Benzinga | Jun 2, 2021 07:37AM EDT

Can-Fite To Initiate Phase IIb NASH Study with its Drug Candidate 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 received clearance from the Israeli Ministry of Health to commence a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH. Can-Fite expects to commence enrollment in Q3 2021, ahead of the prior expected start date of Q4 2021. The Company expects to expand the study at additional clinical sites in Europe. A prior Phase IIa clinical trial of Namodenoson in the treatment of NASH met study endpoints showing anti-steatotic, anti-inflammatory, and anti-fibrotic effects.

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 will be randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo every 12 hours for 36 weeks.

"We are very pleased to receive the Israeli Ministry of Health's approval to proceed with our Phase IIb NASH study. Namodenoson has the potential to offer a safe and effective treatment for NASH with the aim of reducing liver transplants and improving quality of life and longevity for patients," stated Can-Fite CEO Dr. Pnina Fishman.

NASH is a clear and urgent unmet medical need, as there currently is no U.S. approved drug to treat the disease. As of 2016, NASH was the leading cause for liver transplants among women and second leading cause for liver transplants overall. NASH is expected to become the leading indication for liver transplants in males as well. The NIH estimates the incidence of NASH in the U.S. at 2-5% of the population. Incidence is increasing based on rising obesity rates. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.