Can-Fite BioPharma submits IND to FDA for Phase IIb trial of namodenoson

Can-Fite BioPharma announced submission of an investigational new drug, IND, application to the U.S. Food and Drug Administration, FDA, for the treatment of metabolic dysfunction-associated steatohepatitis, also known as non-alcoholic steatohepatitis, for the Company’s ongoing Phase IIb clinical study. The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. “We are eager to look at the therapeutic effect of Namodenoson in patients with MASH,” said Motti Farbstein, chief executive officer of Can-Fite. “Prior human data showed that treatment with Namodenoson leads to significant anti-MASH effects. Namodenoson’s novel liver-protective mechanism of action provides a unique opportunity to potentially improve inflammation and reduce hepatic steatosis and fibrosis which may provide important therapeutic benefits for patients.”