Odyssey Therapeutics’ lead oral candidate, OD-001, reported patient benefit across multiple disease-relevant endpoints in a Phase IIa ulcerative colitis trial.
Odyssey Therapeutics went public in May 2026, raising approximately $304 million through its IPO and a concurrent private placement. Based in Boston, the company is developing treatments for autoimmune and inflammatory diseases, led by OD-001.
Odyssey’s pipeline focuses on the innate immune system, the body’s first line of defense, with the goal of intervening earlier in the inflammatory process. The strategy is meant to address what the company describes as a “therapeutic ceiling” in inflammatory bowel disease (IBD), where many patients still do not achieve sustained remission with existing therapies.
IBD is a chronic condition in which inflammation damages the gastrointestinal tract. It includes two main conditions: ulcerative colitis, which affects the colon and rectum, and Crohn’s disease, which can affect different parts of the digestive tract.
Odyssey’s most advanced program, OD-001, is designed to block RIPK2, a protein involved in early immune signaling in the gut. By targeting RIPK2, the company is aiming to act upstream in the immune response, before inflammatory signals spread more broadly.
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The company has reported proof-of-concept from a Phase IIa trial of OD-001 in ulcerative colitis. Odyssey completed dosing in the first two parts of the study, with 49 patients evaluable for the main efficacy analysis after 12 weeks of treatment. Across 53 enrolled patients, OD-001 was reported to be well tolerated, with no serious adverse events or discontinuations due to adverse events.
Based on those results, Odyssey is preparing for two additional trials expected to begin in the second half of 2026.
One will test OD-001 on its own in a randomized, double-blind, placebo-controlled Phase IIb trial. The other will evaluate OD-001 in combination with vedolizumab, an approved integrin-blocking therapy used in ulcerative colitis. The combination study will test whether adding OD-001 to vedolizumab can improve outcomes compared with vedolizumab plus placebo.
Topline induction results from both studies are expected in the second half of 2027.
Odyssey is also developing OD-002, another oral drug candidate aimed at SLC15A4, a protein involved in immune signaling linked to lupus and other autoimmune diseases. The pathway is connected to cases where nucleic acids, such as DNA or RNA, help trigger inflammation.
The company said it used its AI/ML platform to help identify early drug leads for the SLC15A4 program. OD-002 is currently in IND-enabling studies, the preclinical work used to support testing in humans. If those studies support further development, Odyssey plans to submit a clinical trial application outside the US in the second half of 2026 and begin a Phase I/IIa trial in the first half of 2027.
The upcoming trial is expected to start with healthy participants before moving into patient groups, including people with cutaneous lupus erythematosus, a form of lupus that affects the skin. Results from the healthy participant portion of the trial are expected in the second half of 2027.
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Odyssey is also advancing earlier-stage programs aimed at immune pathways involved in inflammatory and autoimmune diseases.
OD-003 is a protein-based therapy designed to activate regulatory T cells, which help keep immune responses in check. Another program, OD-004, is being developed for respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). It targets TSLP and IL-33, two immune signals involved in lung inflammation.
Odyssey is also developing an IRAK4 scaffolding inhibitor and is collaborating with Terray Therapeutics on an IRF5 inhibitor, another approach aimed at immune signaling involved in autoimmune disease.
Odyssey is entering a busy immunology landscape, especially in IBD. In ulcerative colitis, Abivax recently shared Phase III maintenance results for obefazimod, another investigational oral therapy, while Sanofi and Teva are advancing duvakitug, an anti-TL1A antibody, in Phase III studies for ulcerative colitis and Crohn’s disease. Blackstone Life Sciences is providing $400 million to support the program’s development.
There has also been interest in next-gen autoimmune therapies, including UCB’s planned acquisition of Candid Therapeutics. The deal would add Candid’s lead asset, cizutamig, which is being studied in multiple Phase I trials across autoimmune diseases.
Odyssey is currently focused on evaluating OD-001 through randomized clinical trials. Supported by capital from its IPO, the company’s next scheduled clinical milestones include planned ulcerative colitis trial starts in 2026 and topline results expected in 2027.
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