Benzinga | Jan 31, 2022 07:06AM EST

Can Fite Announces First Patient Enrolled In Phase IIb NASH Clinical Trial With Namodenoson

Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has enrolled the first patient in a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH.

The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with NASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks.

There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. The U.S. National Institutes of Health estimate the prevalence of NASH in the U.S. at 2-5% of the population. NASH is the leading cause for liver transplants among women and second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for liver transplants in males as well.

"Our Phase IIa study demonstrated very encouraging results based on key liver fibrosis and NASH biomarkers. We hope to see a similar therapeutic effect in a larger patient population as measured by liver biopsy," stated Can-Fite CEO Dr. Pnina Fishman.

Can-Fite has out-licensing agreements for Namodenoson in the treatment of NASH in Eastern Europe, China, and South Korea which include milestone payments and double-digit royalties upon approval and commercialization.