Aerovate Says Phase 2b Portion Of Trial Of AV-101 Fails To Meet Primary And Secondary Endpoints
(RTTNews) - Biopharmaceutical company Aerovate Therapeutics, Inc. (AVTE) announced Monday topline results from the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial of AV-101.
AV-101 is a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH).
The objective of the Phase 2b portion of IMPAHCT was to assess the efficacy, safety and tolerability of three different doses of AV-101 compared to placebo. The primary endpoint for the Phase 2b portion of IMPAHCT is change in pulmonary vascular resistance (PVR) compared with placebo.
In this portion of the trial, AV-101 was well tolerated across all dose groups, but the study did not meet its primary endpoint for improvement in PVR compared to placebo for any of the studied doses or show meaningful improvements in the secondary endpoint of change in six minute walk distance (6MWD).
The Company has also reviewed data from several additional secondary endpoints of the Phase 2b portion of IMPAHCT, which also failed to show meaningful improvements.
Based upon these results, Aerovate, in agreement with the independent study advisory committee, is halting enrollment and shutting down the Phase 3 portion of IMPAHCT as well as the long-term extension study.
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