NuSirt also announced the start of enrollment for its Phase 2A clinical trial targeting this disease at nine U.S. research sites.
NuSirt Biopharma president and executive chairman of the board Joseph Cook said: "NAFLD and NASH represent serious unmet medical needs for which there are no approved therapies.
"It is estimated that 75-100 million people in the U.S. have NAFLD, and 10-20 million have progressed to NASH. The NuSirt team is dedicated to improving the lives of those with serious metabolic diseases. We are delighted to have received Fast Track designation, which is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation helps get important new drugs to patients earlier."
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 that 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.
The Phase 2A clinical trial, named TRIPLN, is a randomized, 16-week, placebo-controlled, double-blind study. The TRIPLN study is evaluating the change in liver fat content in subjects receiving two fixed-dose combinations of NuSirt’s patented triple combination of leucine, metformin and sildenafil. Secondary objectives include assessing a variety of liver, metabolic and inflammatory markers. Initial results of the TRIPLN study are expected the 2H 2016.
NuSirt Biopharma founder and chief scientific officer Michael Zemel said: "Pre-clinical studies have shown the potential of NuSirt technology to target the three pathophysiological aspects of NASH: steatosis, inflammation and fibrosis.
"As we begin our first human trial in NAFLD and NASH, we look forward to further exploring how our triple-combination therapy could help the millions affected by this disease."