Aerovate Therapeutics Announces Initiation of IMPAHCT Phase 2b/Phase 3 Trial of AV-101 In Pulmonary Arterial Hypertension
16 December 2021 - 12:00AM
Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage
biopharmaceutical company focused on developing drugs that
meaningfully improve the lives of patients with rare
cardiopulmonary diseases, today announced the initiation of its
Inhaled I
matinib
Pulmonary
Arterial
Hypertension
Clinical
Trial (IMPAHCT) Phase 2b/Phase 3 trial to evaluate
the safety and efficacy of AV-101 (dry powder inhaled imatinib) in
adult patients with Pulmonary Arterial Hypertension (PAH).
“There is a real need for new treatment options for PAH patients
that work differently from our currently approved therapies,” said
Dr. Nicholas Hill, Chief, Pulmonary, Critical Care and Sleep
Division, Tufts Medical Center and Chair of the IMPAHCT clinical
advisory board. “Imatinib has shown promise as a therapy for PAH
and if AV-101 can deliver improvements for patients with fewer of
the systemic adverse events associated with oral imatinib in PAH,
it could represent a real advancement for patients.”
“We are excited and humbled to initiate this Phase 2b/Phase 3
trial of AV-101,” said Tim Noyes, Chief Executive Officer at
Aerovate. “Starting enrollment represents an important milestone
for Aerovate Therapeutics and advances our goal of improving the
lives of patients suffering from rare cardiovascular diseases.”
Aerovate expects to report top-line results from the Phase 2b
portion of IMPAHCT in mid-2023.
More information about this trial is available at
https://clinicaltrials.gov/ct2/show/NCT05036135.
About the IMPAHCT TrialIMPAHCT is a
multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults
with pulmonary arterial hypertension (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 compared to placebo to identify an optimal dose based on the
primary endpoint, change in pulmonary vascular resistance (PVR)
over 24 weeks versus placebo, and safety, tolerability, and other
clinical measures. The Phase 3 portion of the trial will compare
patients taking the optimal dose selected in Phase 2b of AV-101
with placebo. The primary endpoint of the Phase 3 portion of the
trial will be change in 6-minute walk distance (6MWD) over 24 weeks
versus placebo.
About Pulmonary Arterial Hypertension
(PAH)Pulmonary arterial hypertension (PAH) is a rare,
progressive disease characterized by cellular hyperproliferation of
the pulmonary vasculature that affects approximately 70,000 people
in the United States and Europe. The disease process involves
remodeling, constriction and occlusion of the small pulmonary
arteries resulting in elevated blood pressure in the pulmonary
circulation. PAH can cause strain on the heart, leading to
limitation of physical activity, heart failure and reduced life
expectancy. Existing vasodilator drugs fail to treat the underlying
cellular proliferation causing the disease.
About AV-101AV-101 is a proprietary dry powder
inhaled formulation of the anti-proliferative drug imatinib. Dosed
specifically for PAH, 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. In a
recent Phase 1 clinical trial, AV-101 was generally well-tolerated
by healthy adult volunteers with no serious adverse events
associated with AV-101.
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 diseases. Aerovate's initial focus is on advancing
AV-101, its dry powder inhaled formulation of the drug imatinib for
the treatment of PAH.
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,”
“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 of AV-101; our
expectations regarding patient enrollment for the Phase 2b portion
of our Phase 2b/Phase 3 trial of AV-101 in PAH; our business plans
and objectives for AV-101, including expectations regarding timing
and success of the our Phase 2b/Phase 3 clinical trial, including
the timing of top-line results, the therapeutic potential and
clinical benefits of AV-101 and 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 of AV-101, and
the timing associated with patient recruitment, initiation and
continuation of our Phase 2b/Phase 3 trial of AV-101 in PAH
patients and timing of top-line results, 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,
and other risks identified in our filings with the Securities and
Exchange Commission (“SEC”), including our Registration Statement
on Form S-1, 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.
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