Positive Interim Results From Phase 2 Study Of AIR001 In Patients With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction (PH-HFpEF) Published In Journal Of Clinical Investigation
In the 36 patients studied to date, administration of nebulized inhaled nitrite (AIR001) significantly decreased pulmonary, right atrial, and pulmonary capillary wedge pressures, and was most pronounced in patients with PH-HFpEF. AIR001 administration also led to a substantial increase in pulmonary artery compliance, which was most pronounced in patients with PH-HFpEF. AIR001 was generally well-tolerated and no significant safety concerns were identified, satisfying the primary safety outcome of the study. In addition, there were no significant decreases in peripheral oxygen saturation nor increases in methemoglobin levels above the stopping criteria of 5%.
"The results observed to date are important as they demonstrate that AIR001 can significantly lower right atrial pressures, pulmonary artery pressures, and pulmonary artery occlusion pressures, as well as improve pulmonary artery compliance," stated
"These data are consistent with results we saw in a separate investigator-sponsored Phase 2 study of AIR001 in HFpEF earlier this year and serve as a further step in validating AIR001 and establishing its potential clinical utility in HFpEF," stated
Of the 36 patients enrolled, 10 were diagnosed with PH-HFpEF, 20 were diagnosed with
Further analysis of the dose effect of AIR001 found that most hemodynamics were affected in a dose dependent manner with the exception of pulmonary artery compliance. There was a significant dose effect on right atrial pressure, mean pulmonary artery pressure, and pulmonary capillary wedge pressure. Cardiac index decreased in a dose-dependent manner. The increase in pulmonary artery compliance was not dose related.
About the Phase 2 Study
This is an institution-sponsored, single-center, open label Phase 2 study to evaluate the effect of AIR001 delivered in a dose escalation manner on the change in cardiovascular hemodynamics in subjects with PH who undergo standard right heart catheterization. The study will enroll a total of approximately 50 subjects with PH. Approximately 20 of the subjects will have a diagnosis of PH associated with HFpEF (
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 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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