Aires Pharmaceuticals has signed an agreement with Duke University, US, to provide support for a Phase 2 clinical study of the company's AIR001 product in patients with heart failure with preserved ejection fraction (HFpEF).
Aires is a fully owned subsidiary of biopharmaceutical company Mast Therapeutics.
The multicentre, randomised, double-blind, placebo-controlled study, known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study, will be conducted on 100 patients.
INDIE-HFpEF will be sponsored by Duke Clinical Research Institute (DCRI), which is a part of Duke University School of Medicine, as the coordinating centre for the Heart Failure Clinical Research Network (HFN), established by National Heart, Lung, and Blood Institute (NHLBI), Maryland, US.
The study will be conducted at around 20 clinical centres, which are part of HFN, in the US.
INDIE-HFpEF's primary endpoint will be the peak oxygen consumption (VO2) after four weeks of treatment with nebulised inhaled AIR001 or placebo as assessed by CPET performed at peak drug levels.
Secondary objectives of the study cover evaluation of whether AIR001 improves submaximal activity tolerance chronically, quality of life and chronic filling pressures as assessed by echocardiography and natriuretic peptide levels.
The objectives also include ventilator efficiency or submaximal exercise capacity at peak drug levels, and evaluation of the safety and tolerability of AIR001.
Under a previous agreement with the HFN Coordinating Centre, Mast Therapeutics will provide test materials, nebulisers, and regulatory, technical and additional financial support to the proposed study.
Mast Therapeutics said that HFpEF is a usual form of heart failure that has not responded, as well to previously tested treatments as heart failure with reduced ejection fraction.
AIR001 is a sodium nitrite solution that is given in intermittent inhalation via nebulisation, and was acquired by Mast Therapeutics in 2014 through the purchase of then privately held Aires Pharmaceuticals.
The company recently documented positive results from a blinded and randomised Phase 2a clinical study of AIR001 in 30 patients with HFpEF conducted at Mayo Clinic.