Gene therapy specialist Renova Therapeutics has strengthened its position in heart failure by licensing rights to an injectable peptide drug held by Janssen.
The privately-held biotech has acquired rights to Janssen's investigational new drug (IND) dossier for the injectable urocortin hormone—stresscopin—for an undisclosed amount. The move sidesteps any potential intellectual property (IP) conflict in the development for its own urocortin peptide program RT-400, which according to its website is in phase 2 development.
Renova says it is developing RT-400 for acute decompensated heart failure (ADHF), which accounts for approximately half of all heart failure-related hospitalization cases in the U.S. which number around 1.76 million a year. Treatment of patients presenting with ADHF has barely changed in recent years, with doctors still relying on an armamentarium largely based on old generic medicines.
"Obtaining this stresscopin program IND helps propel forward the development of our peptide infusion product candidate," commented Renova's CEO and co-founder Jack Reich. "With this data, we hope to see promising results as we initiate pivotal trials."
Stresscopin is thought to play a role in the body's responses to physiological stress and has been shown in preclinical studies to protect cells exposed to fluctuating oxygen levels, such as occur in the heart in cardiovascular disease. Janssen's scientists have previously shown that stresscopin and other related peptides can increase the ability of heart cells to contract.
Other companies working in ADHF include Swiss biotech Cardiorentis, which has started a phase 3 trial of ularitide (a chemically synthesized form of urodilatin) that is due to report results in April at the American College of Cardiology (ACC) meeting.
RT-400 was first listed in Renova's pipeline last year and is being positioned to complement the firm's lead gene therapy product RT-100 for congestive heart failure, which targets adenylyl cyclase type 6, a protein that regulates cardiac function.
In a phase 2 study reported in the Journal of the American Medical Association (JAMA) last year RT-100 was shown to increase cardiac function in CHF patients and is now heading into a phase 3 trial in the latter half of this year.
The phase 3 study will be a randomized, double blind trial of a one-time intracoronary administration of RT-100 in patients with heart failure and reduced left ventricular ejection fraction (LVEF), and will be conducted at more than 60 medical centers in the U.S. with 12 months of follow-up.