Lead candidate heart failure treatment receives FDA Fast Track designation. 

Biotechnology company, Renova Therapeutics, a developer of gene and peptide-based treatments for heart and metabolic disease, announced that the FDA has granted Fast Track designation for its lead candidate, RT-100 AC6 gene transfer (Ad5.hAC6), and intended for treating heart failure with reduced ejection fraction (HFrEF).

Designed to expedite and accelerate the development and review of drugs that address unmet medical needs or treat life-threatening diseases and disorders, the Fast Track designation allows a closer more frequent relationship with regulators to speed the process and reduce “red tape.” Renova noted that this designation paves the way for Rolling Review of a New Drug Application (NDA) or Biologic License Application (BLA), as a company can submit individual sections of the application for review as they are completed, rather than having to wait for the entire document to be finished before submittal. Fast Track status also sets up Renova’s eligibility for Priority Review if all relevant criteria are provided and can help speed the process further.

CEO and Co-founder of Renova Therapeutics, Dr. Jack W. Reich, noted optimistically: "We're pleased to work closely with the FDA to advance rapidly the development of RT-100 to treat heart failure patients. 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."

TR-100 AC6 involves infusing an inactivated adenovirus vector encoding human adenylyl cyclase type 6 (Ad5.hAC6) into arteries feeding the heart during catheterization. Renova explained that the AC6 protein is propagated in heart muscle tissue that regulates the organ’s function and that in some patients it is down-regulated in heart-failure patients. The results of its Phase II trial found that a single administration of TR-100 increased heart function better than what is considered the optimal therapy.

Renova said the treatment lowered heart-failure related hospitalization at 12 months and that metric will be the primary endpoint for the therapy’s pending Phase III trial.