Can-Fite BioPharma completes enrollment in Phase II NASH study of Namodenoson
Can-Fite BioPharma announced it has completed patient enrollment in its Phase II study of Namodenoson in the treatment of NAFLD/NASH. The multicenter, randomized, double-blinded, placebo-controlled, dose-finding efficacy and safety study has enrolled 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis). Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 mg or 25 mg of oral Namodenoson, or placebo for 12 weeks. The primary endpoint of the Phase II study is the anti-inflammatory effect of the drug, as determined by mean percent change from baseline in ALT blood levels and safety. Secondary endpoints include percentage change from baseline of liver fat, as measured by MRI-PDFF. Topline results are expected in Q1 of 2020. Namodenoson has been out-licensed for the indication of NASH in South Korea and China. There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35B-$40B by 2025.