TheraVasc plans to begin enrolling patients this month in a phase 2a clinical trial of its pill designed to treat peripheral artery disease.
The clinical trial, which is expected to follow 50 diabetic PAD patients for 11 weeks, could lead to big things for Cleveland-based TheraVasc. CEO Tony Giordano hopes a successful trial will position the company for a development partnership with a big drugmaker or a venture round of between $10 million and $20 million.
“We’re really excited that it’s finally getting rolling,” Giordano said. “Now we just have to get these patients in as quickly as possible, and see if the drug does what we expect it to do.”
The company is reformulating a drug — sodium nitrite — for the treatment of PAD, a condition in which narrowed arteries reduce blood flow to the limbs. The condition often afflicts diabetics and can result in the amputation of patients’ feet.
Sodium nitrite is available in injectable form, but TheraVasc is working to commercialize the drug in pill form. A capsule or tablet would not only be more user friendly, it would allow for a sustained release that would help patients maintain adequate levels of the drug over time.
In addition to measuring the drug’s safety and tolerability, the phase 2a clinical trial’s design calls for assessments of patients’ vascular integrity, walking ability and quality of life improvements at the end of the trial period, Giordano said.
Cleveland Clinic likely will be the first of eight clinical sites that will go live, with patient enrollment and dosing expected to begin this month. The University of Pennsylvania is another of the trial sites. Others will start up throughout the coming months.
TheraVasc closed a $2.1 million series A round of investment last year. Investors included JumpStart. Portal Capital, North Coast Angel Fund, Ohio TechAngels and Dayton-based Physician Investment Group. The company also last year received a $500,000 grant last year from the Global Cardiovascular Innovation Center on Cleveland Clinic’s campus, Giordano said.