LAVAL,
QC, June 22, 2023 /PRNewswire/ -- Acasti
Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a
late-stage, biopharma company advancing GTX-104, its novel
formulation of nimodipine that addresses the high unmet medical
needs for a rare disease, aneurysmal subarachnoid hemorrhage
(aSAH), today announced the appointment of W. Taylor Kimberly, MD, PhD, Alejandro A.
Rabinstein, MD and Sherry H-Y. Chou, MD to its Scientific Advisory
Board.
"We are extremely pleased to add eminent physicians with a deep
understanding of aSAH and neurocritical care to the Acasti
Scientific Advisory Board," commented Prashant Kohli, CEO of Acasti. "As we continue
to focus our efforts squarely on the advancement GTX-104, a
critically important drug candidate for the thousands of patients
who suffer from subarachnoid hemorrhage without effective treatment
options, Drs. Kimberly, Rabinstein and Chou will offer unmatched
insight into this indication."
Acasti announced in May 2023 the
successful submission to the FDA of GTX-104's full protocol of its
pivotal Phase 3 Safety Study for what it believes will be the final
clinical step required to seek FDA approval under the 505(b)(2)
regulatory pathway with expectation for first patient dosed in
calendar Q4 2023.
Drs. Kimberly, Rabinstein and Chou join existing Scientific
Advisory Board members, including Dr. Andrew Ducruet, MD, an endovascular neurosurgeon
at Barrow Neurological Institute in Phoenix; Dr. Alex
Choi, MD, Associate Professor of Neurology and Neurosurgery
at UTHealth Houston/ McGovern Medical School as well as Director of
Neurocritical Care at Memorial Hermann Hospital; and Dr. R. Loch
Macdonald, MD, PhD, Acasti's
recently appointed Chief Medical Officer, a respected
physician-scientist in aSAH, as well as the former founder of a
clinical-stage biotechnology company focused on aSAH.
"Acasti's Scientific Advisory Board now has a perfect blend of
clinical expertise including neurosurgery and neurocritical care
from the leading academic medical centers in the country," Kohli
concluded.
About W. Taylor Kimberly,
M.D., PhD
W. Taylor Kimberly, MD PhD is
Chief of the Division of Neurocritical Care, and a stroke and
critical care neurologist in the Department of Neurology at
Massachusetts General Hospital.
Clinically, he primarily cares for patients in the Neuroscience
ICU as part of an integrated and multi-disciplinary team,
coordinating care with Neurosurgery and Neuroendovascular
specialists. He sees Neuro ICU patients in follow-up in outpatient
clinic as part of the NeuroRecovery clinical team. He serves on
several hospital-based and national committees that focus on
clinical guideline development and care improvement.
Dr. Kimberly's research group is located in the Center for
Genomic Medicine (Kimberly Lab), and
studies metabolomic and neuroimaging biomarkers of subarachnoid
hemorrhage, stroke and cerebral edema. The goal of his research is
to identify novel pathways and candidate therapeutic targets for
the treatment of acute brain injury. Dr. Kimberly has co-led
multi-site, randomized, placebo-controlled trials in the prevention
of brain edema, and currently co-leads an international phase 3
trial evaluating the safety and efficacy of intravenous
glibenclamide for the prevention of brain edema after large
hemispheric stroke.
About Alejandro A. Rabinstein, M.D.
Dr. Alejandro A. Rabinstein is Professor of Neurology at Mayo
Clinic and a diplomate of the American Board of Psychiatry and
Neurology (ABPN). Hs is also boarded in Vascular Neurology and
Neurocritical Care. He currently serves as Chair of the Division of
Neurocritical Care and Hospital Neurology at Mayo Clinic,
Rochester. He is a fellow of the
American Academy of Neurology (FAAN), the American Neurological
Association (FANA), the American Heart Association (FAHA) and the
Neurocritical Care Society (FNCS). He has authored over 700 papers,
12 books and multiple chapters on various topics related to
Neurocritical Care and Stroke. He is currently Associate Editor of
the journals JAMA Open and Neurocritical Care, Assistant Editor of
Stroke, and section editor for UpToDate.
About Sherry H-Y. Chou MD. MSc.
Dr. Sherry H-Y Chou, MD MSc. is Chief of Neurocritical Care
Division in the Department of Neurology and Associate Professor of
Neurology (Neurocritical Care) at the Northwestern University Feinberg School of
Medicine, and Medical Director of the Neuro/Spine ICU at
Northwestern Memorial Hospital. Dr. Chou is a fellow of the
Neurocritical Care Society (FNCS) and a fellow of critical care
medicine (FCCM), and serves on the board of directors for the
Neurocritical Care Society (NCS).
