September 25th, 2012

Novartis Announces Top Line Results for Phase 3 Trial of New Acute Heart Failure Drug

Novartis has announced preliminary results from the RELAX-AHF trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea.

Novartis also reported a reduction in all-cause mortality at 6 months. However, it should be noted that the predefined secondary endpoint on ClinicalTrials.Gov was mortality at 60 days, not 6 months. (CardioExchange has requested clarification from Novartis about this point.)

In the trial, 1161 patients hospitalized with acute heart failure were randomized to placebo or an IV infusion of RLX030 for up to 48 hours.  By design, the trial had two primary efficacy endpoints measuring dyspnea, but only one of them reached statistical significance, according to the company.

The full results of RELAX-AHF are scheduled to be presented as a late-breaking clinical trial at the American Heart Association meeting in Los Angeles in November.

RLX030 is a recombinant form of the naturally occurring human hormone relaxin-2. The drug was originally developed by Corthera, Inc, which was acquired by Novartis in February 2010.

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