Top Line Results From Aironite Phase 2 Clinical Trial for the Treatment of HFpEF to Be Presented at American College of Cardiology 67th Annual Scientific Sessions & Expo on March 11th
The 100-patient study, known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study, was sponsored by
About the INDIE-HFpEF Study
The INDIE-HFpEF study was a multicenter, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of Aironite on peak exercise capacity as assessed by cardiopulmonary exercise testing (CPET). The study was sponsored and conducted by the HFN, and Savara's wholly-owned subsidiary,
Aironite is a sodium nitrite solution for inhalation via nebulization in Phase 2 clinical trials in patients with HFpEF. 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 and Nitrite-mediated NO formation have multiple beneficial effects, including dilation of blood vessels, reduction in hemodynamic perturbations during exercise in the failing heart, and improvements in skeletal muscle bioenergetics and mitochondrial respiration, resulting in improved efficiency of oxygen utilization during submaximal exercise.
In addition to the INDIE-HFpEF study, Savara is also supporting a complementary, double blind, placebo-controlled institution-sponsored Phase 2 study of Aironite in patients with HFpEF, referred to as the INABLE study. The main objective of the INABLE study is to assess the efficacy of Aironite on the same outcome measures as in the INDIE-HFpEF study, but when used in conjunction with supervised cardiac rehabilitation exercise training. Supervised exercise training for HFpEF patients is the only therapeutic intervention to have demonstrated improvements in exercise capacity and quality of life in patients managed with nonspecific heart failure medications, thus the INABLE study is designed to demonstrate Aironite's ability to amplify this benefit.
About the Heart Failure Clinical Research Network (HFN)
The HFN was established by the National Heart, Lung, and
Forward Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements about the expected release of top-line results from the INDIE-HFpEF study, that nitrite and nitrite NO formulation have multiple beneficial effects, that the INABLE study is designed to demonstrate Aironite's ability to amplify this benefit and Savara's strategy. Savara may not actually achieve any of the matters referred to in such forward looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the outcome of our ongoing clinical trials for Aironite and our other product candidates, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidates in a timely manner, the timing and ability of Savara to raise additional equity capital to fund continued operations; the ability to successfully develop Aironite and our other product candidates, and the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex, AeroVanc and Aironite that are safe and effective for use as human therapeutics. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the
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