Thetis Pharmaceuticals

Thetis is a biopharmaceutical company developing potential first-in-class pro-resolving therapies for inflammatory diseases.

Thetis’ proprietary HEALER™ platform enables the development of bioactive lipids as patent-protected new molecular entities with enhanced bioavailability and stability, overcoming key hurdles that have historically limited their development.

Thetis’ lead candidate, TP-317, is a new molecular entity (NME) that delivers Resolvin E1 (RvE1), an endogenous lipid mediator that that offers a fundamentally new approach to treating inflammatory bowel disease (IBD). TP-317 resolves inflammation, promotes mucosal tissue repair and enhances immunological tolerance without compromising the body’s immune function. Based on this profile, TP-317 is targeted as a first-line, safe, oral therapy for Crohn’s Disease and for ulcerative colitis (UC) patients who are not well controlled on 5-ASA before escalating to biologics. Given its mucosal healing properties, TP-317 also has prospects to offer unique therapeutic value in combination with anti-TNFs, JAK inhibitors and other immunosuppressive drugs. In addition, TP-317 is anticipated to have a good safety profile, as RvE1 itself has undergone a full ICH non-clinical tox program and Phase 1 SAD/MAD studies in healthy volunteers demonstrating safety at levels in excess of the anticipated clinical dose.

Based on promising preclinical data on RvE1 from the Levy and Serhan laboratories at Brigham & Women's Hospital, TP-317 is also being evaluated for acute respiratory distress syndrome (ARDS). Thetis is currently conducting IND-enabling tox studies and is targeting IND submission in 2020.

Thetis’ other candidate, TP-352, is being developed as a first-in-class, oral therapy for non-alcoholic steatohepatitis (NASH). TP-352 offers an attractive, de-risked product profile based on the established efficacy and safety of its active moiety, docosahexaenoic acid (DHA). DHA has demonstrated efficacy in several academic clinical trials in NASH patients, with significant effects on multiple aspects of NASH pathophysiology, including steatosis, triglycerides, inflammation, and liver damage. DHA is also known to be cardioprotective, which could allow TP-352 to address the significantly elevated cardiovascular risk in NASH patients.