FDA News

Gene transfer treatment for HFrEF receives FDA fast track designation

Renova Therapeutics announced the FDA granted fast track status to its gene transfer treatment for patients with HF with reduced ejection fraction.

According to a press release from the company, the gene transfer (RT-100 AC6) infuses an inactivated adenovirus vector encoding human adenylyl cyclase type 6 (Ad5.hAC6) into the arteries that feed the heart during cardiac catheterization.

The AC6 protein is commonly found in heart muscle cells that regulates heart function.

A phase 2 trial showed that one-time administration of the gene transfer therapy safely increased heart function beyond optimal HF therapy, and HF hospitalization rates were lower at 12 months among patients who received the gene transfer therapy, according to the release.

The FDA’s fast track program expedites development and review of drugs and biologics with the potential to treat serious conditions and unmet medical needs, streamlines communication with the FDA during development and review processes, allows for a Rolling Review of an application and provides quicker access of the therapy to patients via priority review eligibility, according to the release.

In the upcoming randomized, placebo-controlled, double-blind, multicenter, phase 3 FLOURISH trial, researchers will assess the safety and efficacy of intracoronary delivery of the gene transfer therapy, the company stated in the release.

“Despite some medical advancements, heart failure remains a progressive and fatal disease affecting millions of people worldwide,” Jack W. Reich, MD, CEO and cofounder of Renova Therapeutics, said in the release. “That’s why we look forward to initiating a phase 3 trial with RT-100 early next year, with hopes of eventually submitting a [Biologics License Application] and ultimately bringing this life-changing therapeutic to patients as quickly as possible.”

Disclosure: Reich is an employee of Renova Therapeutics.

Renova Therapeutics announced the FDA granted fast track status to its gene transfer treatment for patients with HF with reduced ejection fraction.

According to a press release from the company, the gene transfer (RT-100 AC6) infuses an inactivated adenovirus vector encoding human adenylyl cyclase type 6 (Ad5.hAC6) into the arteries that feed the heart during cardiac catheterization.

The AC6 protein is commonly found in heart muscle cells that regulates heart function.

A phase 2 trial showed that one-time administration of the gene transfer therapy safely increased heart function beyond optimal HF therapy, and HF hospitalization rates were lower at 12 months among patients who received the gene transfer therapy, according to the release.

The FDA’s fast track program expedites development and review of drugs and biologics with the potential to treat serious conditions and unmet medical needs, streamlines communication with the FDA during development and review processes, allows for a Rolling Review of an application and provides quicker access of the therapy to patients via priority review eligibility, according to the release.

In the upcoming randomized, placebo-controlled, double-blind, multicenter, phase 3 FLOURISH trial, researchers will assess the safety and efficacy of intracoronary delivery of the gene transfer therapy, the company stated in the release.

“Despite some medical advancements, heart failure remains a progressive and fatal disease affecting millions of people worldwide,” Jack W. Reich, MD, CEO and cofounder of Renova Therapeutics, said in the release. “That’s why we look forward to initiating a phase 3 trial with RT-100 early next year, with hopes of eventually submitting a [Biologics License Application] and ultimately bringing this life-changing therapeutic to patients as quickly as possible.”

Disclosure: Reich is an employee of Renova Therapeutics.