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 that its Board of Directors has elected current Board
member, Habib Dable, as Chair of the Board. Mr. Dable succeeds Mark
Iwicki, who will continue to serve on the Board.
“We are pleased to have Habib take on the role of Chair of the
Board,” said Tim Noyes, Chief Executive Officer of Aerovate
Therapeutics. “With the Phase 2b data readout from our global
IMPAHCT trial of AV-101 in PAH coming in June and our Phase 3 trial
already well underway, his leadership and deep expertise in drug
development and commercialization will be invaluable as we begin
building towards the future. I would also like to thank Mark for
his significant contributions and commitment to Aerovate, and I
look forward to continuing to work together.”
“I am honored to assume the role of Board Chair for Aerovate
during this exciting time for the company,” said Mr. Dable. “I look
forward to continuing to work with the team as Aerovate advances
AV-101 through the clinic and hopefully bringing us closer to
providing a potentially life-changing therapy to people living with
pulmonary arterial hypertension.”
With experience in both emerging biotech and late-stage
biopharmaceutical companies, Mr. Dable joined the Board of
Directors in July 2023. He also serves on the Boards of Blueprint
Medicines Corporation, Day One Biopharmaceuticals, Inc., and PepGen
Inc. and is a part-time Venture Partner at RA Capital Management,
L.P., having previously also served as a member of the Boards of
Directors of Albireo Pharm, Inc., Millendo Therapeutics Inc., and
the Biotechnology Innovation Organization (BIO). Mr. Dable
previously led Acceleron Pharma, Inc. as President and Chief
Executive Officer, eventually facilitating its $11.5 billion sale
to Merck & Co. in 2021. Earlier in his career, he worked at
Bayer AG where he held roles of increasing responsibility
ultimately serving as President of US Pharmaceuticals. During Mr.
Dable’s tenure at Bayer AG, he led the launches of several highly
successful brands, including EYLEA® as Global Head Neurology and
Ophthalmology, as well as Stivarga®, and Xofigo® as Global Head
Specialty Medicine.
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; and our
business plans and objectives for AV-101, including expectations
regarding timing and success of our Phase 2b/Phase 3 clinical trial
and 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
Aerovate Therapeutics (NASDAQ:AVTE)
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Aerovate Therapeutics (NASDAQ:AVTE)
過去 株価チャート
から 9 2023 まで 9 2024