Aerovate Therapeutics says that the Phase 2b portion of the Phase 2b/3 IMPAHCT trial of the company’s AV-101 inhaled dry powder imatinib in patients with pulmonary arterial hypertension (PAH) failed to meet its primary endpoint of change in pulmonary vascular resistance compared to placebo for any of the doses studied. The IMPAHCT trial was initiated in December 2021.
The trial also failed to meet secondary endpoints, demonstrating no significant change in six minute walk distance and other outcomes. As a result, the company says, it is shutting down the Phase 3 portion of the IMPAHCT trial, as well as a planned long-term extension study.
Aerovate CEO Tim Noyes commented, “The results of the Phase 2b portion of IMPAHCT were unexpected and disappointing. Our immediate focus is on transparently sharing these findings with investigators, patients and the PAH community. In the coming weeks, we will engage closely with the IMPAHCT study advisory committee and the PAH community to thoroughly discuss these data and their implications. We extend our heartfelt gratitude to all trial participants, investigators, and site teams for their dedication to advancing therapeutic options for the treatment of pulmonary arterial hypertension.”
Read the Aerovate press release.
