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Aerovate Therapeutics Presents Phase 1 Data for AV-101, A Novel Dry Powder Inhaled Formulation of Imatinib Being Developed for the Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
AV-101 is being developed to address cellular hyperproliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the
About this update from Jade Biosciences, Inc.
[{"type":"text","content":"AV-101 is being developed to address cellular hyperproliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the pathophysiology of PAH PAH is an area of high unmet need, and currently approved therapies are limited by acting primarily through vasodilation These Phase 1 results show that AV-101 delivered by dry powder inhalation was generally well tolerated and significantly reduced systemic exposure compared with oral imatinib in healthy adult participants WALTHAM, Mass., May 16, 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 presents Phase 1 results at the American Thoracic Society (ATS) International Conference in San Francisco. Aerovate’s data show that AV-101, a novel inhaled dry powder formulation of imatinib, was generally well-tolerated by healthy adult volunteers with no serious adverse events reported. “We are pleased these Phase 1 data showed that AV-101 was generally well-tolerated in this trial of healthy adult volunteers across a dose range we believe may overlap or exceed lung exposures from 400 mg of oral imatinib, the dose used in the Novartis global Phase 3 IMPRES trial, while simultaneously reducing systemic exposure,” said Timothy Noyes, Chief Executive Officer at Aerovate. “These findings represent an important step forward in our clinical development of AV-101, and support the selection of doses being evaluated in our ongoing Phase 2b/Phase 3 IMPAHCT trial.” Imatinib 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 oral imatinib for PAH was discontinued. Aerovate designed AV-101, a dry powder inhaled formulation of imatinib, to target imatinib’s anti-proliferative activity in the pulmonary vasculature by direct delivery to the lungs while potentially avoiding the treatment-limiting systemic toxicities seen with oral imatinib. Aerovate’s Phase 1 trial evaluated single and multiple ascending doses of AV-101 administered by inhalation for safety, tolerability, and pharmacokinetics...