Novartis’ experimental medicine RLX030 has reportedly performed well in a late-stage clinical trial, reducing the number of deaths in patients with acute heart failure (AHF).
The Swiss drug giant said yesterday that a six-month, randomized, double-blind, placebo-controlled Phase III trial known as RELAX-AHF showed that RLX030 (serelaxin) induced a cut in the rate of all-cause mortality in patients suffering from the condition, raising hopes for a new treatment.
Full details of the trial are due to be presented at the American Heart Association congress in Los Angeles in November, but the firm did say that of two primary endpoints, using different scales to measure a reduction in shortness of breath (dyspnea), the most common symptom of AHF, only one reached statistical significance.
It also said that the drug was found to be well-tolerated in the study, and that it would initiate talks with global regulatory authorities on the Phase III data “shortly”.
RLX030, the first in a new class of medicines, is a recombinant form of the human hormone relaxin-2, which occurs naturally in the body and relaxes the blood vessels, reducing stress on the heart and kidneys.
AHF places a huge drain on healthcare systems around the world, accounting for about two million hospitalisations every year in the European Union and US, highlighting the room for new and effective treatments to better manage the condition.
