Aerovate completes enrollment for Phase 2b portion of IMPAHCT study

Aerovate Therapeutics announced the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial, or IMPAHCT, Phase 2b/Phase 3 study evaluating AV-101, a novel dry powder inhaled formulation of imatinib for the treatment of pulmonary arterial hypertension, or PAH, has completed enrollment at 202 adult patients. Aerovate expects to report topline data from the Phase 2b portion of the trial in June 2024. In addition, the first patient has been enrolled in the Phase 3 portion of IMPAHCT. IMPAHCT is a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled multi-national trial evaluating the safety, efficacy, tolerability, pharmacokinetics (PK) and pharmacodynamics of AV-101 in adults with PAH. The IMPAHCT trial was structured with a seamless adaptive Phase 2b/Phase 3 design to allow for an efficient development timeline, thus enabling the immediate enrollment of patients in the Phase 3 portion of the study upon the completion of enrollment in the Phase 2b portion. Currently, more than 120 sites are open and actively recruiting patients in the Phase 3 portion of the trial. The Phase 2b primary endpoint of IMPAHCT is the placebo corrected change from baseline in pulmonary vascular resistance (PVR). Following the results of the Phase 2b portion of the study, an optimal dose will be selected and all subsequent patients enrolled in IMPAHCT will be randomized to either placebo or the optimal dose. The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance after 24 weeks of treatment with the optimal dose.