SAN DIEGO, Jan. 11, 2018 /PRNewswire/ -- Renova™ Therapeutics, a biotechnology company developing gene and peptide-based treatments for cardiovascular and metabolic diseases, announced today that it will present an overview of its RT-100 AC6 gene transfer Phase 3 clinical trial in a poster session at the Keystone Symposium on Heart Failure on January 14-18, 2018, in Keystone, Colorado. RT-100 is intended for the treatment of heart failure and reduced ejection fraction (HFrEF).
This randomized, placebo-controlled, double-blind multicenter trial – known as FLOURISH (Heart Failure with Reduced Left Ventricular Ejection Fraction: One-time Gene Transfer Using RT-100 – Intracoronary Administration of Adenovirus 5 encoding Human AC6) – is expected to commence in Q1 2018 in the United States (ClinicalTrials.gov Identifier: NCT03360448).
Richard McCloskey, MD, Executive Vice President of Clinical Development at Renova Therapeutics, will present details of the FLOURISH trial during a poster session on January 16, 2018.
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. AC6 is a protein found in heart muscle cells that regulates heart function and appears to be down-regulated in heart failure patients. 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. The treatment also lowered the heart failure hospitalization rate at 12 months, which will be the primary endpoint in the program's upcoming Phase 3 trial. RT-100 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
About heart failure
Heart failure is a chronic disease characterized by the inability of the heart to pump sufficient blood to meet the body's demands. It is a progressive and fatal chronic condition, and symptoms worsen over time. Heart failure afflicts more than 28 million people globally and is the only cardiovascular disease that is increasing in prevalence.1 In the United States, it is the most common cause of emergency hospital admissions in patients 65 and older.
About Renova Therapeutics
Renova Therapeutics is developing definitive, one-time gene therapies and peptide infusion treatments to restore the health of people suffering from chronic diseases. The first indications the company is pursuing are gene therapy treatments for heart failure and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company's lead product candidate, RT-100, is a treatment that delivers a therapeutic gene directly to the heart during a routine outpatient procedure and has the potential to increase heart function in millions of patients with heart failure. RT-100 has received Fast Track designation from the U.S. Food and Drug Administration. A Phase 3 trial – FLOURISH – of RT-100 is expected to commence in Q1 2018 (ClinicalTrials.gov Identifier: NCT03360448). The company's product pipeline also includes a groundbreaking gene therapy in preclinical stage for sufferers of type 2 diabetes, as well as a peptide infusion therapy for the treatment of acute decompensated heart failure. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.
1Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics–2013 update: a report from the American Heart Association. Circulation. 2013;127:e6–e245.
SOURCE Renova Therapeutics