By Tom Ballard, Chief Alliance Officer, PYA
“I’m proud of our lab,” Michael Zemel says of the R&D operations that NuSirt Biopharma has in the Fairview Technology Center in the Solway area of West Knox County. And, he has every reason to make that statement.
The company, founded in 2007 by the former University of Tennessee (UT) researcher and department head, has 18 issued U.S. patents and four more that have been allowed plus broad coverage in 60 countries. Those impressive numbers are reflective of the lifetime that Zemel has devoted to the study of metabolic issues.
While the underlying interest has not changed, the path that the company has followed has evolved over the years. Today, its headquarters is in Nashville, but the R&D work continues to be housed in the former elementary school building where Zemel moved NuSirt in 2011. That makes it one of the longest tenants in the business incubator.
“We are built to address metabolic diseases caused by over nutrition and aging,” NuSirt’s Chief Scientific Officer says. Using the term “metabolic dysregulation,” Zemel says the country is facing a crisis due to the consequences of over-nourishing the human body. The problem manifests itself in a variety of ways including cardiovascular problems, non-alcoholic fatty tissue disease, and the many potential effects of obesity.
As noted in a three-part series in 2015 on the company (Part 1, Part 2 and Part 3), Zemel founded NuSirt while still at UT. He’s been focused on the work full-time since retiring from the school at the end of the spring semester in 2012.
“The last time we talked, we were moving forward with a focus on diabetes,” Zemel said when we caught-up with him in January for this update. “We completed our Phase II clinical trial. It worked well, but it wasn’t spectacular.”
As NuSirt contemplated the next steps in its evolution, Zemel said it decided to draw on “some good research we had already done on non-alcoholic fatty liver disease (NAFLD). That decision positioned us to focus on an unmet medical need rather than focusing on smaller, incremental improvements in diabetes.”
The pivot was consistent with the philosophy that Zemel and NuSirt had been following – applying pharmaceutical rigor to the nutraceutical space. “If we have pharmaceutical efficacy, we can be a drug company.”
So, NuSirt submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration, secured approval to fast track the work on fatty liver disease, and completed a Phase II trial about a year ago.
“We got encouraging data that caused us to move forward,” Zemel said, quickly adding, “We’re not a one-trick pony.”
In fact, in addition to its clinical program in NAFLD and its more severe manifestation, nonalcoholic steatohepatitis (NASH), NuSirt has developed assets in obesity, hypertension, dyslipidemia, and diabetes, and is currently conducting clinical trials for its obesity medicine. All involve leucine, a dietary amino acid that is used in combination with other drugs.
“We have data that show we can promote weight loss,” Zemel says. “NuSirt’s approach replicates the health benefits of caloric reduction. We have a safe and encouraging mechanism of action.”
All of the basic research has been based at the Fairview Technology Center.
“We could not have developed those patents without this cost-effective location,” Zemel says. “This has worked well for us.”
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