Novartis reported that its Phase III RELAX-AHF-2 clinical trial of RLX030 (serelaxin) in patients with acute heart failure failed to meet its primary endpoints.
Its primary endpoint was reduction of cardiovascular death through Day 180 or reduced worsening heart failure through Day five. The drug is a relaxin receptor agonist, a recombinant version of a naturally-occurring hormone, relaxin-2.
“We are disappointed this study did not confirm the efficacy of RLX030 in acute heart failure, especially given the urgent need for effective new treatments for this condition,” said Vas Narasimhan, Novartis’ global head, Drug Development, and chief medical officer, in a statement. “We will continue to further analyze the data to better understand and learn from these results as well as evaluate next steps for the overall program.”
Reuters noted that “Serelaxin had a troubled trial history, having already failed in 2014 to win the approval of European and U.S. regulators. Novartis pressed on in the hope of eventually gathering enough evidence to change regulators’ minds, but Wednesday’s announcement that the drug failed dashes those aims.”
The European Union regulators also had doubts about the drug’s efficacy and expressed concerns over the previous trial’s structure.
The drug was viewed as a way for Novartis to bridge the gap left by the expiration date of Diovan, another cardiac drug, which lost U.S. patent protection in 2012.