Aerovate Therapeutics has announced that its pulmonary arterial hypertension (PAH) candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial. The Phase IIb portion of the IMPAHCT trial aimed to assess three different doses of AV-101, a novel dry powder inhaled formulation of imatinib. The primary endpoint tested change in pulmonary vascular resistance (PVR) compared to placebo, but none of the doses showed a significant benefit on this measure, and there was no meaningful improvement on the secondary endpoint evaluating how far patients could walk in six minutes.
As a result of the setback, the company is halting enrollment and shutting down the Phase III portion of IMPAHCT as well as the long-term extension study of AV-101.
Read more at this link on the Aerovate Therapeutics LinkedIn page