Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and
TSX-V: ACST), today announces the initiation of its planned
pharmacokinetic (PK) bridging study to evaluate the relative
bioavailability of intravenous (IV) GTX-104 compared to currently
marketed oral nimodipine capsules in 50 healthy subjects. The PK
study is the next required step in the proposed 505(b)(2)
regulatory pathway for GTX-104.
Results from this study are expected in the
first half of calendar 2022, and after review with the U.S. Food
& Drug Administration (FDA), will help to determine the final
design of the Company’s planned Phase 3 safety study for GTX-104 in
Subarachnoid Hemorrhage (SAH) patients. Assuming the PK study and
related FDA review progress as planned, the Company expects to
begin the Phase 3 study during the second half of 2022. GTX-104 is
a novel IV nimodipine infusion being developed to treat SAH, which
is a central nervous system condition that causes acute bleeding on
the brain and requires immediate medical attention to prevent
long-term disability or death. GTX-104 has been granted Orphan Drug
Designation by the FDA, which could provide Acasti with seven years
of market exclusivity, tax incentives and other economic
benefits.
Jan D’Alvise, Chief Executive Officer of Acasti,
stated, “We are rapidly advancing our clinical pipeline and are
proud to have already initiated this PK bridging study of GTX-104
in the short time since completing our acquisition of Grace
Therapeutics at the end of August. This latest study follows an
earlier safety and dose-escalation crossover study conducted by
Grace, which reported encouraging results.”
“We believe GTX-104 has the potential to provide
improved bioavailability and lower intra-subject variability
compared to oral capsules, which could translate into better blood
pressure control in these critically ill patients. Moreover, it
could provide a more convenient dosing schedule that would be
easier to administer to patients who are unconscious. SAH is a
devastating condition that afflicts more than 50,000 patients per
year in the United States and is one of the most expensive acute
conditions to treat. As a result, we believe GTX-104, through our
unique formulation, has the potential to address a sizable market
opportunity with a significant unmet medical need,” D’Alvise
concluded.
The PK bridging study is a single center,
randomized, two-period crossover study in 50 healthy subjects. The
primary objective of the study is to evaluate the relative
bioavailability of GTX-104, and the secondary objective of the
study is to assess the safety and tolerability of GTX-104, compared
to nimodipine oral capsules, the current standard of care.
Per the study protocol, subjects will be
randomly assigned in a 1:1 ratio to one of two treatment sequences:
AB or BA, where Treatment A and Treatment B are as
follows:
- Treatment A: GTX-104 Nimodipine IV
will be administered by infusion over 72 hours.
- Treatment B: Nimodipine capsules
will be administered orally with 240 mL of water at a dose level of
60 mg (two 30 mg capsules) every 4 hours for 72 hours.
Safety assessments will be collected throughout
the study and will include treatment-emergent adverse events,
serious adverse events, electrocardiograms, clinical laboratory
evaluations, physical examinations and resting vital signs
(including blood pressure). Per the study protocol, healthy
subjects will be admitted to the clinical research unit (CRU) on
the day prior to dosing and will remain domiciled in the CRU for
the duration of each study period.
About SAHSAH 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.
The result is a relatively uncommon type of stroke that accounts
for about one-in-twenty (5%) of all strokes and has an incidence of
six per 100,000 person years (Becske, 2018).
In contrast to more common types of stroke in
elderly individuals, SAH often occurs at a relatively young age,
with half the affected patients being younger than 60 years
(Becske, 2018). Particularly devastating for patients younger than
45, approximately 10 to 15% of aneurysmal SAH (aSAH) patients die
before reaching the hospital (Rinkel, 2016), and those who survive
the initial hours post hemorrhage are admitted or transferred to
tertiary neurointensive care centers to manage the high risk of
complications, including rebleeding and delayed cerebral ischemia
(DCI). Systemic manifestations affecting cardiovascular, pulmonary,
and renal function are common, and often complicate the management
of DCI. Approximately 70% of aSAH patients experience death or
dependence, and half die within one month after the hemorrhage. Of
those who survive the initial month, half remain permanently
dependent on someone else to maintain daily living (Becske,
2018).
About GTX-104GTX-104 is a
clinical stage, novel nanoparticle formulation of nimodipine being
developed for IV infusion in SAH patients. It incorporates
surfactant micelles as the drug carrier to solubilize nimodipine.
This nimodipine injectable formulation is comprised of a nimodipine
base, an effective amount of a hydrophilic surfactant, and a
pharmaceutically acceptable carrier for injection. GTX-104 is an
aqueous solution substantially free of organic solvents, such that
the nimodipine is contained in a concentrated injection solution,
suspension, emulsion or complex as a micelle, a colloidal particle
or an inclusion complex, and the formulation is stable and clear.
The addressable market in the United States for GTX-104 is
estimated to be about $300 million based on market research
conducted for Grace by Fletcher Spaght.
About Acasti
Acasti is a late-stage specialty pharma company
with drug delivery technologies and 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—all which
could help to increase treatment compliance and improve patient
outcomes.
Acasti’s three lead clinical assets have each
been granted Orphan Drug Designation by the FDA, which provide the
assets with 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 assets
target underserved orphan diseases: (i) GTX-104, an intravenous
infusion targeting Subarachnoid Hemorrhage (SAH), 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; (ii) GTX-102, an oral mucosal spray targeting
Ataxia-telangiectasia (A-T), a progressive, neurodegenerative
genetic disease that primarily affects children, causing severe
disability, and for which no treatment currently exists; and (iii)
GTX-101, a topical spray, targeting Postherpetic Neuralgia (PHN), a
persistent and often debilitating neuropathic pain caused by nerve
damage from the varicella zoster virus (shingles), which may
persist for months and even years. 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 information” within the meaning of Canadian
securities laws and “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
(collectively, “forward-looking statements”). Such forward looking
statements involve known and unknown risks, uncertainties, and
other unknown 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,” “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 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 PK bridging study for GTX-104 and
Acasti’s other pre-clinical and clinical trials; (ii) regulatory
requirements or developments; (iii) changes to clinical trial
designs and regulatory pathways; (iv) legislative, regulatory,
political and economic developments, and (v) the effects of
COVID-19 on clinical programs and business operations. 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 may be filed by Acasti from time to
time with the Securities and Exchange Commission. 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.
Neither NASDAQ, the TSXV nor its Regulation
Services Provider (as that term is defined in the policies of the
TSXV) accepts responsibility for the adequacy or accuracy of this
release.
Acasti Contact:Jan D’AlviseChief Executive
Officer Tel: 450-686-4555Email:
info@acastipharma.comwww.acastipharma.com
Investor Contact:Crescendo
Communications, LLC Tel: 212-671-1020Email:
ACST@crescendo-ir.com
Media Contact :Jules AbrahamJQA Partners,
Inc.Tel: 917-885-7378Email: jabraham@jqapartners.com
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