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AER-901 is an inhaled formulation of the tyrosine kinase inhibitor imatinib, specifically designed for the treatment of pulmonary arterial hypertension (PAH). Developed by Aerami Therapeutics, it is a drug-device combination that utilizes the FOX® vibrating mesh nebulizer to deliver the medication directly to the site of disease in the lungs. This approach aims to achieve high therapeutic concentrations in the pulmonary vasculature while minimizing the systemic side effects that limited the clinical utility of oral imatinib in previous PAH trials, such as the Phase 3 IMPRES study. AER-901 is intended to act as a reverse-remodeling therapy by inhibiting the proliferation of smooth muscle cells and fibroblasts, potentially addressing the underlying pathology of PAH rather than just providing symptomatic relief through vasodilation.
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