Phase III study results for serelaxin (Novartis) for Acute Heart Failure

Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with Acute Heart Failure (AHF). The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases. The study had two primary endpoints using different scales to measure reduction in dyspnea, only one of which reached statistical significance. Dyspnea, or shortness of breath, is the most common symptom of AHF. RLX030 was well tolerated in the study. RLX030 is the first in a new class of medicines and is a recombinant form of the human hormone relaxin-2 which occurs naturally in both men and women. In women, levels of relaxin-2 rise to support important physiological changes during pregnancy. Serelaxin acts by relaxing the blood vessels, leading to reduced stress on the heart and kidneys in both men and women.