- Thinly traded micro cap Savara (NASDAQ:SVRA) slumps 23% premarket on light volume in response to its announcement that a Phase 2 clinical trial, INDIE, assessing Aironite (sodium nitrite inhalation solution) in heart failure patients with preserved ejection fraction (HFpEF) did not achieve the primary endpoint or secondary endpoints. The results were presented at the American College of Cardiology Annual Scientific Sessions & Expo in Orlando, FL.
- Treatment with Aironite failed to demonstrate an improvement in peak exercise capacity as determined by cardiopulmonary exercise testing. Specifically, the primary endpoint of the 105-subject study was peak oxygen consumption after four weeks of therapy compared to placebo.
- Secondary endpoints included submaximal activity tolerance chronically, quality of life measures, chronic filling pressures as assessed by echocardiography and natriuretic peptide levels, ventilatory efficiency at maximum exercise and submaximal exercise capacity at peak drug levels.
- Aironite is an inhaled formulation of sodium nitrite. The company acquired the product via its acquisition of Mast Therapeutics about a year ago.