Savara has announced that the Phase 2 INDIE study of Aironite sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) failed meet its primary endpoint and, as a result, the company is discontinuing development of the product.
Mast Therapeutics acquired Aironite when it acquired Aires Pharmaceuticals in 2014; in September 2016, the company said that it would drop its only other development program to focus exclusively on Aironite. Savara acquired Mast a few months later, in January 2017.
Savara was also developing Aironite for the treatment of pulmonary arterial hypertension, and in July 2017, Savara announced positive interim results from a Phase 2 study of Aironite for that indication.
The INDIE study was led by Barry Borlaug of the Mayo Clinic and coordinated by the Duke Clinical Research Institute for the Heart Failure Clinical Research Network. The study was initiated by Mast in mid-2016.
Savara CEO Rob Neville said, “We would like to thank Dr. Borlaug, the Duke Clinical Research Institute, as well as the Heart Failure Clinical Research Network for their tireless efforts in conducting the study. These results were obviously disappointing, but we hope the study will nevertheless serve to increase the understanding of the disease mechanisms in HFpEF, and perhaps help develop other treatment concepts for this difficult clinical condition. Savara’s core business focusing on the treatment of orphan lung diseases is unaffected by the results in the INDIE study, and will remain the main value driver of the company.”
Read the Savara press release.
