AVTE - Aerovate Therapeutics Presents Baseline Data from the Phase 2b Portion of the IMPAHCT Trial at the American Thoracic Society 2024 International Conference | Benzinga
Baseline characteristics reflect a PAH population with significant disease
Topline data from Phase 2b portion of IMPAHCT study to be released in June 2024
Enrollment into the Phase 3 portion of IMPAHCT continues at more than 120 sites globally
WALTHAM, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (NASDAQ:AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today presented a poster outlining baseline characteristics from all patients enrolled in the dose-ranging Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) at the American Thoracic Society (ATS) 2024 International Conference taking place in San Diego, CA. IMPAHCT is a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multinational trial evaluating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension (PAH).
"These baseline characteristics reflect a patient population with significant disease despite treatment with two to three targeted PAH therapeutics. This underscores the unmet need for novel therapeutics with unique mechanisms of action that address the key drivers of PAH," said Hunter Gillies, MBChB, Chief Medical Officer of Aerovate Therapeutics. "Coupled with our operationally seamless and adaptive IMPAHCT Phase 2b/Phase 3 trial design, we believe we are well positioned to move AV-101 forward efficiently through Phase 3 development without compromising the scientific rigor required to optimize the dose of a new investigational drug for patients."
The 202 adult patients in the Phase 2b portion of IMPAHCT are roughly split between World Health Organization functional classes II and III, with approximately 57% of patients on triple background therapy consisting of prostacyclins, endothelin receptor antagonists, and nitric oxide pathway targeting compounds. The baseline characteristics are similar to other recent studies in PAH for novel therapeutics and should support the ability to evaluate clear signals of efficacy, safety and tolerability of AV-101, a novel dry powder formulation of imatinib administered by inhalation.
"We believe that we are at the beginning stages of a new era of therapeutics in PAH that have the potential to address the root cause of disease," said Tim Noyes, Chief Executive Officer of Aerovate Therapeutics. "Our previous Phase 1 study in healthy adult volunteers demonstrated that direct delivery of lower doses of imatinib to the lung through dry powder inhalation resulted in lower systemic exposure than achieved with 400mg of oral imatinib with no serious adverse events reported. We are looking forward to providing our Phase 2b data in June and advancing AV-101 development to provide a novel antiproliferative treatment for patients with ...