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Odyssey is a clinical-stage biopharmaceutical company led by a team and board of drug hunters seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases. (Incorporated in Delaware)
We are developing medicines that are designed to precisely target disease pathology with an initial emphasis on the innate immune system.
Our most advanced programs include OD-07656, a small molecule scaffolding inhibitor of receptor-interacting protein kinase 2, or RIPK2, for which we intend to commence a Phase 2a monotherapy trial for ulcerative colitis, or UC, in the first quarter of 2025 and a Phase 2a combination trial with vedolizumab in the first half of 2026, and two preclinical programs: a small molecule scaffolding inhibitor of interleukin-1 receptor-associated kinase 4, or IRAK4, and OD-00910, an agonistic protein therapeutic targeting tumor necrosis factor receptor 2, or TNFR2, built from camelid heavy chain variable regions, or VHH, domains (which we term a V-body).
Our Phase 1 RIPK2 clinical trial was conducted in Australia and we have not yet filed an investigational new drug application, or IND, for our RIPK2 program. We anticipate conducting our RIPK2 Phase 2a trials pursuant to clinical trial applications, or CTAs, at approximately 60 sites globally, including at sites we have identified in Australia, Austria, Canada, Czech Republic, Hungary, Jordan, Lithuania, Moldova, New Zealand, Poland, Romania, Turkey and Ukraine, pending submission of such CTAs and approval and clearance to proceed under them by the applicable regulatory authority. In the future, we intend to file an IND in the United States, and, if approved, open sites in the United States.
We currently expect to file a CTA in Australia for OD-00910 by the end of 2025 and for our IRAK4 program during the first half of 2026, and, pending approval to proceed from the Australian Therapeutic Goods Association, or TGA, to commence Phase 1 trials for these programs during the first half of 2026. These programs have the potential to yield treatments for inflammatory diseases that have large addressable patient populations and lack effective treatments, including inflammatory bowel disease, or IBD, atopic dermatitis, or AD, and systemic lupus erythematosus, or SLE, and, where appropriate, we intend to pursue global marketing approval for our programs if we successfully complete the necessary clinical trials.
Note: Net loss and collaboration revenue are for the 12 months that ended Sept. 30, 2024.
(Note: Odyssey Therapeutics filed its S-1 for its IPO on Jan. 17, 2025, without disclosing the terms. Estimated IPO proceeds were $100.0 million. Background: Odyssey Therapeutics submitted confidential IPO documents to the SEC on Oct. 7, 2024.)
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