Mast Therapeutics has announced that the Duke Clinical Research Institute will serve as the coordinating center for the Heart Failure Clinical Research Network (HFN) as it conducts a Phase 2 study of AIR001 sodium nitrite inhalation solution. Earlier this year, Mast reported positive results from a Phase 2a AIR001 for the treatment of heart failure that was conducted at the Mayo Clinic.
The randomized, double-blind, placebo-controlled Phase 2 clinical study, called Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF), is expected to enroll 100 patients with heart failure with preserved ejection fraction (HFpEF). In addition to AIR001, Mast will provide nebulizers and “regulatory, technical and additional financial support” to the HFN, which is funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
Mast CEO Brian M. Culley commented, “We appreciate the NIH’s, NHLBI’s, and HFN’s recognition of the study of AIR001 in heart failure as an appropriate area of investigation. This study will accelerate efforts to define the potential efficacy of AIR001 for patients who have heart failure with preserved ejection fraction. This is an area of significant unmet need. There are more than 1 million heart failure hospitalizations each year in the US, about half are patients with HFpEF, and, currently, there are no proven effective therapeutic agents available for this large patient population.”
Read the Mast Therapeutics press release.
