STRIVE-ON is a pivotal Phase 3 trial of
GTX-104 to evaluate its comparable safety and tolerability profile
relative to oral nimodipine in patients hospitalized with
aSAH
LAVAL, QB, July 10,
2023 /PRNewswire/ -- Acasti Pharma Inc. (Nasdaq:
ACST) ("Acasti" or the "Company"), a late-stage, biopharma company
advancing GTX-104, today announced WuXi Clinical Development, Inc.
("WuXi Clinical"), a wholly owned subsidiary of WuXi AppTec, a
global Contract Research Organization (CRO), will conduct Acasti's
STRIVE-ON Phase 3 safety trial for GTX-104. GTX-104 is Acasti's
novel, injectable nimodipine formulation for intravenous infusion
(IV) that addresses high, unmet medical needs for a rare disease,
aneurysmal subarachnoid hemorrhage (aSAH). STRIVE-ON (Safety,
Tolerability, Randomized, IV and Oral Nimodipine) will
evaluate GTX-104's comparable safety and tolerability profile
relative to oral nimodipine in patients hospitalized with aSAH.
"WuXi Clinical is a leader in the CRO industry with a strong
track record in successfully helping pharmaceutical companies
develop innovative therapies," said Prashant Kohli, CEO of Acasti. "Importantly,
they are one of the few CROs with significant experience in aSAH
and rare diseases, making them the ideal partner for conducting the
STRIVE-ON Phase 3 safety trial for GTX-104."
Over the past few months, Acasti and WuXi Clinical have been
conducting preparatory work in advance of Acasti's recent alignment
with the U.S. Food and Drug Administration (FDA) on the protocol
for its pivotal Phase 3 trial of GTX-104. In addition, the FDA also
provided Acasti guidance for a potential GTX-104 New Drug
Application (NDA) package. Acasti is anticipating dosing the first
patient in the fourth calendar quarter of 2023 and a potential NDA
submission in the first half of calendar 2025.
"We are honored and pleased that Acasti has selected WuXi
Clinical as its CRO partner to continue the clinical development of
GTX-104. We appreciate the partnership, and our dedicated team is
looking forward to assisting the Acasti team to advance GTX-104,"
says Steven Nelson, Vice President
of Global Clinical Operations at WuXi Clinical.
About the STRIVE-ON Phase 3 Safety Trial
STRIVE-ON will be a prospective, open-label, randomized (1:1
ratio), parallel group trial of GTX-104 compared with oral
nimodipine, in patients hospitalized for aSAH. Key trial design
features include:
- Approximately 100 patients are expected to be enrolled at an
estimated 25 hospitals in the U.S.
- The primary endpoint is safety and will be measured as
comparative adverse events, including hypotension, between the two
groups.
- GTX-104 will be administered as a continuous IV infusion of
0.15 mg/hour, and a 30-minute IV bolus of 4 mg every 4 hours. Oral
nimodipine will be administered as 60 mg (two 30 mg capsules) every
4 hours.
- Both groups will receive their assigned GTX-104 or oral
nimodipine for up to 21 consecutive days and will be evaluated from
commencement of patient treatment through a 90-day follow-up
period.
About WuXi Clinical Development
WuXi Clinical Development Inc., a wholly owned subsidiary of
WuXi AppTec, is a global Contract Research Organization (CRO)
providing a comprehensive range of services in clinical
development. WuXi Clinical Development Inc. provides Phase I to
Phase IV research & Bioequivalence studies for pharmaceuticals,
biologics, and medical devices. With expertise spanning across all
major therapeutic areas, WuXi Clinical Development Inc. delivers
the unique blend of an experienced team combined with data-driven
insights and responsiveness for better outcomes. WuXi Clinical
Development Inc.'s forward-thinking approach has allowed it to
accelerate a variety of clinical projects ranging from
first-in-human products to marketed drugs and devices.
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 the rupture of an aneurysm. Approximately 70% of aSAH
patients experience death or dependence, and more than 30% die
within one month of hemorrhage. Approximately 50,000 patients in
the United States are affected by
aSAH per year, based on market research.
About GTX-104
GTX-104 is a clinical stage, novel, injectable formulation of
nimodipine being developed for intravenous infusion (IV) in aSAH
patients to address significant unmet medical needs. The unique
nanoparticle technology of GTX-104 facilitates aqueous formulation
of insoluble nimodipine for a standard peripheral IV infusion.
GTX-104 provides a convenient IV delivery of nimodipine in the
Intensive Care Unit potentially eliminating the need for
nasogastric tube administration in unconscious or dysphagic
patients. Intravenous delivery of 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
administered in over 150 healthy volunteers and was well tolerated
with significantly lower inter- and intra-subject pharmacokinetic
variability compared to oral nimodipine. The addressable market in
the United States for GTX-104 is
estimated to be about $300 million,
based on market research.
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.acastipharma.com/en.
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
statements regarding the timing of the planned initiation of the
Company's STRIVE-ON trial, anticipated NDA submission with the FDA,
GTX-104's potential to bring enhanced treatment options to patients
suffering from aSAH, and the anticipated trial design of STRIVE-ON
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. NASDAQ does not accept responsibility for the adequacy or
accuracy of this release.
For more information, please contact:
Acasti Contact:
Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email:info@acastipharma.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.
