Top Line Results From Aironite Phase 2 Clinical Trial for the Treatment of HFpEF to Be Presented at American College of Cardiology 67th Annual Scientific Sessions & Expo on March 11th

AUSTIN, TX--(Marketwired - February 16, 2018) - Savara, Inc. (NASDAQ: SVRA), an orphan lung disease company, today reported that top line results from the multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial of Aironite, a sodium nitrite solution for inhalation via nebulization, in patients with heart failure with preserved ejection fraction (HFpEF) will be presented at the American College of Cardiology 67th Annual Scientific Sessions & Expo, to be held at the Orange County Convention Center in Orlando, Florida March 10-12, 2018.

The 100-patient study, known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study, was sponsored by Duke Clinical Research Institute (DCRI) as the Coordinating Center for the Heart Failure Clinical Research Network (HFN). The poster presentation, entitled, Inorganic Nitrite Delivery to Improve Exercise Capacity in Heart Failure with Preserved Ejection Fraction: The INDIE Trial, will be presented as part of the Late-Breaking Clinical Trials Session on March 11^th, 2018 at 11:00am ET by Barry A. Borlaug, M.D., FACC, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine, Mayo Clinic and Principal Investigator for the INDIE-HFpEF Study.

About the INDIE-HFpEF Study
The INDIE-HFpEF study was a multicenter, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of Aironite on peak exercise capacity as assessed by cardiopulmonary exercise testing (CPET). The study was sponsored and conducted by the HFN, and Savara's wholly-owned subsidiary, Aires Pharmaceuticals, Inc., which is providing the study drugs, nebulizers, as well as regulatory, technical and additional financial support for the study. One hundred patients with a diagnosis of HFpEF were enrolled across 17 clinical centers in the United States. The primary endpoint to be analyzed is the peak oxygen consumption (VO₂) after four weeks of treatment with Aironite or placebo as assessed by CPET performed at peak drug levels. Secondary objectives include (i) submaximal activity tolerance chronically, (ii) quality of life, (iii) chronic filling pressures as assessed by echocardiography and natriuretic peptide levels, (iv) ventilatory efficiency at maximal exercise, and (v) submaximal exercise capacity at peak drug levels; as well as evaluation of the safety and tolerability of Aironite.