Mast Therapeutics' AIR001 Chosen for Evaluation In A 100-Patient Multicenter Phase 2 Study

Mast Therapeutics, Inc. (NYSEMKT:MSTX) reported that its product candidate AIR001, a sodium nitrite solution being developed for treatment of heart failure with preserved ejection fraction (HFpEF), has been selected by the Heart Failure Clinical Research Network (HFN) for evaluation in a 100-patient, multicenter, randomized, double-blind, placebo-controlled, Phase 2 clinical trial known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study.
According to the company’s press release:

The HFN is made up of premier clinical centers located across North America and was established to expedite clinical research on treatments and strategies to improve the management of acute and chronic heart failure. The HFN is providing the platform to conduct the INDIE-HFpEF study.  Mast Therapeutics will provide test materials, nebulizers, and regulatory, technical, and additional financial support. The Company expects to complete a contract with the HFN’s Coordinating Center, which will be the sponsor of the study, in the coming weeks.

Edwin L. Parsley, D.O., Chief Medical Officer of Mast Therapeutics, Inc. commented:

Given the results from prior clinical studies of AIR001, including decreases in right atrial and pulmonary capillary wedge pressures, as well as improvements observed in pulmonary vascular resistance and cardiac lusitrophy, AIR001 may further demonstrate its potential benefit to patients with heart failure and preserved ejection fraction in this study. We have assisted with the study development and will support training on AIR001 and nebulizer devices, as well as assist in the submission of an institutional Investigational New Drug application, which we anticipate will occur in the first quarter of this year.

Click here to view the full press release.