Savara Pharmaceuticals has presented interim results from a Phase 2 study of Aironite sodium nitrite inhalation solution for the treatment of pulmonary hypertension at the 4th Annual Drug Discovery and Development Symposium for Pulmonary Hypertension.
Savara acquired Aironite when Mast Therapeutics merged with the company earlier this year. Mast had acquired Aironite (AIR001) when it acquired Aires Pharmaceutical in 2014.
The open-label study has so far enrolled 41 patients and expects to enroll 50 patients with pulmonary hypertension resulting from a variety of causes. Data from 10 patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) show significant reductions in right atrial pressure, systolic and diastolic right ventricular pressure, systolic and diastolic pulmonary artery pressure, and pulmonary capillary wedge pressure.
Savara Chief Operating Officer Taneli Jouhikainen commented, “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. 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.”
According to Savara, two other Phase 2 studies of Aironite in patients with HFpEF, the INDIE and INABLE studies, are ongoing.
Read the Savara press release.
