Can-Fite BioPharma says Phase II NAFLD/NASH trial to commence enrollment
Can-Fite BioPharma said it that it successfully concluded a Clinical Investigator Meeting with the principal investigators, researchers, and doctors participating as clinical investigators in the company's Phase II trial of its drug candidate Namodenoson in the treatment of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. The Phase II multicenter, randomized, double-blinded, placebo-controlled, dose-finding study of the efficacy and safety of Namodenoson in the treatment of NAFLD/NASH will enroll approximately 60 patients with NAFLD, with or without NASH. Patients will be enrolled in three arms, including two different dosages of Namodenoson and a placebo, given via oral tablets twice daily. The study's primary endpoints will be percent change from baseline in liver triglyceride concentration measured by nuclear magnetic resonance spectroscopy and safety. The Phase II trial design is based on preclinical studies showing Namodenoson's efficacy in reducing liver fat in NASH models as compared to placebo, improving liver function, and regenerating liver cells. Can-Fite's estimated cost of the Phase II trial is under $1 million. Namodenoson supplies are ready to be administered and the costs of supply have been paid. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40B.