Jul 18, 2014, 2:55pm CDT Updated: Jul 18, 2014, 3:08pm CDT


Nashville-based NuSirt Biopharma will soon begin human trials of a product designed to cut down on the side effects of diabetes medication Metformin using natural amino acid Leucine.

The product is the result of years of research on the body’s use of energy by Michael Zemel at the University of Tennessee, President and Executive Chairman Joe Cook, Jr., said. Through his research, Zemel discovered the positive effects Leucine can have on the body, Cook said, a finding that the NuSirt team initially planned to apply to “nutraceuticals” that would be sold at health stores and online.

In May of last year, however, the team pivoted to focus on combining Leucine with Metformin, one of the most commonly-prescribed medications worldwide for diabetes, but one that’s often accompanied by gastrointestinal side effects. Cook and his team claim the addition of Leucine to Metformin will allow the drug to be prescribed in lower dosage, reducing the side effects for diabetes sufferers.

NuSirt has received approval from the Food and Drug Administration to begin its first round of human clinical trials, Cook and COOBarbara Cannon said Friday. The initial round will involve eight research sites — including Nashville’s Meharry Medical College andVanderbilt University Medical Center — and about 100 patients, Cook said.

Data will be available from that study by the end of the year, the COO said, and the drug could be approved for commercial use around 2017 if all goes according to plan.

While developing a new drug can be a long, hard road, Cook said, it’s exciting to have the opportunity to create something that can “change the face of diabetes.”

And doing so in Nashville, a city known for health care but not its life sciences sector, would be an added bonus, Cannon added.