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There is no U.S. FDA approved therapy on the market today for Nonalcoholic steatohepatitis (NASH), a chronic liver disease found in adults and children. Between 5.6 and 8.4 million Americans are living with NASH today and this number is expected to jump to 25 million by 2025, driven by rising obesity rates. NAFLD, the liver disease which is a precursor to NASH, afflicts an estimated 30 million people today.
These numbers are astounding, considering the fact that diabetes is widely considered an epidemic because it impacts 29 million Americans. NAFLD and NASH can lead to cirrhosis, and in later stages, to liver cancer and liver failure.
Israel based Can-Fite BioPharma’s CF102, a drug currently in a Phase 2 trial treating hepatocellular carcinoma (HCC), the most common form of liver disease, is headed into clinical trials for the treatment of NAFLD/NASH. While about 40,000 Americans are diagnosed with liver cancer today, this number may increase with the rising incidence of NASH.
Several other companies are developing potential treatments for NAFLD and NASH. As these drugs come to market, Deutsche Bank projects their annual sales to be in the $35 – $40 billion range by 2025. The CEO of Allergan, Brent Saunders, one of the companies developing NAFLD/NASH drugs described the situation, “With the increasing rates of diabetes, obesity and other metabolic conditions in the U.S. and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society. It is important that we invest in new treatments today so that healthcare systems, providers and patients have treatment options to face this challenge in the coming years.”
CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. Preclinical studies have shown CF102’s efficacy in reducing liver fat in NASH models as compared to placebo, improving liver function, and regenerating liver cells.
Can-Fite reported it has submitted the clinical trial protocol for its Phase 2 study of CF102 in the treatment of NAFLD to leading Institutional Review Boards in Israel. Top medical centers in Israel, including Hadassah Medical Center and Rabin Medical Center are expected to participate in the planned study by enrolling and treating patients.
The multicenter, randomized, double-blinded, placebo-controlled, dose-finding study will enroll 60 patients with NAFLD, with or without NASH. The study will have three arms, including two different dosages of CF102 and a placebo, given via oral tablets twice daily. The study’s primary endpoints will be percent change from baseline in liver triglyceride (fat) concentration. Can-Fite’s drugs, based on A3AR, have been studied in over 1,000 patients.
Given the size and scope of the NAFLD/NASH patient population in the U.S. and around the world, healthcare systems can benefit from several different drugs for this indication. A few drugs are in Phase 3 and some others are in Phase 2. Can-Fite’s CF-102 could emerge as a safe and effective choice.