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 presents results from a series of
studies in nonclinical species assessing the pharmacokinetics of
different formulations of imatinib at the American Thoracic Society
(ATS) 2023 International Conference in Washington, D.C. Aerovate is
developing inhaled imatinib as AV-101 for the treatment of
pulmonary arterial hypertension (PAH). While oral imatinib has
previously demonstrated clinically significant efficacy in PAH
patients in the global Phase 3 IMPRES trial conducted by Novartis,
the oral formulation was poorly tolerated due to adverse events.
“The results from these nonclinical studies further support our
development of AV-101, a dry powder formulation of imatinib
administered by inhalation for the treatment of PAH,” said Ralph
Niven, Ph.D., Chief Scientific Officer at Aerovate Therapeutics.
“Direct pulmonary delivery of imatinib demonstrates greater lung
and lower systemic exposure than can be achieved with oral
imatinib.”
The studies investigated the pharmacokinetics of imatinib in
nonclinical models, including mice, rats, and cynomolgus monkeys,
following delivery of imatinib formulations directly into the lungs
compared to other routes of administration. Data showed that lung
exposure in mice and rats following dry powder inhaled delivery was
substantially higher versus oral delivery, and the dry powder
formulation of imatinib enhanced lung exposure in rats over direct
delivery of suspension or solution, and improved lung exposure
versus oral or intravenous delivery. Repeat dosing of dry powder
aerosol to rats and monkeys also suggested concentrations were
maintained in the lungs after 24 hours. Measurements of the active
imatinib metabolite, N-desmethyl imatinib, showed no apparent
contribution to imatinib metabolism arising from the lungs. Plasma
time course profiles of imatinib after direct dry powder or
suspension dosing in rats were indicative of dissolution-controlled
absorption. These nonclinical results suggest that the AV-101
formulation and inhaled delivery of imatinib can enhance lung
exposure at a lower dose versus oral administration.
A previous Phase 1 study of AV-101 in healthy volunteers
demonstrated significantly lower systemic exposure compared to oral
imatinib. AV-101 was generally well-tolerated, suggesting that
lower systemic exposure can potentially decrease the side-effects
associated with oral imatinib for the treatment of PAH.
Aerovate continues to enroll IMPAHCT, a multi-national,
placebo-controlled Phase 2b/Phase 3 trial that is evaluating the
safety and efficacy of AV-101 in adults with PAH. Aerovate expects
to report topline data from the Phase 2b portion of the trial in
the second quarter of 2024.
A copy of the conference poster presentation will be available
in the “Presentations & Events” section of Aerovate’s website
at ir.aerovatetx.com.
Session: B59 – Union Square: Breaking Bad: New
Drugs and Formulations for Pulmonary Hypertension and RV
FailurePoster: The Influence of Route of Delivery
and Formulation on the Pulmonary Pharmacokinetics of Imatinib in
Nonclinical SpeciesPoster number:
P220Presenting author: Ralph Niven,
Ph.D.Date: May 22, 2023Time:
11:30am – 1:15pm ET
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 PAH
PAH is a rare, progressive orphan disease with unmet medical
need that affects approximately 70,000 people in the United States
and Europe. PAH can cause strain on the heart, leading to
limitation of physical activity, heart failure and reduced life
expectancy.
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,”
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 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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