Dr. Chou is a physician-scientist with expertise in clinical
neurology, neurocritical care and vascular neurology. Dr. Chou's
research program focuses on the role of inflammation and immune
response in vascular brain injuries and biomarker discovery,
particularly in subarachnoid hemorrhage. Dr. Chou is an expert in
clinical biomarker discovery and multicenter clinical trials in
critically ill patient with SAH. Dr. Chou has led the
biomarker section in large international collaboratives such as the
National Institute of Neurological Disorders SAH common data
element (CDE) in biospecimens and biomarkers.
About aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH is bleeding over the surface of the brain in the
subarachnoid space between the brain and the skull, which contains
blood vessels that supply the brain. A primary cause of such
bleeding is rupture of an aneurysm. Approximately 70% of aSAH
patients experience death or dependence, and a third die within one
month after the hemorrhage (Becske, 2018). Approximately 50,000
patients are affected by aSAH per year, based on market research
conducted by Fletcher Spaght.
About GTX-104
GTX-104 is a clinical stage, novel aqueous formulation of
nimodipine being developed for IV infusion in aSAH patients to
address significant unmet medical needs. GTX-104 provides a more
convenient IV delivery of nimodipine in the ICU eliminating the
need for nasogastric tube administration of the drug in unconscious
or dysphagic patients. Due to IV delivery, GTX-104 also has the
potential to lower food effects, drug-to-drug interactions, and
eliminate potential dosing errors. Further, GTX-104 has the
potential to better manage hypotension in aSAH patients. GTX-104
has been dosed in over 150 healthy subjects and was well tolerated
with significantly lower inter and intra subject PK variability
compared to the oral drug. The addressable market in the United States for GTX-104 is estimated to
be about $300 million, based on
market research conducted by Fletcher
Spaght.
About Acasti
Acasti is a late-stage biopharma company with drug candidates
addressing rare and orphan diseases. Acasti's novel drug delivery
technologies have the potential to improve the performance of
currently marketed drugs by achieving faster onset of action,
enhanced efficacy, reduced side effects, and more convenient drug
delivery. Acasti's lead clinical assets have each been granted
Orphan Drug Designation by the FDA, which provides seven years of
marketing exclusivity post-launch in the
United States, and additional intellectual property
protection with over 40 granted and pending patents. Acasti's lead
clinical asset, GTX-104, is an intravenous infusion targeting
aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and
life-threatening medical emergency in which bleeding occurs over
the surface of the brain in the subarachnoid space between the
brain and skull. For more information, please visit:
https://www.acasti.com.
Forward-Looking Statements
Statements in this press release that are not statements of
historical or current fact constitute "forward-looking statements"
within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995, as amended, Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, and "forward-looking information" within the meaning of
Canadian securities laws (collectively, "forward-looking
statements"). Such forward looking statements involve known and
unknown risks, uncertainties, and other factors that could cause
the actual results of Acasti to be materially different from
historical results or from any future results expressed or implied
by such forward-looking statements. In addition to statements which
explicitly describe such risks and uncertainties, readers are urged
to consider statements containing the terms "believes," "belief,"
"expects," "intends," "anticipates," "estimates", "potential,"
"should," "may," "will," "plans," "continue", "targeted" or other
similar expressions to be uncertain and forward-looking. Readers
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
The forward-looking statements in this press release, including on
the Company's anticipated cash runway, are based upon Acasti's
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of various risks and
uncertainties, including, without limitation: (i) the success and
timing of regulatory submissions of the planned Phase 3 safety
study for GTX-104; (ii) regulatory requirements or developments and
the outcome and timing of the proposed IND application for GTX-104;
(iii) changes to clinical trial designs and regulatory pathways;
(iv) legislative, regulatory, political and economic developments;
and (v) actual costs associated with Acasti's clinical trials as
compared to management's current expectations. The foregoing list
of important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors detailed in documents that
have been and are filed by Acasti from time to time with the
Securities and Exchange Commission and Canadian securities
regulators. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Acasti
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made, except as required by applicable securities
laws. The NASDAQ does not accept responsibility for the adequacy or
accuracy of this release.
Acasti Contact:
Prashant
Kohli
Chief Executive Officer
Tel: 450-686-4555
Email:info@acasti.com
www.acasti.com
Investor Relations:
Robert
Blum
Lytham Partners, LLC
602-889-9700
ACST@lythampartners.com
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SOURCE Acasti Pharma Inc.