Namodenoson Enters Phase II Trial for Treatment of NAFLD/NASH

Can-Fite BioPharma provided an update on a Phase II clinical trial to evaluate its liver drug candidate Namodenoson (CF102) in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

Namodenoson drug supply for the Phase II trial has been paid for and is ready to be administered to patients. Institutional Review Boards (IRBs) at Hadassah Medical Center and Rabin Medical Center have approved the trial protocol. Can-Fite estimates the cost of this Phase II trial to be less than $1 million.

Pre-clinical data demonstrated that Namodenoson has hepato-protective effects; helps support liver function by reducing liver fat in NASH models as compared to placebo; inhibits and prevents the progression of liver fibrosis; improves liver function; and regenerates liver cells.

"We believe that Namodenoson's high safety profile, based on robust clinical and pre-clinical findings, positions our liver drug as a promising candidate among the drugs currently under development for NASH in the market today," Can-Fite CEO Dr. Pnina Fishman said. "NAFLD and NASH are now widely recognized as a significant public health risk, driven by growing rates of diabetes and obesity. Can-Fite and other leading pharmaceutical and biotechnology companies are working hard to bring safe and effective treatments to this market in need."

Can-Fite will present its latest findings on Namodenoson's role in liver function at the First International Conference on Fatty Liver in Spain. Recent findings include namodenoson prevented liver (hepatic) fibrosis progression in a mouse model of liver fibrosis. Liver fibrosis is the excessive accumulation of scar tissue resulting from ongoing inflammation. It can result in diminished blood flow throughout the liver and is associated with NAFLD. The Namodenoson treated group exhibited normal liver under macroscopic view, no accumulation of fluid (ascites), a low fibrosis profile, and lower serum levels of transaminases as compared to the control group.

In a dose depending manner, Namodenoson inhibited the growth and proliferation of the liver fibrosis cells in pre-clinical studies on fibrogenic hepatic stellate cells. Namodenoson improved liver pathology in a NAFLD/diabetes animal model of NASH. Namodenoson had a statistically significant reduction in NAFLD activity score compared to placebo.