest: Oct 12

Same Type 1 event

1. Oct 12

   Combination trial design

   24h Move

   -3.9%

   Outlined enrollment and induction/maintenance design for the OD-001–vedolizumab combination study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

modified mayo score, open-label, bid

3 terms

modified mayo score medical

"change from baseline in modified Mayo score at the end of induction"

A modified Mayo score is a simplified clinical measure used to gauge severity and improvement in ulcerative colitis by combining patient symptoms and a clinician’s assessment, typically leaving out the full endoscopic exam. For investors, it matters because changes in this score are often used as a trial endpoint to show a treatment’s benefit; clearer, faster improvements can speed regulatory decisions, affect drug valuation, and influence market confidence. An everyday analogy: it’s like a shorter vehicle inspection that focuses on visible problems rather than a full engine tear-down.

open-label medical

"using an open-label, dose-ranging design"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

bid medical

"20 mg twice daily (BID) as the projected lowest maximally efficacious dose"

A bid is the price a buyer is willing to pay for a share or other security at a given moment. It signals demand and helps set the market price — the gap between buyers’ bids and sellers’ asking prices shows how easy or costly it is to trade, much like a shopper offering a price at a flea market and comparing it to the seller’s sticker. Investors watch bids to gauge interest, execution likelihood, and short-term price direction.

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Correlation between clinical efficacy and changes in inflammatory biomarkers, mucosal transcriptomic signatures, and histologic disease activity strengthens the previously shown clinical proof of concept for OD-001 

Favorable tolerability profile and oral administration underscore the potential of OD-001 as a monotherapy and backbone for combination regimens in inflammatory bowel disease

Company to host conference call and webcast at 8:00 a.m. EDT

BOSTON, Oct. 20, 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 results from the completed induction period of its Phase 2a clinical trial evaluating OD-001, an oral, selective RIPK2 scaffolding inhibitor, in patients with moderate-to-severe ulcerative colitis (UC). The results were presented earlier today at United European Gastroenterology (UEG) Week in Barcelona, Spain, and will be discussed alongside additional analyses during a conference call and webcast to be hosted by Odyssey.

The completed OD-001 induction analysis comprises all 56 efficacy-evaluable patients. The high correlation between treatment outcomes and changes in inflammatory biomarkers, mucosal transcriptomic signatures, and histologic disease activity strengthens the previously established clinical proof of concept for OD-001 and provides biological evidence consistent with RIPK2 scaffolding inhibition. Combined with Phase 1 pharmacology data, these findings support 20 mg twice daily (BID) as the projected lowest maximally efficacious dose.

“These new analyses provide compelling evidence of pharmacologic activity at 20 mg BID, including clinical efficacy in patients with severe endoscopic disease and improvements across markers of intestinal and systemic inflammation,” said Gary D. Glick, Ph.D., founder and chief executive officer of Odyssey Therapeutics. “Transcriptomic findings that align with clinical activity and are consistent with RIPK2 scaffolding inhibition reinforce the mechanistic rationale for this approach in inflammatory bowel disease, strengthen our confidence in the treatment activity of OD-001, and support its continued clinical development.”

Key highlights from the induction period data

• Induction (Week 12) efficacy: OD-001 met the trial’s primary endpoint of change from baseline in modified Mayo score at the end of induction at Week 12 (mean reduction of 2.4 points across the evaluable population; p<0.001). At this time point, clinical remission, clinical response, and symptomatic remission were 27%, 61%, and 49%, respectively, in the pooled 20 mg BID group (n=41) and 20%, 40%, and 27%, respectively, at 10 mg BID (n=15).
• Improvement in validated biomarkers of intestinal and systemic inflammation: In patients treated with 20 mg BID, fecal calprotectin trended lower, hsCRP and circulating neutrophils were significantly decreased, and serum albumin significantly increased—all changes consistent with reduced intestinal and systemic inflammation. The reduction in neutrophils, a RIPK2-expressing cell type implicated in IBD pathogenesis, provides additional mechanistic support.
• Rapid onset and deepening symptomatic benefit: Symptomatic remission at 20 mg BID reached 21% at Week 2, increasing throughout the induction period with no plateau observed through Week 12.
• Comparable efficacy across prior treatment exposure: After 12 weeks of treatment with OD-001, clinical remission at 20 mg BID was 29% in advanced therapy-naïve (n=28) and 23% in advanced therapy-experienced (n=13) patients.
• Clinical activity in patients with most severe endoscopic disease: Clinical remission at Week 12 for patients taking OD-001 at 20 mg BID was 16% in patients with a Mayo Endoscopic Score (MES) of 3 (n=19).
  
