Savara says Phase II Indie study of Aironite did not meet endpoints
Savara announced results from the Indie study of Aironite evaluating the use of inhaled inorganic nitrite for symptom relief in patients with heart failure with preserved ejection fraction. The study did not meet its primary endpoint of improvement in peak exercise capacity assessed by cardiopulmonary exercise testing, or its secondary endpoints. "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," said Rob Neville, chief executive officer of Savara. "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." Aironite is an investigational product that was added to Savara's pipeline as part of Savara's acquisition of Mast Therapeutics in April 2017, and the Indie study was one of two investigator sponsored Aironite studies in patients with HFpEF initiated prior to the merger. Following the negative outcome of the Indie study, Savara does not plan to support any new development of Aironite. Shares of Savara closed Friday down 28c to $10.98.