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 the Phase 2b portion of
the
Inhaled i
Matinib
Pulmonary
Arterial
Hypertension
Clinical
Trial (IMPAHCT) Phase 2b/Phase 3 study evaluating
AV-101, a novel dry powder inhaled formulation of imatinib for the
treatment of pulmonary arterial hypertension (PAH), has completed
enrollment at 202 adult patients. Aerovate expects to report
topline data from the Phase 2b portion of the trial in June 2024.
In addition, the first patient has been enrolled in the Phase 3
portion of IMPAHCT.
“The completion of enrollment in the Phase 2b portion of the
trial marks an exciting milestone for Aerovate and for people
living with PAH,” said Tim Noyes, Chief Executive Officer at
Aerovate Therapeutics. “Because of our innovative adaptive Phase
2b/Phase 3 trial design for IMPAHCT, we were also able to rapidly
enroll our first patient in the Phase 3 portion of the study
evaluating our novel investigational antiproliferative drug
candidate, AV-101, for the treatment of PAH. I am extremely
grateful for the commitment of our clinical investigators and their
patients, and proud of the Aerovate team’s dedication and ongoing
execution of the trial, as this furthers our goal of developing
meaningful therapeutic options for PAH patients as quickly as
possible.”
IMPAHCT is a Phase 2b/Phase 3, randomized, double-blind,
placebo-controlled multi-national trial evaluating the safety,
efficacy, tolerability, pharmacokinetics (PK) and pharmacodynamics
of AV-101 in adults with PAH. The IMPAHCT trial was structured with
a seamless adaptive Phase 2b/Phase 3 design to allow for an
efficient development timeline, thus enabling the immediate
enrollment of patients in the Phase 3 portion of the study upon the
completion of enrollment in the Phase 2b portion. Currently, more
than 120 sites are open and actively recruiting patients in the
Phase 3 portion of the trial.
The Phase 2b primary endpoint of IMPAHCT is the placebo
corrected change from baseline in pulmonary vascular resistance
(PVR). Following the results of the Phase 2b portion of the study,
an optimal dose will be selected and all subsequent patients
enrolled in IMPAHCT will be randomized to either placebo or the
optimal dose. The Phase 3 primary endpoint will be the placebo
corrected change in 6-minute walk distance (6MWD) after 24 weeks of
treatment with the optimal dose.
AV-101, an investigational, proprietary dry powder inhaled
formulation of imatinib, is being developed by Aerovate for the
treatment of PAH, a rare, progressive disease which involves
abnormal cellular proliferation and resistance to apoptosis in the
pulmonary vasculature. AV-101 has been formulated for
self-administration in which patients will perform two inhalations
twice daily with a discreet, pocket-sized device designed for easy
use.
About PAHPAH 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 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 therapeutic potential and clinical benefits of AV-101; our
expectations regarding clinical sites and continuing patient
enrollment for the Phase 3 portion of our Phase 2b/Phase 3 trial;
our anticipated timing for the release of topline data from the
Phase 2b portion of our clinical trial; and 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.
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
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