Aerovate Therapeutics has initiated a Phase 2b/3 trial of its AV-101 imatinib DPI for the treatment of pulmonary arterial hypertension (PAH), the company said. The IMPAHCT trial is expected to enroll 462 PAH patients; the Phase 2b portion of the trial will evaluate three doses of AV-101 versus placebo to select a dose for the Phase 3 portion. Topline results from the Phase 2b part of the study are expected in mid-2023.
In August 2020, Aerovate announced that it had launched with $72.6 million in Series A financing for development of the dry powder imatinib formulation for PAH. According to the company, a Phase 1 trial in healthy volunteers that was completed recently demonstrated that AV-101 was well tolerated with no serious adverse events.
Aerovate CEO Tim Noyes said, “We are excited and humbled to initiate this Phase 2b/Phase 3 trial of AV-101. Starting enrollment represents an important milestone for Aerovate Therapeutics and advances our goal of improving the lives of patients suffering from rare cardiovascular diseases.”
Read the Aerovate press release.
