Aerovate Therapeutics Announces Simultaneous Completion of Enrollment in Phase 2b Portion and Enrollment of First Patient into Phase 3 in the IMPAHCT Trial Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension
Topline Phase 2b data expected in June 2024
More than 120 sites around the world actively recruiting in the Phase 3 portion of the IMPAHCT trial
WALTHAM, Mass., Nov. 20, 2023 (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 Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) Phase 2b/Phase 3 study evaluating AV-101, a novel dry powder inhaled formulation of imatinib for the treatment of pulmonary arterial hypertension (PAH), has completed enrollment at 202 adult patients. Aerovate expects to report topline data from the Phase 2b portion of the trial in June 2024. In addition, the first patient has been enrolled in the Phase 3 portion of IMPAHCT.
“The completion of enrollment in the Phase 2b portion of the trial marks an exciting milestone for Aerovate and for people living with PAH,” said Tim Noyes, Chief Executive Officer at Aerovate Therapeutics. “Because of our innovative adaptive Phase 2b/Phase 3 trial design for IMPAHCT, we were also able to rapidly enroll our first patient in the Phase 3 portion of the study evaluating our novel investigational antiproliferative drug candidate, AV-101, for the treatment of PAH. I am extremely grateful for the commitment of our clinical investigators and their patients, and proud of the Aerovate team’s dedication and ongoing execution of the trial, as this furthers our goal of developing meaningful therapeutic options for PAH patients as quickly as possible.”
IMPAHCT is a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled multi-national trial evaluating the safety, efficacy, tolerability, pharmacokinetics (PK) and pharmacodynamics of AV-101 in adults with PAH. The IMPAHCT trial was structured with a seamless adaptive Phase 2b/Phase 3 design to allow for an efficient development timeline, thus enabling the immediate enrollment of patients in the Phase 3 portion of the study upon the completion of enrollment in the Phase 2b portion. Currently, more than 120 sites are open and actively recruiting patients in the Phase 3 portion of the trial.
The Phase 2b primary endpoint of IMPAHCT is the placebo corrected change from baseline in pulmonary vascular resistance (PVR). Following the results of the Phase 2b portion of the study, an optimal dose will be selected and all subsequent patients enrolled in IMPAHCT will be randomized to either placebo or the optimal dose. The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment with the optimal dose.
AV-101, an investigational, proprietary dry powder inhaled formulation of imatinib, is being developed by Aerovate for the treatment of PAH, a rare, progressive disease which involves abnormal cellular proliferation and resistance to apoptosis in the pulmonary vasculature. AV-101 has been formulated for self-administration in which patients will perform two inhalations twice daily with a discreet, pocket-sized device designed for easy use.
About the IMPAHCT Trial
About Aerovate Therapeutics, Inc.
Cautionary Note Regarding Forward-Looking Statements
Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the therapeutic potential and clinical benefits of AV-101; the timing associated with the identification and activation of clinical sites, patient enrollment, initiation, delivery of drug supply and continuation of our Phase 2b/Phase 3 trial of AV-101 in PAH patients; the impact of public health crises on our business, clinical trials, operations and goals; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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