SAN DIEGO, Nov. 1, 2016 /PRNewswire-USNewswire/ -- Renova™ Therapeutics, a biotechnology company developing gene therapy treatments for congestive heart failure and type 2 diabetes, announced today that it has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for its lead gene therapy product candidate, RT-100 AC6 gene transfer for the treatment of patients with heart failure and reduced ejection fraction.
The FDA meeting - for which Renova Therapeutics submitted AC6 gene transfer Phase 2 trial results along with a proposed Phase 3 clinical trial protocol - was the next step in the company's efforts to propel forward the development of this novel gene therapy for heart failure patients. "Renova's FDA interactions, which were quite constructive, reinforce our plans to develop RT-100 for patients living with heart failure," said Jack W. Reich, Ph.D., CEO and Co-founder of Renova Therapeutics. "We look forward to advancing to pivotal trials and eventually bringing this life-changing therapeutic to market." Renova Therapeutics will proceed with conducting a randomized, placebo-controlled, double-blind multicenter Phase 3 trial of a one-time intracoronary administration of adenovirus 5 encoding human AC6 (known as RT-100) for patients with heart failure and reduced left ventricular ejection fraction. The primary endpoint will be the reduction of the event rate of all - first and repeat - heart failure hospitalizations occurring after RT-100 intracoronary injection from baseline to 12 months (the study period). Patient safety will continue to be monitored during a follow-up period following completion of the study.