Aerovate Therapeutics to Present Patient Baseline Characteristics of the Phase 2b Portion of the Phase 2b/Phase 3 IMPAHCT Trial at the American Thoracic Society 2024 International Conference
March 27 2024 - 8:20AM
Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage
biopharmaceutical company focused on developing drugs that improve
the lives of patients with rare cardiopulmonary disease, today
announced an upcoming poster presentation at the 2024 American
Thoracic Society (ATS) International Conference taking place May
17-22, 2024, in San Diego, CA. The presentation will provide
baseline characteristics from patients enrolled in the dose-ranging
Phase 2b portion of the
Inhaled
i
Matinib
Pulmonary
Arterial
Hypertension
Clinical
Trial (IMPAHCT), a Phase
2b/Phase 3, randomized, double-blind, placebo-controlled,
multi-national trial evaluating the safety and efficacy of AV-101
in adults with pulmonary arterial hypertension.
“We look forward to presenting baseline characteristics of the
Phase 2b portion of the IMPAHCT trial in our poster presentation at
the upcoming ATS conference in May,” said Tim Noyes, Chief
Executive Officer at Aerovate Therapeutics. “These data will
provide insight into the IMPAHCT patient population as we continue
Phase 3 trial recruitment globally and expect to present top line
Phase 2b data in June.”
Details for the poster presentation are as follows:
Poster Session: C62. Top Gun: Novel
Therapeutics And Outcomes In Pulmonary Arterial Hypertension
Date: Tuesday, May 21, 2024Presentation
Time: 11:30 a.m. – 1:15 p.m. PTLocation:
Session Room TDP29Abstract: Baseline
characteristics from the IMPAHCT trial of AV-101, inhaled imatinib,
in subjects with pulmonary arterial
hypertensionPresenter: Hunter Gillies, MBChB
The poster abstract is available now on the 2024 ATS website.
The abstract includes data from 147 patients, and the poster
presentation on May 21st will include baseline characteristics for
all 202 Phase 2b patients.
About AV-101AV-101 is an investigational,
proprietary dry powder inhaled formulation of the antiproliferative
drug imatinib. Developed specifically for pulmonary arterial
hypertension (PAH), AV-101 targets 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 ERJ Open Research showed that AV-101 delivered by dry
powder inhalation was generally well-tolerated by healthy adult
volunteers with no serious adverse events reported. Aerovate has
completed enrollment in the Phase 2b portion of the IMPAHCT
clinical trial and is currently enrolling patients in the Phase 3
portion to evaluate the safety and efficacy of AV-101 in adults
with PAH.
About the IMPAHCT TrialIMPAHCT (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 Therapeutics, Inc.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 InformationAerovate 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 U.S. Securities and Exchange Commission
(SEC), press releases, public conference calls, webcasts, the
investor relations section of the Company website at
ir.aerovatetx.com, and the Company’s X (formerly known as Twitter)
account @AerovateTx in order to achieve broad, non-exclusionary
distribution of information to the public and for complying with
its disclosure obligations under Regulation FD.
Cautionary Note Regarding Forward-Looking
StatementsThis 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; our expectations regarding continuing patient
enrollment for the Phase 3 portion of the IMPAHCT trial; and our
anticipated timing for the release of topline data from the Phase
2b portion of our clinical 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 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.
Media ContactPeg
Rusconipeg.rusconi@vergescientific.com
Investor ContactIR@Aerovatetx.com
Aerovate Therapeutics (NASDAQ:AVTE)
Historical Stock Chart
From May 2024 to Jun 2024
Aerovate Therapeutics (NASDAQ:AVTE)
Historical Stock Chart
From Jun 2023 to Jun 2024