TheraVasc’s clinical trial of PAD drug shows safety in diabetic patients

A phase 1 trial of a peripheral artery disease drug candidate from TheraVasc demonstrated safety in diabetic patients.

The positive clinical trial data reported by Cleveland-based TheraVasc potentially puts the young company one step closer to a development partnership with a big drug maker or a venture round between $10 million and $20 million. The company will likely need to achieve one of those milestones to continue funding expensive trials of the drug, known as TV1001.

The single-dose, 12-patient phase 1 trial was intended to assess safety and blood levels of the drug. “Few” adverse events were reported, according to a statement from TheraVasc.

The company is reformulating a drug — sodium nitrite — for the treatment of peripheral artery disease (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.

TheraVasc plans to complete a phase 2a clinical trial this year. In addition to measuring the drug’s safety and tolerability, the phase 2a trial’s design calls for assessments of vascular integrity in patients, along with their walking abilities and quality of life improvements at the end of the trial period.

Animal studies have shown the drug to lead to the generation of new blood vessels in oxygen-deprived limbs, improvement in wound healing and inhibition of tissue necrosis, according to the statement.

“Based on the safety, circulating half-life levels of the drug and blood levels achieved in this study, we believe that chronic use of TV1001 will provide a disease-altering benefit to diabetic patients with PAD,” CEO Tony Giordano said.

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.