[August 20, 2014]

NuSirt Biopharma Launches First Clinical Trial

NuSirt Biopharma, Inc., is initiating a clinical trial with a goal of demonstrating whether the company's patented technology may enhance the ability of a common Type 2 diabetes medication, metformin, to control blood sugar. The primary design of this Phase 2A trial is to test whether the combination of NuSirt technology and three different low doses of metformin can effectively control glucose levels when compared with full doses of metformin alone. In this trial, NuSirt's technology employs a patented blend of leucine, an essential amino acid, coupled with an existing pharmaceutical compound.

"Metformin is the most commonly prescribed oral medication to help those with Type 2 diabetes control their blood sugar. However, the side effects of metformin have been reported to cause people to not take it as frequently as their doctors suggest or stop taking it altogether," said Joseph C. Cook, Jr., president and executive chairman of the board of NuSirt Biopharma. "We are hopeful that this trial will demonstrate that NuSirt's technology can be used with significantly lower doses of metformin and maintain satisfactory blood sugar levels. A new diabetes medicine that incorporates lower doses of metformin may reduce side effects and help patients take the medication as prescribed."

As reported at the American Diabetes Association's 74^th Scientific Sessions held in San Francisco this year, animal studies have shown that NuSirt's technology can amplify metformin's effectiveness while reducing its required dosage, contributing to substantial improvement in glucose control and a reduction in fatty deposits in the liver. The clinical trial now underway is designed to examine the effects of this patented combination in humans.

Diabetes is the seventh leading cause of death in the U.S., and its complications include blindness, kidney failure and peripheral amputation. 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.

"We believe the key to helping those with Type 2 diabetes better manage their disease isn't the development of new drugs, but finding ways to encourage more effective use of medicines that already exist," said Michael Zemel, Ph.D., founder and chief scientific officer of NuSirt Biopharma. "If we are able to reduce metformin's side effects and strengthen its effectiveness, NuSirt technology has the potential to help establish a new approach to treating Type 2 diabetes."

NuSirt's Phase 2A trial is a randomized, double-blind, active controlled study with an enrollment goal of more than 100 subjects who have Type 2 diabetes. The study will contain four different treatment arms, three of which will incorporate NuSirt technology in combination with much lower doses of metformin. The fourth arm will receive full label doses of metformin alone, and follow standard clinical guidelines.

During the course of the study, participants will wear a blood sugar monitoring device and measure their blood glucose frequently.

The primary objective of the trial is to evaluate the change in fasting plasma glucose from baseline to the end of the 28 day study period. Secondary objectives are to evaluate changes in fasting plasma insulin and lipid levels, changes in glucose profiles, and effects on gastrointestinal symptoms.

The NuSirt trial is being conducted at eight sites across the U.S.:

• Catalina Research Institute in Chino, Calif.
• Medical Research South in Charleston, S.C.
• Meharry Medical College in Nashville, Tenn.
• Meridian Research in Savannah, Ga.
• Meridien Research in Tampa, Fla.
• Palm Beach Research in Palm Beach, Fla.
• Sterling Research in Cincinnati, Oh.
• Vanderbilt Medical Center in Nashville, Tenn.

Initial results from this Phase 2A study are expected by year end. If the trial is successful, NuSirt's current business plan calls for initiating a Phase 2B study with an enrollment goal of approximately 500 participants who will be monitored over a six-month period.

For more information about the trial, contact [email protected].

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 leucine, an essential amino acid, and existing human medicines targeted at diseases that may be addressed by activating sirtuin pathways. 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.

[ Back To TMCnet.com's Homepage ]