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Positive Interim Results Of Aironite Phase 2 Study Presented At 4th Annual Drug Discovery And Development Symposium For Pulmonary Hypertension

th Annual Drug Discovery and Development Symposium for Pulmonary Hypertension on July 10th, 2017 by lead investigator Marc A. Simon, M.D., M.S., F.A.C.C., Associate Professor of Medicine, Bioengineering, and Clinical Translational Science and Director, Heart Failure Research / Clinical Hemodynamics Core Facility, at the Pittsburgh Heart, Lung, and Blood Vascular Medicine Institute at the University of Pittsburgh.

In the 41 patients enrolled to date in the study, administration of Aironite significantly improved multiple hemodynamic measures, with most pronounced improvements in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). In the 10 PH-HFpEF patients analyzed, Aironite administration resulted in significant overall decreases in right atrial pressure, systolic and diastolic right ventricular pressure, systolic and diastolic pulmonary artery pressure, and pulmonary capillary wedge pressure. Of note, pulmonary capillary wedge pressure decreased by 7.5 mmHg (95% CI –9.0 to –6.0; baseline median value 18mmHg; p < 0.05) and mean pulmonary artery pressure decreased by 7.9 mmHg (95% CI –9.4 to –6.3; baseline median value 34 mmHg; p < 0.05). Pulmonary artery compliance (Cpa) was improved by 35% (+0.97 ml/mmHg, 95% CI +0.25 to +1.68; p < 0.01). Aironite was generally well-tolerated and no significant safety concerns were identified, supporting the primary safety outcome of the study.

"These additional results build upon prior interim data published last year in the Journal of Clinical Investigation, and demonstrate that Aironite can significantly improve cardiopulmonary hemodynamics in HFpEF as well as Group 3 PH patients, both clinical conditions which are inadequately treated by currently approved medicinal treatments," stated Taneli Jouhikainen, M.D., Ph.D., Chief Operating Officer of Savara. "If the observed short-term improvements are translated into clinically meaningful functional improvements in our ongoing placebo-controlled studies in HFpEF patients, we believe the product will have exciting potential to be advanced towards Phase 3 studies and hopefully an eventual NDA filing."

About the Phase 2 Study
This is an institution-sponsored, single-center, open-label Phase 2 study, the main objective of which is to investigate the hemodynamic effects and mechanisms of action of Aironite delivered in a single escalating dose to PH patients who undergo right heart catheterization. The study will enroll patients with PH from different etiologies, comprising 20 patients with advanced PH associated with heart failure with preserved ejection fraction (HFpEF-PH), 20 patients with pulmonary arterial hypertension who may be on...