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Aerovate Therapeutics Presents Nonclinical Pharmacokinetic Data in Support of AV-101, a Novel Dry Powder Inhaled Formulation of Imatinib, at the American Thoracic Society (ATS) 2023 International Conference
Direct delivery of imatinib to the lungs in nonclinical species demonstrated increased lung exposure compared with oral or IV dosing Formulation impacted lung
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[{"type":"text","content":"Direct delivery of imatinib to the lungs in nonclinical species demonstrated increased lung exposure compared with oral or IV dosing Formulation impacted lung exposure with dry powder demonstrating greater lung exposure than suspension or solution and greater lung exposure vs oral or IV delivery The potential for a novel dry powder formulation of inhaled imatinib (AV-101), to lower the human dose necessary for an improved therapeutic profile in the treatment of pulmonary arterial hypertension is being explored in the currently recruiting IMPAHCT Phase 2b / Phase 3 trial WALTHAM, Mass., May 22, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today presents results from a series of studies in nonclinical species assessing the pharmacokinetics of different formulations of imatinib at the American Thoracic Society (ATS) 2023 International Conference in Washington, D.C. Aerovate is developing inhaled imatinib as AV-101 for the treatment of pulmonary arterial hypertension (PAH). While oral imatinib has previously demonstrated clinically significant efficacy in PAH patients in the global Phase 3 IMPRES trial conducted by Novartis, the oral formulation was poorly tolerated due to adverse events. “The results from these nonclinical studies further support our development of AV-101, a dry powder formulation of imatinib administered by inhalation for the treatment of PAH,” said Ralph Niven, Ph.D., Chief Scientific Officer at Aerovate Therapeutics. “Direct pulmonary delivery of imatinib demonstrates greater lung and lower systemic exposure than can be achieved with oral imatinib.” The studies investigated the pharmacokinetics of imatinib in nonclinical models, including mice, rats, and cynomolgus monkeys, following delivery of imatinib formulations directly into the lungs compared to other routes of administration. Data showed that lung exposure in mice and rats following dry powder inhaled delivery was substantially higher versus oral delivery, and the dry powder formulation of imatinib enhanced lung exposure in rats over direct delivery of suspension or solution, and improved lung exposure versus oral or intravenous delivery. Repeat dosing of dry powder aerosol to ra...