Can-Fite announces protocol design for CF102 study

Can-Fite BioPharma Ltd announced completion of phase 2 protocol design for its CF102 study for treatment of non-alcoholic fatty liver disease.

A previous study reported that due to increasing rates of obesity, about 25% of the population has NAFLD, a precursor to non-alcoholic steatohepatitis.

Researchers designed this study study as a multicenter, randomized, double blind, placebo controlled, dose-finding trial of the efficiency of CF102 to treat NAFLD. They will assign about 75 patients to one of three dosages — two different dosages of CF102 and one placebo — twice daily.

The primary endpoint is the percent change from baseline in liver triglyceride concentration. Secondary endpoints include the effects of CF102 on metabolic abnormalities, as well as relevant NAFLD biomarkers, and an assessment of the pharmacokinetics of CF102.

“We are very pleased the Phase 2 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 2 trial in liver cancer, its anti-inflammatory as well as liver protective profile, and the positive pre-clinical data in NASH models, we believe patients with NAFLD may benefit from CF102,” Pnina Fishman, PhD, Chief Executive Officer of Can-Fite, said in a press release.