Business
Aerovate Therapeutics Announces Initiation of IMPAHCT Phase 2b/Phase 3 Trial of AV-101 In Pulmonary Arterial Hypertension
WALTHAM, Mass., Dec. 15, 2021 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing
About this update from Jade Biosciences, Inc.
[{"type":"text","content":"WALTHAM, Mass., Dec. 15, 2021 (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 diseases, today announced the initiation of its Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) Phase 2b/Phase 3 trial to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in adult patients with Pulmonary Arterial Hypertension (PAH). “There is a real need for new treatment options for PAH patients that work differently from our currently approved therapies,” said Dr. Nicholas Hill, Chief, Pulmonary, Critical Care and Sleep Division, Tufts Medical Center and Chair of the IMPAHCT clinical advisory board. “Imatinib has shown promise as a therapy for PAH and if AV-101 can deliver improvements for patients with fewer of the systemic adverse events associated with oral imatinib in PAH, it could represent a real advancement for patients.” “We are excited and humbled to initiate this Phase 2b/Phase 3 trial of AV-101,” said Tim Noyes, Chief Executive Officer at Aerovate. “Starting enrollment represents an important milestone for Aerovate Therapeutics and advances our goal of improving the lives of patients suffering from rare cardiovascular diseases.” Aerovate expects to report top-line results from the Phase 2b portion of IMPAHCT in mid-2023. More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT05036135. About the IMPAHCT TrialIMPAHCT is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with pulmonary arterial hypertension (PAH) that will continuously enroll patients as the study progresses from Phase 2b to Phase 3. The Phase 2b portion of the trial will evaluate three doses of AV-101 compared to placebo to identify an optimal dose based on the primary endpoint, change in pulmonary vascular resistance (PVR) over 24 weeks versus placebo, and safety, tolerability, and other clinical measures. The Phase 3 portion of the trial will compare patients taking the optimal dose selected in Phase 2b of AV-101 with placebo. The primary endpoint of the Phase 3 portion of the trial will be change in 6-minute walk distance (6MWD) over 24 weeks versus placebo. About Pulmonary Arterial Hypertension (PAH)Pulmonary ar...