OD-001 / Odyssey Therap - LARVOL DELTA

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of OD-001, a RIPK2 Scaffolding Inhibitor, in Combination With Vedolizumab in Moderate to Severe Ulcerative Colitis (ACG 2026) - "This trial is expected to be actively enrolling at sites across the world beginning in the second half of 2026. Data from the induction period is anticipated in the second half of 2027 and from the maintenance period in the second half of 2028. This trial may provide the first clinical proof-of-concept evidence for combining RIPK2 scaffolding inhibition with vedolizumab to enhance induction of response and remission in UC relative to vedolizumab alone, and using OD-001 oral monotherapy to sustain clinical benefit during maintenance."

Clinical • Combination therapy • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • RIPK2

Odyssey Therapeutics’ OD-001 Meets Key Endpoints in Ulcerative Colitis Trial (Minichart) - "The trial demonstrated a statistically significant change in the modified Mayo Clinic Score (MMCS) of -2.6 (p < 0.001) from baseline at week 12, across a consolidated patient population of 49 patients from both parts of the trial...Key efficacy data at week 12 includes: Clinical Remission Rate: 27%, versus a historic placebo rate of 10%; Endoscopic Improvement: Achieved in a majority of patients versus a 15% historic placebo benchmark; Clinical Response: High, versus a 37% historic placebo benchmark; Histologic-Endoscopic Mucosal Improvement (HEMI): Achieved in 62% of patients who reached clinical remission...The company will present updated results, including additional patients and biomarker data, at the United European Gastroenterology Week (UEG) in October 2026, followed by a Phase 2b monotherapy readout and Phase 2a combination data (with vedolizumab) expected in H2 2027."

P2a data • P2b data • Ulcerative Colitis

SAFETY AND EFFICACY OF OD-001, A FIRST-IN-CLASS ORAL RIPK2 SCAFFOLDING INHIBITOR, IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM A PHASE 2A TRIAL (NCT06850727) (UEGW 2026) - P2 | No abstract available

Clinical • P2a data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • RIPK2

Anticipated Key Clinical Milestones: OD-001 (RIPK2 scaffolding inhibitor) (GlobeNewswire) - "Initiate a Phase 2b monotherapy trial and a Phase 2a combination trial with vedolizumab in the second half of 2026, with results from both studies expected in the second half of 2027. Results from the signal-seeking Phase 2a monotherapy trial, for which topline induction data were released in April 2026, will be presented in the second half of 2026."

New P2 trial • P2a data • Ulcerative Colitis

Pipeline Highlights: OD-001: Small molecule RIPK2 scaffolding inhibitor (GlobeNewswire) - "Achieved clinical proof-of-concept in a Phase 2a clinical trial of OD-001 in moderate to severe ulcerative colitis. 49 patients completed 12 weeks of treatment with OD-001 and were eligible for efficacy analysis. OD-001 was well tolerated at both doses tested and observed to be efficacious in patients naïve, or experienced, to advanced therapies, with 27% of patients achieving clinical remission and 61% achieving clinical response."

P2a data • Ulcerative Colitis

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=57 | Recruiting | Sponsor: Odyssey Therapeutics | Trial primary completion date: Jan 2026 ➔ Apr 2026

Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=57 | Recruiting | Sponsor: Odyssey Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase 2a Study of the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=57 | Not yet recruiting | Sponsor: Odyssey Therapeutics

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=101 | Completed | Sponsor: Odyssey Therapeutics | Recruiting ➔ Completed | N=156 ➔ 101 | Trial completion date: Oct 2025 ➔ Nov 2024 | Trial primary completion date: May 2025 ➔ Nov 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Seronegative Spondyloarthropathies • Spondylarthritis • Ulcerative Colitis

Odyssey Therapeutics to Present New Data on its Clinical-Stage RIPK2 Scaffolding Inhibitor, OD-07656, at the American College of Gastroenterology (ACG) Annual Scientific Meeting 2024 (Businesswire) - "Odyssey Therapeutics, Inc...announced that new translational data for its receptor-interacting protein kinase 2 (RIPK2) scaffolding inhibitor product candidate, OD-07656, will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Philadelphia, held October 25-30, 2024. Activation of RIPK2 in innate immune cells is linked to multiple aspects of inflammatory bowel disease (IBD) pathogenesis through its role as a signal transducer and amplifier of cytokine production."

Clinical data • Immunology • Inflammatory Bowel Disease

Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: Odyssey Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Seronegative Spondyloarthropathies • Spondylarthritis • Ulcerative Colitis

Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=156 | Not yet recruiting | Sponsor: Odyssey Therapeutics

New P1 trial • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Seronegative Spondyloarthropathies • Spondylarthritis • Ulcerative Colitis