RELAX-AHF: Positive Results With New Acute HF Treatment

September 24, 2012

September 24, 2012 (Basel, Switzerland) — A novel recombinant form of human relaxin 2 used in the treatment of acute heart failure (AHF) reduced shortness of breath as assessed by one of two dyspnea end points, the primary end points in the RELAX-AHF  study, and also reduced all-cause mortality compared with placebo plus standard of care [1].

The early results of the study, which tested the compound RLX030, or serelaxin, were released by Novartis in advance of the American Heart Association (AHA) 2012 Scientific Sessions in Los Angeles, CA. The full results of RELAX-AHF will be presented November 6, 2012 during the late-breaking clinical-trials session at 3:45-5:35 pm.

The study included 1160 patients with AHF and systolic blood pressure >125 mm Hg randomized to treatment with serelaxin via a 48-hour intravenous infusion within 16 hours of presentation or to placebo. The dose of serelaxin, 30 µg/kg per day, was selected based on a phase 2 dose-ranging study [1].

Serelaxin is a first-in-class recombinant form of human hormone relaxin 2. During pregnancy, the hormone modulates the cardiovascular responses by increasing vasodilation and renal function. Investigators also note that relaxin can modulate various important hemodynamic and neurohormonal effects, such as increases in cardiac output and decreases in systemic vascular resistance, pulmonary capillary wedge pressure, and N-terminal pro-brain natriuretic peptide (NT-proBNP) [2].

The top-line results of RELAX-AHF were released this week in advance of the AHA presentation in November--an increasingly common practice with study data that could materially affect stock prices.