Can-Fite BioPharma has concluded preparations for its Phase 2 trial evaluating namodenoson (CF102) for the treatment of non-alcoholic fatty liver disease (NAFLD).
The study will be conducted in two leading medical institutions in Israel, Hadassah Medical Center and Rabin Medical Center, and the company expects to begin enrolling patients for the trial within weeks.
“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 [non-alcoholic steatohepatitis] in the market today,” Can-Fite CEO Pnina Fishman, PhD, said in a press release. “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.”
“Having concluded all of our preparations for the Phase II NAFLD/NASH trial, we look forward to announcing the commencement of patient enrollment in the coming weeks,” said Fishman.
Namodenoson is a small oral inhibitor of the A3 adenosine receptor, a protein that is highly expressed in diseased cells, but is nearly absent in normal cells. Preclinical and clinical studies of namodenoson have shown it has strong liver protective properties and anti-tumor effect in hepatocellular carcinoma.
Can-Fite’s latest findings on namodenoson, to be presented at the 1st International Conference on Fatty Liver in Seville, Spain June 1-3, have revealed that the drug prevented the progression of liver fibrosis and induced liver regeneration following partial hepatectomy (surgical removal or part of the liver) in mice.
Liver fibrosis is a condition that can arise in NAFLD patients due to excess inflammation. But in namodenoson-treated mice, the drug inhibited the growth and proliferation of the fibrotic cells, and the livers seemed normal under macroscopic view.
In a mouse model of NASH, namodenoson also was found to reduce NAFLD activity compared to placebo.
Additionally, the company announced that namodenoson has shown a favourable safety profile, without liver toxicity, in a Phase 1/2 trial for hepatocellular carcinoma (HCC).
Can-Fite has received orphan drug designation for namodenoson in Europe and in the U.S., as well as fast track status in the U.S. as a second line treatment for HCC.
The new NAFLD Phase 2 trial (NCT02927314) is a multi-center, randomized, double-blind, placebo-controlled study, designed to assess the safety and effectiveness of namodenoson in the treatment of patients with NAFLD, with or without NASH.
The study will enroll 60 patients who will be randomized to receive one of two namodenoson doses, or a placebo, orally, twice daily. Its main goals are to evaluate the percent change in liver fat concentration, and the safety of the drug.
Secondary objectives include assessment of metabolic abnormalities, including body weight, waist circumference, serum fat (triglyceride) and “bad” cholesterol levels, and levels of liver enzymes.