Baseline characteristics reflect a PAH population with significant disease
Topline data from Phase 2b portion of IMPAHCT study to be released in
Enrollment into the Phase 3 portion of IMPAHCT continues at more than 120 sites globally
“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
The 202 adult patients in the Phase 2b portion of IMPAHCT are roughly split between
“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
Aerovate expects to present topline Phase 2b data in June and continue Phase 3 trial enrollment globally. A copy of the conference poster presentation will be available in the “Events & Presentations” section of Aerovate’s website at ir.aerovatetx.com.
About PAH
PAH is a rare, progressive orphan disease with unmet medical need that affects approximately 70,000 people in
About AV-101
AV-101 is an investigational, proprietary dry powder inhaled formulation of the antiproliferative drug imatinib. Developed specifically for pulmonary arterial hypertension (PAH), AV-101 is designed to target cellular hyperproliferation and resistance to apoptosis, driven by improper signaling in cells of the distal pulmonary arteries. By targeting the proliferation and accumulation of cells in the arteries of the lungs, we believe AV-101 has the potential to provide meaningful improvements for patients beyond the capabilities of currently approved therapies. AV-101 is designed for delivery by an easy-to-use dry powder inhaler, directly into the lungs to maximize potential clinical benefit and limit systemic adverse effects. Phase 1 results published in
About the IMPAHCT Trial
IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with PAH that continuously enrolled patients from Phase 2b to Phase 3. The Phase 2b portion of the trial will evaluate three doses of AV-101 over 24 weeks, compared to placebo, to identify an optimal dose based on the primary endpoint, change in pulmonary vascular resistance (PVR), and safety, tolerability, and other clinical measures. The Phase 3 portion of the trial will compare patients taking the optimal dose of AV-101, selected from the Phase 2b data, to placebo. The primary endpoint of the Phase 3 portion of the trial will be change in six-minute walk distance (6MWD) over 24 weeks versus placebo. More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT05036135.
About
Aerovate is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. Aerovate's initial focus is on advancing AV-101, its proprietary dry powder inhaled formulation of the drug imatinib for the treatment of patients with PAH. Learn more at aerovatetx.com or follow the Company on X (formerly known as Twitter) and LinkedIn.
Available Information
Aerovate announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “future,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” seek,” “strategy,” “should,” “target,” “will,” “would” and similar expressions regarding future periods. These forward-looking statements include, but are not limited to, statements regarding the baseline patient characteristics from the Phase 2b portion of the IMPAHCT trial and contribution of those characteristics to the evaluation of safety and efficacy measures; the clinical significance of similarities in baseline characteristics of patients in IMPAHCT as compared to prior-conducted trials, including third-party trials; our expectations regarding continuing patient enrollment for the Phase 3 portion of the IMPAHCT trial; therapeutic potential and clinical benefits of AV-101; and our anticipated timing for the release of topline data from the Phase 2b portion of the IMPAHCT trial.
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, safety 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; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in
Media Contact
peg.rusconi@vergescientific.com
Investor Contact
IR@Aerovatetx.com
![](https://ml.globenewswire.com/media/NDQ5MWE4NDUtMmYwMi00ZThkLTkxNzUtMTlhNDhmZTdlNDlhLTEyMjA3ODk=/tiny/Aerovate-Therapeutics-Inc-.png)
2024 GlobeNewswire, Inc., source