The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Renova Therapeutics’ lead product candidate, RT-100 AC6 gene transfer (Ad5.hAC6), for the treatment of heart failure with reduced ejection fraction (HFrEF).

“We’re pleased to work closely with the FDA to advance rapidly the development of RT-100 to treat heart failure patients,” said Dr. Jack W. Reich, chief executive officer and co-founder of Renova Therapeutics. “Despite some medical advancements, heart failure remains a progressive and fatal disease affecting millions of people worldwide. That’s why we look forward to initiating a Phase 3 trial with RT-100 early next year, with hopes of eventually submitting a BLA and ultimately bringing this life-changing therapeutic to patients as quickly as possible.”

RT-100 AC6 gene transfer involves infusing an inactivated adenovirus vector encoding human adenylyl cyclase type 6 (Ad5.hAC6) into the arteries that feed the heart during cardiac catheterization, a commonly performed procedure.  Results of a Phase 2 clinical trial indicate that, through a one-time administration, RT-100 safely increased heart function beyond optimal heart failure therapy. 

Renova Therapeutics will conduct a randomized, placebo-controlled, double-blind multicenter Phase 3 trial of intracoronary delivery of RT-100 to evaluate safety and efficacy. This trial is expected to commence in Q1 2018 in the United States.