Renova Therapeutics announced it will begin a phase 3 pivotal trial of its gene transfer therapy product for the treatment of HF.
After the completion of a phase 2 trial, the company had a meeting with the FDA in which it presented the phase 2 trial results for the therapy, RT-100, along with a proposal for the phase 3 trial protocol, according to a press release.
“Renova’s FDA interactions, which were quite constructive, reinforce our plans to develop RT-100 for patients living with [HF],” Jack W. Reich, PhD, CEO and co-founder of Renova, said in the release. “We look forward to advancing to pivotal trials and eventually bringing this life-changing therapeutic to market.”
The phase 3 study will be a randomized, double blind trial of a one-time intracoronary administration of RT-100 for patients with HF and reduced LV ejection fraction and will be conducted over 60 medical centers in the U.S. Researchers will determine the effect of the therapy on reduction of HF hospitalization during 12 months of follow-up, according to the release.
The therapy targets adenylyl cyclase type 6, a protein that regulates cardiac function. There is evidence that it is downregulated in patients with HF, according to the release.
The study is planned to begin in the second half of 2017, the company stated in the release.