Aerovate Therapeutics to Present at Cowen 43rd Annual Health Care Conference
02 Março 2023 - 10:00AM
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 that Company management
will participate in a panel discussion at the Cowen 43rd Annual
Health Care Conference on Wednesday, March 8, at 10:30 a.m. ET. The
panel discussion will focus on respiratory diseases, including
pulmonary arterial hypertension (PAH), the recent sotatercept phase
3 data, and an overview of AV-101 and the IMPAHCT Phase 2b/Phase 3
trial.
A webcast of the corporate panel discussion 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 anti-proliferative drug imatinib. Developed
specifically for pulmonary arterial hypertension (PAH), AV-101
targets the abnormal smooth muscle cellular hyperproliferation in
the distal pulmonary arteries, caused by an imbalance of activity
between growth factors and apoptosis. 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 presented at the 2022 American Thoracic Society
(ATS) annual meeting 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 different doses 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.
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 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 release of topline data from the Phase 2b portion of our
clinical trial; our expectations regarding the strength of our
intellectual property portfolio globally; 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 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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