The Heart Failure Clinical Research Network (HFN), a group of prestigious clinical centers located across North America, has selected Mast Therapeutics’ product AIR001 for evaluation in the Phase 2 clinical trial Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF). The decision was made after previous evidence of AIR001’s potential benefit to patients with heart failure (HF) and preserved ejection fraction (pEF), an important measure of heart function.
San Diego-based Mast Therapeutics, a biopharma company developing clinical products under its Molecular Adhesion and Sealant Technology (MAST) platform, is currently developing Vepoloxamer, its lead product candidate, for the treatment of vaso-occlusive crisis in patients with sickle cell disease and also for the treatment of patients with chronic heart failure. Furthermore, the company is also developing a new investigational drug for the treatment of patients with heart failure with preserved ejection fraction (HFpEF), called AIR001.
AIR001 is a sodium nitrite solution for inhalation via nebulization. Nitrite is a vasodilator that can be recycled in vivo to form nitric oxide (NO), an event that has many beneficial effects such as blood vessel dilation and inflammation reduction. In previous clinical studies, the drug showed potential in reducing right atrial, pulmonary capillary and pulmonary artery pressures, as well as cardiac output and exercise tolerance, as measured by the six-minute walk distance test.
HFN’s main goal is to select treatments and drugs with clinical potential and conduct clinical trials to evaluate their efficacy in the management of acute and chronic heart failure. AIR001 was recently selected to be the subject of a 100-patient, multicenter, randomized, placebo-controlled Phase 2 clinical trial, the INDIE-HFpEF study. While HFN provides the platform for the study to be conducted, Mast Therapeutics will provide the test materials, nebulizers, and regulatory, technical and additional financial support. The company will also assist in the submission of an institutional Investigational New Drug application.
“We appreciate the HFN’s recognition of the study of AIR001 in heart failure as an appropriate area of investigation and the opportunity to work with them,” Brian M. Culley, CEO of Mast Therapeutics, said in a press release. “With their help, we expect to accelerate efforts to define the potential efficacy of AIR001 and hopefully provide a viable and much-needed treatment option for patients who have heart failure with preserved ejection fraction, as currently there are no proven effective therapeutic agents available for this large patient population.”