Patient dosing begins in Phase 2a studies of AIR001 for the treatment of heart failure

Mast Therapeutics has announced that the first patients have been dosed in two Phase 2a studies of AIR001 sodium nitrite inhalation solution for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). A third Phase 2a study is due to start later this year. Mast acquired AIR001, which was being developed as a treatment for pulmonary arterial hypertension (PAH), in 2014 when it acquired Aires Pharmaceuticals.

In September 2014, the company announced that results from a Phase 2 study of AIR001 for the treatment of PAH that had been abandoned by Aires prior to the acquisition showed positive hemodynamic effects and that a series of Phase 2a studies of AIR001 for the treatment of heart failure was planned.

Mast CEO Brian M. Culley commented, “We are pleased to report that patient dosing recently began in these Phase 2a studies of AIR001. Last year, we reported positive top-line results from a Phase 2 study of AIR001 which demonstrated improvements in hemodynamic parameters and exercise capacity and showed that AIR001 was well-tolerated, with no treatment-related serious adverse events. That data showed benefits consistent with prior studies of AIR001, supporting our plans for continued development. We believe the hemodynamic benefits of AIR001 are particularly suited to a HFpEF population with elevated pulmonary artery and pulmonary capillary wedge pressures, for which no FDA-approved therapies are currently available. We anticipate reporting preliminary data from these Phase 2a studies beginning the second half of this year.”

Read the Mast Therapeutics press release.