New Study: NuSirt Technology Demonstrates Potential As New Type 2 Diabetes Therapy

NASHVILLE, Tenn.--(BUSINESS WIRE)--NuSirt Biopharma today announced that new research published in the July 2015 issue of Metabolism demonstrates that its patented technology combining leucine, an amino acid, and metformin, a widely prescribed diabetes medication, has the potential to become an improved treatment for Type 2 diabetes.

“The key to effectively managing the growing type 2 diabetes epidemic is not necessarily to develop new medications, but to ensure that the medications we already have are being optimally utilized”

“Metformin is a very commonly prescribed and effective medication that helps people with Type 2 diabetes control their blood sugar,” said Joe Cook Jr., executive chair and president of NuSirt Biopharma. “Unfortunately, its side effects can lead some people to not take it as prescribed. This study indicates that NuSirt’s combination of leucine and metformin may be able to reduce the amount of metformin needed to effectively control blood sugar, which may reduce side effects and improve patient compliance.”

In the published paper, “Leucine amplifies the effects of metformin on insulin sensitivity and glycemic control in diet-induced mice,” researchers from Georgia State University’s Center for Obesity Reversal and NuSirt detailed a study that assesses the potential of coupling leucine and metformin to improve glycemic control and insulin sensitivity in diet-induced obese mice.

Today, metformin is considered the initial drug of choice for treating Type 2 diabetes and is a very cost-effective option for patients. However, an estimated 30 percent of those who could benefit from the medication may choose not to take it as recommended by their physician because of its adverse side effects, such as gastrointestinal issues.

The pre-clinical efficacy study examined the sirtuin1/AMP kinase (Sirt1/AMPK) signaling pathway, which is a key sensor of energy status and regulates glucose and lipid metabolism. Leucine has been shown to activate Sirt1 and potentiate other sirtuin/AMPK-activators, which results in the improvement of insulin sensitivity. Researchers hypothesized that, since metformin converges on the Sirt1/AMPK pathway, leucine would be able to amplify the drug’s ability to control glucose levels.

To test this hypothesis, researchers compared the effects of a combination of leucine and very low doses of metformin on glycemic control in diet-induced, insulin-resistant mice with the effects of standard therapeutic doses of metformin for six weeks. The effects of the combination of leucine and low doses of metformin on the stimulation of Sirt1 and AMPK activities also were evaluated.

The results showed that NuSirt’s combination of leucine and sub-therapeutic doses of metformin demonstrated significant synergy in activating the Sirt1/AMPK pathway and resulted in improved glycemic control and insulin sensitivity. The combination offered comparable or improved ability to reduce hyperglycemia, or high blood glucose, improve blood glucose response to insulin, and significantly reduce fasting blood glucose and insulin levels when compared to full-dose metformin.

In fact, combining leucine and metformin enabled a metformin dose reduction of 66 percent with improved efficacy and a dose reduction of 83 percent with comparable efficacy to standard metformin dosage. These dose reductions translate into levels of metformin that are not associated with gastrointestinal distress and other adverse side effects common to the drug.

“The key to effectively managing the growing type 2 diabetes epidemic is not necessarily to develop new medications, but to ensure that the medications we already have are being optimally utilized,” said NuSirt Founder and Chief Scientific Officer Michael Zemel, Ph.D. “This study indicates that NuSirt’s combination of leucine and metformin may be able to create a useful treatment alternative for people who struggle with metformin’s side effects, opening up the use of this effective therapy to more individuals. We look forward to studying this exciting combination further.”

In late 2014, NuSirt initiated a Phase 2A clinical trial to evaluate if the results from this study could be matched in humans. This trial is concluding this summer.

NuSirt currently has protected the discovery and commercial application of its technology through an IP portfolio that includes three issued/allowed patents and 9 active patent families.

About Diabetes

According to the American Diabetes Association, more than 29 million Americans have diabetes, and an additional 86 million Americans age 20 and older have prediabetes. It is currently the seventh leading cause of death in the U.S., and its complications include blindness, kidney failure and peripheral amputation.

About NuSirt Biopharma, Inc.

NuSirt Sciences, Inc., headquartered in Nashville, is dedicated to improving the lives of people living with chronic metabolic diseases. The company has a unique technology platform that uses a patented combination of leucine, an essential amino acid, and existing human medicines targeted at diseases that may be addressed by activating sirtuin pathways. In pre-clinical studies, these combinations have shown promise in preventing and treating metabolic diseases and enhancing the effectiveness of existing pharmaceuticals. For more information, please visit www.nusirt.com.