Aerovate Therapeutics Publishes Results of Phase 1 Study Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension in ERJ Open Research

Phase 1 results showed that AV-101 was generally well tolerated with significantly reduced systemic exposure compared to oral imatinib in healthy adult participants

Excerpt from the Press Release:

WALTHAM, Mass., Nov. 17, 2022 (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 announced the publication of Phase 1 study results evaluating AV-101, a novel dry powder inhaled formulation of imatinib, in ERJ Open Research. The results showed that AV-101 was generally well tolerated and inhaled administration significantly reduced systemic exposure compared to orally dosed imatinib with no serious adverse events reported. AV-101 is being developed to address abnormal cellular proliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the pathophysiology of pulmonary arterial hypertension (PAH).

Imatinib is an anti-proliferative drug initially approved for the treatment of chronic myeloid leukemia. It has previously demonstrated a statistically significant and clinically meaningful benefit in PAH patients in the global Phase 3 IMPRES trial, conducted by Novartis, when administered orally as a tablet but was poorly tolerated due to adverse events. The development of imatinib for PAH was discontinued. Aerovate designed AV-101 to deliver imatinib throughout the airways to more directly access the diseased blood vessels in the lung, at or above concentrations observed with the oral dose while limiting systemic exposure. This allows for the potential to maximize efficacy while limiting the adverse events observed with oral imatinib.

“Our objective was direct delivery of imatinib to the lung using lower doses to limit systemic exposure, and our Phase 1 findings demonstrate that inhaled AV-101 limited systemic exposure compared to oral imatinib and was generally well tolerated,” said Dr. Hunter Gillies, M.B.Ch.B., Chief Medical Officer at Aerovate and lead author. “There continues to be a high unmet need for new medications to treat PAH, and these results reaffirm our confidence in AV-101 as a potential option for people living with the condition. We look forward to further investigation of AV-101 in our Phase 2b/Phase 3 trial.”

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