Mast Therapeutics Announces Initiation Of Patient Enrollment In Additional Phase 2 Study Of AIR001 For The Treatment Of Heart Failure With Preserved Ejection Fraction
"We are pleased to report that patient enrollment is underway in this Phase 2 study of AIR001 for the treatment of HFpEF," stated
About the INABLE-TRAINING Study
This is a Phase 2 randomized, double-blind, parallel-group placebo-controlled clinical trial testing whether inhaled AIR001 (sodium nitrite solution), as compared to inhaled placebo, can enhance the benefits from chronic exercise training (ET) in subjects with HFpEF. All subjects will undergo 12 weeks of ET. Participants will be randomized to receive inhaled AIR001 three times daily or inhaled sodium chloride (placebo) three times daily during the study period. Study subjects will wear accelerometry devices to track daily activity levels at home. After 12 weeks of ET as part of standard cardiac rehab, subjects will repeat the assessment of cardiovascular function and exercise capacity as performed at study entry to assess efficacy at a final visit.
The Phase 2 study has 2 aims. First, determine whether treatment with inhaled AIR001 in addition to ET for 12 weeks improves exercise capacity and hemodynamic reserve in HFpEF. Expired gas analysis, inert gas (C2H2) rebreathe, and echocardiography will be performed during rest and exercise to measure oxygen consumption (VO2), CO, and hemodynamics before and after completion of 12 weeks of ET with inhaled NO2- vs ET with inhaled placebo. Second, determine whether treatment with inhaled AIR001 in addition to ET for 12 weeks increases daily activity levels and quality of life (QOL), and reduces symptoms of effort intolerance during ET. Subjects will use externally worn accelerometer devices to track daily physical activity. Tolerability of ET will be assessed by Borg perceived effort and dyspnea scores. Large and small vessel endothelial function (brachial and digital arteries) and QOL will also be assessed. Secondary endpoints include cardiac output reserve, peak exercise workload, rest and exercise hemodynamics assessed by echocardiography, Borg dyspnea and fatigue scores recorded during ET, endothelial function assessed by tonometry and brachial artery flow mediated dilation, QOL assessed by the Kansas City Cardiomyopathy Questionnaire. (ClinicalTrials.gov Identifier: NCT02713126)
AIR001 is a sodium nitrite solution for intermittent inhalation via nebulization. Nitrite is a direct vasodilator and can be recycled in vivo to form nitric oxide (NO) independent of the classical NO synthase (NOS) pathway. Nitrite mediated NO formation has several beneficial effects, including dilation of blood vessels and reduction of inflammation and undesirable cell growth. Generation of NO from sodium nitrite is not dependent upon endothelial function and is enhanced in the setting of tissue hypoxia and acidosis, conditions in which NOS activity typically is depressed. In early clinical studies, AIR001 demonstrated positive hemodynamic effects with reductions observed in right atrial pressure and pulmonary capillary wedge pressure, as well as improvements in mean pulmonary artery pressures, cardiac output, and exercise tolerance as measured by six-minute walk distance. In a randomized, double-blind, placebo-controlled Phase 2a study of AIR001 in patients with heart failure with preserved ejection fraction (HFpEF) (n=26), the AIR001 treatment group showed a statistically significant decrease in pulmonary capillary wedge pressure during exercise compared to the control group and AIR001 was generally well-tolerated.
Forward Looking Statements
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