Aerovate Therapeutics to Present at Jefferies Global Healthcare Conference
01 June 2023 - 10:00PM
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 that Company management
will present at the Jefferies Global Healthcare Conference on
Wednesday, June 7, at 8:00 a.m. ET, which presentation will include
an overview of AV-101 and the IMPAHCT Phase 2b/Phase 3 trial.
A webcast of the conference presentation will be
available in the “Events & Presentations” section of Aerovate’s
website at www.AerovateTx.com.
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 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 is enrolling patients in
the IMPAHCT Phase 2b/Phase 3 clinical trial to evaluate the safety
and efficacy of AV-101 in adults with PAH.
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
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 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 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 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 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 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,”
“potential,” 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 therapeutic potential, tolerability and
clinical benefits of AV-101; our expectations regarding clinical
site activation and patient enrollment for our Phase 2b/Phase 3
trial; our anticipated timing for the completion of enrollment and
release of topline data from the Phase 2b portion of our clinical
trial; our business plans and objectives for AV-101, including
expectations regarding timing and success of our Phase 2b/Phase 3
clinical trial, potential regulatory submissions and approvals for
AV-101; and our growth and goals as a company.
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, tolerability 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 the COVID-19
pandemic 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
Contactinfo@aerovatetx.com
Investor
Contactir@aerovatetx.com
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