Savara Inc (NASDAQ: SVRA) shares tumbled Monday after the company disclosed that Aironite failed to meet primary endpoint in Indie Phase 2 clinical study conducted by the Heart Failure Clinical Research Network.
The Austin, Texas-based orphan lung disease company, today announced results from the INDIE study of Aironite (sodium nitrite inhalation solution) evaluating the use of inhaled inorganic nitrite for symptom relief in patients with heart failure with preserved ejection fraction (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.
Said CEO Rob Neville, "These results were obviously disappointing, but we hope the study will nevertheless serve to increase the understanding of the disease mechanisms in HFpEF, and perhaps help develop other treatment concepts for this difficult clinical condition.
"Savara's core business focusing on the treatment of orphan lung diseases is unaffected by the results in the INDIE study, and will remain the main value driver of the company."
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.
The shares collapsed 99 cents, or 9%, in the first hour of trade Monday to $9.99, halfway into a 52-week trading range of $4.60 to $17.19
