Nonalcoholic steatohepatitis (NASH) is the leading cause of disease leading to liver transplants among women and the second-leading cause for liver transplants overall. In addition, NASH is expected to become the leading indicator for liver transplants in men.
Can-Fite BioPharma Ltd. (NYSE: CANF), an Israel-based biotechnology company, is advancing a pipeline of proprietary small-molecule drugs that address inflammatory, cancer and liver diseases and has received clearance from the Israeli Ministry of Health to begin a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH.
“We are very pleased to receive the Israeli Ministry of Health’s approval to proceed with our Phase IIb NASH study. We believe that Namodenoson could offer a safe and effective treatment for NASH,” Can-Fite CEO Dr. Pnina Fishman said. “Our overall goal is to reduce the need for liver transplants and improve the quality of life and longevity of patients.”
NASH represents an urgent unmet medical need, with no U.S.-approved drug available to treat the disease. In 2016, the National Institutes of Health estimated the incidence of NASH in the United States at 2% to 5% of the population. Based on rising obesity rates, the occurrence of NASH is also rising, and by 2025, the pharmaceutical market for NASH is estimated to reach up to $40 billion.
Can-Fite expects to start patient enrollment as early as the 3rd quarter, which is nearly 3 months ahead of its initial schedule. Its previous study achieved its primary endpoint showing anti-steatotic, anti-inflammatory and anti-fibrotic effects in fighting NASH.
The Phase IIb trial will be a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH. Eligible subjects will be randomly assigned in a 2-to-1 ratio to oral doses of Namodenoson every 12 hours or a matching placebo every 12 hours for 36 weeks.
The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with NASH, as determined by the proportion of subjects who achieve a greater than or equal to a 2-point improvement in the nonalcoholic fatty liver disease (NAFLD) activity score. This would represent the current standard for judging drug activity in this population.
For more information visit www.can-fite.com.
