According to Mast Therapeutics the first patient has been enrolled in a Phase 2 study of its AIR001 sodium nitrite inhalation solution in patients with heart failure with preserved ejection fraction (HFpEF). The multicenter, randomized, double-blind, placebo-controlled is expected to enroll 100 patients.
The company announced earlier this year that the INDIE-HFpEF study would be sponsored by Duke Clinical Research Institute (DCRI) and conducted at centers associated with the Heart Failure Clinical Research Network (HFN). In February 2016, Mast reported positive results from a Phase 2a clinical study of AIR001 in HFpEF patients conducted at the Mayo Clinic.
Mast Therapeutics CEO Brian M. Culley said, “AIR001, a sodium nitrite solution administered via inhalation, has potential as an effective treatment for heart failure, and we are pleased that patient enrollment is underway. This study will advance our efforts to characterize the efficacy of AIR001 for patients who have heart failure with preserved ejection fraction. There are more than 1 million heart failure hospitalizations each year in the US, about half of which involve patients with HFpEF. Currently, no proven effective therapeutic agents are available for this large patient population. We look forward to continuing to support DCRI and the HFN on this study.”
AIR001 is also in Phase 2 development for the treatment of pulmonary arterial hypertension.
Read the Mast Therapeutics press release.
