Novartis is considering the future of serelaxin after the drug hit another setback failing to meet key goals in a late-stage study involving patients with acute heart failure.
The Phase III RELAX-AHF-2 study failed to hit its primary endpoints of showing that serelaxin (also known as RLX030) reduced the risk of cardiovascular death or reduced worsening heart failure when added to standard therapy.
“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 of Drug Development and chief medical officer.
"We will continue to further analyse the data to better understand and learn from these results as well as evaluate next steps for the overall programme.”
Serelaxin is a recombinant form of the hormone relaxin-2, which, despite being widely known as a pregnancy hormone, as it helps the body stretch to accommodate a growing baby, occurs naturally in both men and women. The drug is believed to act through multiple mechanisms on the heart, kidneys and blood vessels.
Earlier trials on serelaxin have also produced mixed results and regulators on both sides of the Atlantic have thus far declined its approval.
AHF is a life-threatening medical condition and the leading cause of hospitalisation in people aged over 65 years, accounting for more than 15 million days in hospital each year in the EU and US. Risk of mortality after hospitalisation for AHF is high, with around one in five patients not surviving a year afterwards.