Savara : Aironite Fails To Meet Primary Endpoint In Indie Phase 2 Study

(RTTNews) - Savara Inc. (SVRA) announced results from the INDIE study of Aironite or sodium nitrite inhalation solution evaluating the use of inhaled inorganic nitrite for symptom relief in patients with heart failure with preserved ejection fraction or HFpEF. The study did not meet its primary endpoint of improvement in peak exercise capacity assessed by cardiopulmonary exercise testing (CPET), or its secondary endpoints.

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.