  

Transcriptomic analyses reinforce OD-001 treatment activity

• On-target activity indicative of RIPK2 inhibition: Exploratory analyses of paired colonic biopsies from baseline and Week 12 showed reductions in RIPK2-responsive and downstream inflammatory gene signatures, including IL-23, TNF/NF-κB, TL1A, AP-1 and T-cell-associated pathways, supporting the proposed mechanism of action.
• Modulation of fibrosis-associated and epithelial gene signatures: Reductions in fibrosis-associated signatures and increased expression of genes linked to epithelial homeostasis and mucosal healing aligned with clinical outcomes.
• Distinct pharmacology relative to approved mechanisms: Exploratory patient-level comparisons with published datasets of approved therapies suggest OD-001 modulates RIPK2-associated pathways beyond general mucosal improvement achieved with other agents, supporting a differentiated mechanism of action and pharmacodynamic profile.
  
  

Safety and tolerability

OD-001 was generally well tolerated during the 12-week induction period, with no serious adverse events, serious infections, treatment-related discontinuations, or treatment-emergent liver function abnormalities. As previously reported, three adverse events in the 20 mg BID group were considered drug-related (two fevers and one headache). One Grade 3 anemia event in the 10 mg BID group occurred in a patient with pre-existing anemia, was considered unrelated to treatment, and resolved with iron supplementation without discontinuing OD-001.

Phase 2a clinical trial overview

The Phase 2a trial (NCT06850727) evaluated the efficacy, safety and tolerability of oral OD-001 in patients with moderate-to-severe ulcerative colitis using an open-label, dose-ranging design. The 12-week induction period included 10 mg and 20 mg BID dosing, with change from baseline in the three-component modified Mayo score as the primary endpoint. This open-label trial had no concurrent placebo control, and the data remain subject to change until database lock.

OD-001 advancing into Phase 2b monotherapy and Phase 2a combination trials

Odyssey plans to advance OD-001 into a randomized, placebo-controlled Phase 2b monotherapy trial and a randomized, active-controlled Phase 2a trial evaluating OD-001 plus vedolizumab versus vedolizumab plus placebo. Both studies will be double-blind, with topline induction results expected in the second half of 2027.

Conference call and webcast

Odyssey will host a conference call and webcast today at 8:00 a.m. EDT to discuss the completed Phase 2a induction results, including additional analyses beyond those presented at UEG. The live webcast and accompanying presentation will be available through the Investors section of Odyssey Therapeutics’ website at www.odysseytx.com. A replay will be available following the event.

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 http://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 the interpretation and potential implications of OD-001’s Phase 2a clinical, safety and exploratory transcriptomic results; evidence of treatment activity and RIPK2 inhibition; selection of 20 mg BID for further development; OD-001’s potential efficacy, safety and use as an oral monotherapy, in combination with vedolizumab or for maintenance treatment; and the design, timing and anticipated results of planned Phase 2b monotherapy and Phase 2a combination trials, including expected topline induction results in the second half of 2027.

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 reflect Odyssey’s current expectations and involve risks and uncertainties that could cause actual results to differ materially. These include the inherent limitations of an open-label trial without a concurrent placebo control; potential uncertainty about exploratory transcriptomic findings; the possibility of different outcomes in future trials; clinical, regulatory, competitive and third-party risks; and other factors described under “Risk Factors” in Odyssey’s most recent Form 10-Q and other SEC filings. Forward-looking statements contained in this press release are made as of this date, and Odyssey undertakes no obligation to update these statements except as required by law.

Contacts

Benjamin Navon
Senior Director, Communications
(857) 431-8785

For investors
investors@odysseytx.com

For media
media@odysseytx.com

FAQ

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What did Odyssey Therapeutics' OD-001 Phase 2a trial show on its primary endpoint?

OD-001 met its primary endpoint with a mean 2.4-point reduction from baseline in modified Mayo score at Week 12 (p<0.001). The completed induction analysis included all 56 efficacy-evaluable patients with moderate-to-severe ulcerative colitis. The trial was open-label and had no concurrent placebo control.

When does Odyssey Therapeutics expect results from the next OD-001 trials?

Odyssey expects topline induction results from its planned Phase 2b monotherapy and Phase 2a combination trials in the second half of 2027. Both trials will be randomized and double-blind.

What treatments will Odyssey Therapeutics compare in the next OD-001 trials?

The planned Phase 2b trial will test OD-001 monotherapy against placebo, while the Phase 2a combination trial will compare OD-001 plus vedolizumab with vedolizumab plus placebo.

How did prior treatment exposure affect remission in Odyssey Therapeutics' OD-001 trial?

At Week 12, clinical remission with 20 mg twice daily was 29% in advanced therapy-naïve patients (n=28) and 23% in advanced therapy-experienced patients (n=13).