Animal studies show that company’s unique technology can significantly reduce the amount of metformin needed to control blood sugar; human trials a next step
Nashville, Tenn. (July 7, 2014) – NuSirt Biopharma, Inc., today announced that two papers presented at the American Diabetes Association (ADA) 74th Scientific Sessions demonstrate that the company’s patented technology enhances the ability of a common Type 2 diabetes medication to better control blood sugar.
The papers, “Leucine Amplifies the Effects of Metformin on Insulin Sensitivity and Glycemic Control in Diet-induced Obese Mice” and “Synergy between Metformin and Leucine in Sirtuin Signaling and Fat Oxidation In Vitro, and in Reducing Lipid Accumulation in Diet-induced Obese Mice,” were presented by Bingzhong Xue, Ph.D., and Hang Shi, Ph.D., of Georgia State University. They detailed data from a widely accepted animal model which showed that NuSirt’s formulation of an essential amino acid, when combined with low doses of the generic diabetes medication metformin, can contribute to substantial improvement in glucose control and a reduction in fatty deposits in the liver.
“Metformin is a very effective medication, but millions of diabetics struggle with its side effects,” said Joe Cook, Jr., president and executive chairman of the board of NuSirt Biopharma. “These studies suggest that NuSirt’s unique compound may be able to lower the amount of metformin that is needed to maintain adequate blood sugar levels. A lower dose of metformin might contribute to a reduction in common metformin side effects. If these results are confirmed in human studies and approved by the U.S. Food and Drug Administration, NuSirt technology could establish a new approach to controlling blood glucose and helping people effectively treat and control their diabetes.”
Diabetes affects more than 29 million Americans, and an additional 86 million Americans age 20 and older have prediabetes. It is the leading cause of adult blindness, kidney failure and peripheral amputation, and the seventh leading cause of death in the U.S. Most diabetics take oral medications to control their blood sugar, and the medication most often prescribed is metformin. Many people who take metformin experience side effects, such as gastrointestinal issues, muscle pain, fatigue and headaches, which can cause them not take the medication as recommended by their physicians.
The data presented at the ADA Scientific Sessions shows that NuSirt’s patented technology can amplify metformin’s effectiveness while reducing its required dosage. Based on this data and other results, NuSirt is preparing to initiate a clinical trial to test whether the combination of NuSirt technology and low doses of metformin can demonstrate similar or superior glucose control with reduced side effects in humans. This Phase 2A clinical trial is targeted to begin enrolling patients in July, and results are expected by year end.
NuSirt’s technology platform is based on using a unique and patented blend of existing pharmaceutical compounds, coupled with leucine, an essential amino acid. This combination is designed to activate sirtuin pathways with the goal of preventing and treating metabolic diseases.
“Researchers have been trying to find effective ways to activate sirtuin pathways for many years,” said Michael Zemel, Ph.D, founder and chief scientific officer of NuSirt Biopharma. “Several synthetic formulas have been attempted, but, thus far, none have been successful. NuSirt has taken a unique approach to the sirtuin challenge, combining natural compounds with established safety profiles to activate key pathways. Our goal is to appropriately employ this technology to change the lives of millions of people with diabetes and other metabolic disorders.”
NuSirt has protected the discovery and commercial application of its technology through an extensive IP portfolio that includes two issued patents and 13 active patent applications.
About NuSirt Biopharma, Inc.
NuSirt Biopharma, Inc., headquartered in Nashville, is dedicated to improving the lives of people living with chronic diseases associated with obesity and aging. The company has a unique technology platform that uses a patented combination of natural compounds to activate sirtuin pathways. These compounds have shown promise in preventing and treating metabolic diseases and enhancing the effectiveness of existing pharmaceuticals. For more information, please visit www.nusirt.com.