A phase III trial of Novartis’ heart failure drug candidate serelaxin has shown that it reduced mortality, setting the company up to start registration discussions with regulatory authorities.
The RELAX-AHF study compared serelaxin (RLX030) to placebo in patients with acute heart failure over six months, and found that Novartis’ drug was effective both in reducing all-cause mortality and also improved symptoms.
The results – released ahead of the American Heart Association annual meeting in Los Angeles in November – found that the recombinant form of human relaxin 2 reduced shortness of breath (dyspnoea) using one clinical measure, although it failed to reach statistical significance for this endpoint using a different scale.
Novartis said it will “initiate discussions of the results of this single phase III study with health authorities worldwide shortly”. The company has previously identified serelaxin as one of the leading lights in its late-stage pipeline.
The study included 1,160 patients with acute heart failure, with serelaxin or placebo administered via a 48-hour intravenous infusion within 16 hours of presentation. The dose of serelaxin was 30 mcg/kg per day, with treatment given on top of standard therapy.
Novartis acquired Serelaxin when it bought Corthera in February 2010 for an upfront fee of $120m and around $500m in milestone payments.
Serelaxin is thought to work in alleviating heart failure by stimulating vasodilation and renal function, boosting cardiac output and decreasing systemic vascular resistance.
Acute heart failure is a major problem for health systems around the world, with half of all patients developing the condition dying within five years of diagnosis. The disease accounts for around two million hospitalisations each year in the EU and US.