Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and
TSX-V: ACST), today announced positive results for GTX-104 based on
its interim analysis of the first 20 of 50 normal healthy subjects
in its pivotal pharmacokinetic (PK) bridging study. GTX-104 met
both primary endpoints for Maximum Concentration (Cmax) on Day 1
and Area Under the Concentration-Time Curve (AUC 0-24 hours) on Day
3, allowing the study to continue under the current infusion
protocol to its completion. GTX-104 is a novel, aqueous formulation
of nimodipine developed as an IV infusion for patients experiencing
Subarachnoid Hemorrhage, or bleeding over the surface of the brain
triggered by a ruptured aneurysm (aSAH).
The Company believes that the tight correlation
of the primary endpoint data for the first 20 patients is a strong
indication that GTX-104 could achieve comparable bioavailability
with oral nimodipine in the full study cohort of 50 subjects. As
observed in a previous PK study, the inter- and intra-subject
variability in the interim analysis was much lower for GTX-104 as
compared with oral nimodipine. So far, there have been no serious
adverse events observed, and only mild adverse events were reported
in both groups such as headaches, that were resolved with common
medications.
"This interim data is very encouraging, as it
suggests that our current infusion protocol is on track to meet the
objectives for this pivotal PK study. As previously disclosed, we
expect to report the final study results sometime in the first half
of 2022. If the final study results are consistent with these
interim results, we could proceed quickly to finalize the study
design and protocol for the Phase 3 Safety Study of GTX-104 with
the FDA, and initiate the study in the second half of 2022,”
commented Jan D’Alvise, Acasti’s CEO. “Importantly, we believe the
follow-up safety study has the potential to be relatively fast, low
cost and low risk based on the favorable safety profile observed to
date. Moreover, this clinical study is expected to be the final
step required to seek regulatory approval under the 505(b)(2)
regulatory pathway before submitting our New Drug Application (NDA)
to the FDA.
“We believe GTX-104 delivered intravenously has
the potential to be a more convenient, efficient and controlled way
to deliver nimodipine. Importantly, because of its better
absorption profile and more consistent blood levels, GTX-104 may
provide physicians with a more reliable and effective tool for
hypotension management. This is a key advantage, as GTX-104 could
help to reduce the incidence of vasospasm, which requires immediate
and costly intervention and can lead to worse outcomes for the
patient. For these reasons, we believe GTX-104 could be well
positioned to rapidly capture market share if we are granted FDA
approval.
“This interim data is further validation of our
strategic decision to acquire Grace Therapeutics. In just three
months since completing the acquisition, we launched this pivotal
PK bridging study for GTX-104 and already have positive interim
data with more data to follow in the first half of 2022. We are
also working diligently to rapidly advance the clinical programs
for GTX-102 and GTX-101. As a result, we remain encouraged by the
outlook for our business and look forward to reporting on a number
of key upcoming milestones that we believe could drive significant
value for our shareholders,” concluded Ms. D’Alvise.
The PK bridging study for GTX-104 is being
conducted in a total of 50 healthy subjects as a single center,
randomized, two-period crossover study. The overall objective of
the study is to evaluate and compare the relative bioavailability
of GTX-104, with the currently marketed oral nimodipine capsules,
which are the standard of care, while a secondary objective of the
study is to assess the safety and tolerability of GTX-104, as
compared to oral nimodipine capsules. Throughout the study, safety
evaluations are being conducted, which include capturing any
treatment-emergent adverse events, serious adverse events,
electrocardiogram data, clinical laboratory evaluations, physical
examinations and resting vital signs, including blood pressure.
Subjects are admitted to the clinical research unit on the day
prior to dosing, and they remain domiciled in the clinical research
unit (CRU) for the duration of each study period.
Per the study protocol, subjects are being
randomly assigned in a 1:1 ratio to one of two treatment sequences,
with a cross over design: Group A switching to Group B, where
GTX-104 is administered first, or Group B switching to Group A,
where oral nimodipine capsules are administered first. In both
groups, GTX-104 nimodipine is administered intravenously over a
72-hour period, and nimodipine is administered orally with water
every 4 hours for 72 hours.
About SAH
Subarachnoid Hemorrhage (SAH) 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. The result is a relatively uncommon type of stroke that
accounts for about 5% of all strokes and has an incidence of six
per 100,000 person years (Becske, 2018).
In contrast to 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, around 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 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).
Nimodipine, a calcium channel blocker, is
currently the only FDA approved therapy to improve neurological
outcomes associated with DCI in SAH patients. Its use is
recommended in the current guidelines for the management of SAH, as
published by the American Heart Association and American Stroke
Association.
About GTX-104
GTX-104 is a clinical stage, novel aqueous
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. Acasti estimates the addressable
market in the United States for GTX-104 to be approximately $300
million based on approximately 50,000 patients being affected by
aSAH per year.
About Acasti
Acasti is a specialty pharma company with drug
delivery capability and technologies 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 protection by over 40 granted and pending
patents. The lead 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 impacts children
causing severe disability, 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 labelled with the terms “believes,” “belief,” “expects,”
“intends,” “anticipates,” “potential,” “should,” “may,” “will,”
“plans,” “continue”, “targeted”, “estimates” 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.
These forward-looking statements 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 and 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, (v)
the final outcome of Acasti’s PK bridging study for GTX-104; and
(vi) the effects of COVID-19 on clinical programs and business
operations. The foregoing review 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 SEC. 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 under 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.com www.acastipharma.com
Investor Contact:Crescendo
Communications, LLC Tel: 212-671-1020Email:
ACST@crescendo-ir.com
Media Contact :Jules Abraham
JQA Partners, Inc.Tel: 917-885-7378Email:
jabraham@jqapartners.com
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