Nashville, Tenn. (January 26, 2016) – NuSirt Biopharma today announced results from a recently completed clinical trial in patients with type 2 diabetes using its patented technology combining leucine, an essential amino acid, and low doses of metformin. The data from this trial showed comparable improvement in several glucose measures coupled with greater improvement in liver enzymes when comparing a lower dose of metformin in combination with leucine versus full dose metformin.
“The results of this clinical trial provide additional scientific support to advance our technology into the associated NAFLD and NASH disease area,” said Joe C. Cook, Jr., executive chairman and president, NuSirt Biopharma. “With approximately 75 percent of diabetic patients suffering from NAFLD, we are hopeful that our patented technology may prove to be a useful treatment alternative for those who suffer from both diabetes and NAFLD/NASH.”
In November 2015, NuSirt initiated a clinical trial to treat patients who have confirmed NAFLD. The company has since received Fast Track designation from the US Food and Drug Administration (FDA) for its NAFLD/NASH development program. Data from this clinical trial are expected later in 2016.
The complete results from NuSirt’s Phase 2A type 2 diabetes trial are currently targeted for release at scientific sessions and in publications. While this study did not demonstrate superiority of NuSirt’s leucine and low dose metformin compared to full dose metformin in diabetes, results indicate there was a synergistic dose response when leucine was combined with metformin. These results and other NuSirt studies support the potential of the company’s related technologies in treating diseases of metabolic dysfunction and/or caloric excess such as NAFLD and NASH as well as diabetes and elevated cholesterol.
About Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)
Non-alcoholic fatty liver disease (NAFLD) is a result of fat building up in the liver, preventing the organ’s ability to remove toxins from the blood. It affects up to one-third of the general population. Although there are no known causes for NAFLD, obesity, high cholesterol, diabetes, and high blood pressure are all considered risk factors.
Non-alcoholic steatohepatitis (NASH) occurs in 10 to 30 percent of those with NAFLD. It happens when the liver of a person with NAFLD becomes inflamed, causing severe liver cell damage. Over time, this can result in permanent scarring and hardening of the liver. The consequences of NASH include cardiovascular disease, liver cancer, and liver failure.
About NuSirt Biopharma
NuSirt Biopharma, headquartered in Nashville, TN, is dedicated to improving the lives of people living with chronic metabolic diseases. The company has a unique technology platform that uses patented combinations of leucine, an essential amino acid, with existing human medicines to target diseases that may be addressed by activating sirtuin pathways. In pre-clinical studies, these combinations have shown promise in preventing and treating metabolic diseases by enabling new applications for existing pharmaceuticals and enhancing their effectiveness. For more information, please visit www.nusirt.com.