Can-Fite BioPharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company's ongoing Phase IIb clinical study. Namodenoson is a small molecule orally bioavailable drug, targeting the A3 adenosine receptor, over-expressed on the surface of liver pathological cells in MASH but not normal cells. This potentially makes Namodenoson an ideal specific candidate for the treatment of MASH.

Indeed, in a Phase IIa clinical study Namodenoson, has been shown to reduce hepatic steatosis, inflammation and fibrosis, with an excellent safety profile. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA will allow for the recruitment of patients in the US. The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH.

The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, 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.