Israeli-based drug development company Can-Fite BioPharma has completed the protocol design of its ensuing Phase II trial of CF102 to treat non-alcoholic fatty liver disease (NAFLD).
CF102 is a small, bioavailable, orally administered drug. It fuses selectively with the A3 adenosine receptor (A3AR), which occurs mostly in tumour cells rather than normal cells.
The Phase II trial has been designed as a multicentre, randomised, double-blinded, placebo-controlled, dose-finding study intended to determine the safety and efficacy of CF102 in treating NAFLD.
About 75 patients will be enrolled in the trial and characterised with three arms consisting of two different dosages of CF102 and a placebo administering the drug twice daily.
It will be primarily focused on determining the baseline change in liver triglyceride (fat) concentration measured by nuclear magnetic resonance spectroscopy (NMRS), as well as drug administration safety.
The study's secondary endpoint is to evaluate the effect of CF102 on metabolic abnormalities related to NAFLD.
It also includes assessing the effects of CF102 on biomarkers related to NAFLD and determining the pharmacokinetics profile of CF102 in treating NAFLD.
The A3AR biomarker will be determined before initiating the trial, while its relation with the disease will be examined after the completion of the study.
Can-Fite CEO Pnina Fishman said: "We are very pleased that the Phase II study design for the indication of NAFLD / NASH is completed and we look forward to commencing this important study.
“Based on the good safety data we have on CF102 from our current Phase II trial in liver cancer, its anti-inflammatory and liver protective profile, as well as the positive pre-clinical data in NASH models, we believe patients with NAFLD may benefit from CF102."
Options are explored to determine CF102’s efficacy in treating hepatocellular carcinoma (HCC).
Recently held pre-clinical studies have validated the ability of CF102 in improving liver pathology in a NAFLD animal model of NASH.
Image: Micrograph displaying NAFLD. Photo: courtesy of Nephron.