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 the U.S. Patent and Trademark Office (PTO) has issued a Notice of Allowance for the Company’s patent titled, “Method for treating NASH accompanied by fibrosis using CI-IB-MECA”. The allowance follows Can-Fite’s recent announcement of highly encouraging data from its Phase II study of its drug candidate Namodenoson, generically known as CI-IB-MECA, in the treatment of non-alcoholic fatty liver disease (NAFLD) with or without non-alcoholic steatohepatitis (NASH).
The allowed patent covers the use of the A3 adenosine receptor (A3AR) in reducing ectopic fat accumulation, particularly in fatty liver. The patent specifically addresses preparation of a pharmaceutical composition for reducing fat accumulation and a method of treating conditions associated with fat accumulation such as fatty liver diseases including NASH and NAFLD.
Can-Fite recently announced findings from its Phase II study of Namodenoson in the treatment of patients with NAFLD with or without NASH. The study achieved its efficacy endpoints in a dose dependent and statistically significant manner, while continuing to demonstrate a good safety profile. The Phase II data revealed that the 25 mg dose of Namodenoson resolved significantly all cases of NASH, representing 25% of the 25 mg treated group, as compared to an increase in new NASH cases in the placebo group from a baseline of 0 to 5.9%. Namodenoson dosed at 25 mg reduced hepatic fibrosis (scar tissue in the liver resulting from the liver trying to repair itself), reduced steatosis (fat buildup in the liver), and improved the FAST score, a measure for NASH (liver stiffness and an enzymatic biomarker of liver damage).
“We are very pleased to receive this Notice of Allowance from the U.S. PTO at this time, immediately following an analysis of Phase II data that show Namodenoson is highly effective in treating and reversing fatty liver. At the optimal 25 mg dosage, Namodenoson eliminated NASH in the Phase II patient population. The protection provided by the allowed patent has a high value for us, as we move forward into advanced stage clinical trials in this indication, and as we evaluate distribution partnerships for Namodenoson,” stated Can-Fite CEO, Dr. Pnina Fishman.
An estimated 85 million Americans have NAFLD, which may lead to an exponential rise in incidence of NASH, a more severe form of NAFLD, to close to 43 million Americans in the next five years. The NASH treatment market is estimated to reach $35-40 billion by 2025.