Serelaxin: Additional Phase III data

Additional data from the 6-month, double-blind, international Phase III RELAX-AHF trial in 1,161 patients showed that RLX030 plus standard of care (SOC) met the co-primary endpoint of improving dyspnea as measured by VAS scores through day 5 vs. placebo (p=0.0075), but missed the co-primary endpoint of improving patient-reported dyspnea on the Likert scale at 6, 12 and 24 hours (p=0.702). RLX030 also missed the secondary endpoints of increasing the number of days alive and out of the hospital up to day 60 vs. placebo (48.3 vs. 47.7 days, p=0.37) and of reducing the incidence of cardiovascular death or rehospitalization due to heart or kidney failure up to day 60 (76 vs. 75 events, p=0.89).

RLX030 did significantly reduce the 180-day all-cause mortality rate, a safety endpoint, vs. placebo (7.3% vs. 11.3%, p=0.02). Novartis also said RLX030 met the pre-specified endpoint of reducing the number of deaths due to cardiovascular causes up to day 180 vs. placebo (6.1% vs. 9.6%, p=0.028). Additionally, RLX030 significantly reduced the worsening signs and symptoms of heart failure up to day 14 vs. placebo (p=0.024) and reduced the mean length of stay in the hospital by 0.9 days (p=0.039) and of stay in the intensive/cardiac care unit by 0.4 days (p=0.029). Patients received RLX030 or placebo on admission to the hospital as a continuous IV infusion for up to 48 hours in combination with loop diuretics and other medicines. Data were published in The Lancet and presented at the American Heart Association meeting in Los Angeles. ...