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FDA grants fast track designation for potential NAFLD regimen
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NuSirt Biopharma announced that the FDA granted fast track designation for its patented technology for the treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. In addition, NuSirt began enrolling patients for its phase 2a clinical trial investigating the safety and efficacy of this technology.
In the trial, also known as TRIPLN, patients with NAFLD will be randomly assigned a placebo or one of two fixed-dose combinations of leucine, metformin and sildenafil (NuSirt) for 16 weeks, according to the release. The primary objective is to evaluate the change in liver fat content, which will be measured by proton-density-fat-fraction using magnetic resonance imaging, according to a previous press release.
“Preclinical studies have shown the potential of NuSirt technology to target the three pathophysiological aspects of NASH: steatosis, inflammation and fibrosis,” Michael Zemel, PhD, founder and chief scientific officer of NuSirt Biopharma, said in the release. “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.”
According to the NuSirt website, this combination regimen joins amino acid and leucine with existing pharmaceuticals. The regimen is a part of NuSirt’s overall technology platform, which focuses on the activation of sirtuin pathways through the administration of natural compounds in specific combinations at precise doses, according to the company’s website.
“It is estimated that 75 [to] 100 million people in the U.S. have NAFLD, and 10 [to] 20 million have progressed to NASH,” Joseph C. Cook, Jr., president and executive chairman of the board of NuSirt Biopharma, said in the release. “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.”
Preliminary results of the trial are expected to be available in early 2016.
Disclosure: Cook and Zemel are employed by NuSirt Biopharma.