Last month, NuSirt Biopharma announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its development program focused on non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 

“NAFLD and NASH represent serious unmet medical needs for which there are no approved therapies,” said Joseph C. Cook, Jr., president and executive chairman of the board of NuSirt Biopharma. “It is estimated that 75-100 million people in the U.S. have NAFLD, and 10-20 million have progressed to NASH.” 

NuSirt’s patented technology combines a naturally occurring amino acid, leucine, with existing pharmaceuticals. In pre-clinical studies, NuSirt’s triple combination of leucine, metformin and sildenafil showed the potential to reverse NAFLD, reduce symptoms of the disease, and prevent the onset of NAFLD and NASH. Additional animal studies have shown the triple combination could reverse obesity-induced liver fat accumulation, inflammation and fibrosis in mice. This research was presented at the American Association for the Study of Liver Diseases (AASLD)’s annual The Liver Meeting® in November 2015.

NuSirt also announced the start of enrollment for its Phase 2A clinical trial targeting this disease at nine U.S. research sites. The Phase 2A clinical trial, named TRIPLN, is a randomized, 16-week, placebo-controlled, double-blind study. Initial results are expected in the second half of 2016.