EQNX::TICKER_START
(TSX-V:ACST),(NASDAQ:ACST), EQNX::TICKER_END 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 GTX-101 compared to
the reference listed drug bupivacaine in 48 healthy subjects. Feedback
from FDA was obtained on the study protocol, and the non-objection
letter was received on July 12 from Health Canada. The First-Subject,
First-Dose was administered on July 26. The PK study is the next step in
the proposed 505(b)(2) regulatory pathway for GTX-101. This study is
expected to be completed by the end of calendar 2022 as planned and will
provide important information on the dose and dosing frequency in
humans.
GTX-101 is a novel formulation of bupivacaine hydrochloride (HCl)
for topical administration via a bio-adhesive, film-forming polymer,
for relief of pain associated with 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.
Jan D'Alvise, Chief Executive Officer of Acasti, stated, "The
initiation of this PK study for GTX-101 is yet another accomplishment
achieved in 2022 for Acasti. We now have multiple drugs in the clinic
that are progressing towards important key milestones that leverage
Acasti's novel drug delivery technologies and 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. We anticipate the completion of the PK study
for GTX-101 later this year as we look to bring this exciting new
treatment alternative to patients who suffer from PHN."
Based on market research with more than 250 physicians, the
Company believes that a significant unmet need exists for treating these
patients with PHN. Approximately 40% of patients that are prescribed
the standard of care, which includes oral gabapentin and lidocaine
patches, experience insufficient pain relief. Market research has shown
that gabapentin does not work well for this indication, it can cause
unpleasant side effects, and was recently added to the controlled
substance list in several states due to a tendency for abuse. The
lidocaine patches are difficult to use as they fall off and can cause
skin sensitivity and irritation, especially in older individuals, and
depending on their placement, are inconvenient, uncomfortable and
unattractive. Additionally, our market research noted that it could take
up to 2 weeks for the lidocaine patch to work, and they can only be
worn for 12 hours and then must be removed for another 12 hours, so
break-through pain is common. Given these issues with the oral and patch
alternatives, many PHN patients end up being prescribed opioids, which
given the abuse potential, physicians would prefer to avoid.
The potential benefits of GTX-101 could include faster onset of
action and a longer duration of pain relief which are inherent benefits
with the active ingredient bupivacaine vs. lidocaine. GTX-101 can be
conveniently sprayed on the skin wherever the pain is located, and based
on the PK profile of bupivacaine, the Company believes that GTX-101 may
have to be applied only once or twice a day to the affected area for 24
hour pain relief, although this dosing schedule will need to be
confirmed in the Company's clinical trials. Based on this product
profile, and assuming a successful development program, the Company
believes GTX-101 has the potential to be a game-changer as a non-opioid
analgesic for PHN patients who suffer from this debilitating pain.
The PK study is a Phase 1, Randomized, Single-Dose, 4-Cohort,
Parallel study to evaluate the pharmacokinetics, dose proportionality,
safety and tolerability of GTX-101 (bupivacaine hydrochloride metered
dose spray) and subcutaneous injectable bupivacaine in healthy subjects.
The primary objective is to assess the pharmacokinetics (PK) of 3 dose
levels of GTX-101 (50, 100, and 200 mg) given as a single-dose topical
application (metered spray). The study will enroll up to 48 subjects (12
subjects per cohort) to evaluate the PK of GTX-101 compared to
subcutaneous injection of bupivacaine in healthy male and female adult
subjects. Subjects in Cohorts 1, 2, and 3 will receive GTX-101 as either
5, 10, or 20 sprays (50, 100, or 200 mg, respectively). Subjects in
Cohort 4 will receive a single 10 mg subcutaneous injection of the
active control.
In addition, a pharmacodynamic assessment measuring skin
sensitivity, will be performed to collect early information on efficacy,
and to guide important further decisions for advancing GTX-101
development, such as phase 2 dosing and dose frequency.
About PHN
Postherpetic neuralgia (PHN) is neuropathic pain caused due to
damage by the varicella zoster virus. After a primary varicella
infection (chickenpox), the varicella zoster virus can remain persistent
but clinically latent in the sensory nerve ganglia for many years
before being reactivated and becoming manifest clinically as herpes
zoster. This pain may persist for months or even years and this PHN is
the most common and debilitating complication of herpes zoster.
Postherpetic neuralgia is associated with significant loss of
function and reduced quality of life, particularly in the elderly, and
is highly resistant to treatment. Since PHN is often resistant to
pharmacologic treatments, a multimodal analgesic treatment strategy is
often used to balance the efficacy and tolerability of the medication
regimen, the side effects of which can be limiting and can themselves
compromise quality of life and patient compliance. Postherpetic
neuralgia occurs most commonly in the elderly, in whom a large number of
drugs are often prescribed, and so the use of a long-acting topical
analgesic with minimal risk of systemic toxicity, would be advantageous.
Current treatment of PHN most often consists of oral gabapentin
(first line) and prescription lidocaine patches (second line), and
refractory cases may be prescribed opioids to address persistent pain.
Gabapentin and opioid abuse have continued to proliferate, and lidocaine
patches are suboptimal for many reasons. Prescription lidocaine patches
are only approved for PHN, and the market is currently made up of both
branded and generic offerings. It is estimated that PHN affects
approximately 120,000 patients per year in the United States. According
to the third-party report commissioned by Acasti, the total addressable
market for GTX-101 could be as large as $2.5 billion, consisting of
approximately $200 million for PHN pain and $2.3 billion for non-PHN
pain.
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
lifethreatening 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 PHN.
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, "forwardlooking 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'Alvise
Chief Executive Officer
Tel: 450-686-4555
Email:info@acastipharma.com
