TP-352 Program for Non-alcoholic Steatohepatitis (NASH)
NASH is a severe form of non-alcoholic fatty liver disease (NAFLD) characterized by liver steatosis, inflammation, and necrosis. NASH is the most common liver disease and the leading cause of end-stage liver disease worldwide. There are currently no approved drugs.
Thetis is developing TP-352 as a first-in-class, oral therapy for treatment of 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 clinical trial in NASH patients, with significant effects on multiple aspects of disease pathology, including steatosis, inflammation, and liver damage. In addition, preclinical studies in NASH models indicate potential for anti-fibrotic effects. DHA is also known to be cardioprotective, which could allow TP-352 to address the significantly elevated cardiovascular risk in NASH patients. Finally, there is a significant body of clinical and non-clinical data supporting the safety of DHA.
Developed using Thetis’ proprietary HEALER chemistry platform, TP-352 is a new molecular entity (NME) that delivers DHA with superior bioavailability compared to DHA as the natural oil, enhanced stability and formulation properties, and composition of matter patent protection. In short, TP-352 has key credentials necessary to translate the robust pharmacology of DHA into a pharmaceutical drug for treatment of NASH.