LAVAL,
QC, Feb. 28, 2023 /PRNewswire/ -- Acasti
Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST and TSX-V:
ACST), a late-stage, specialty pharma company advancing three
clinical stage drug candidates addressing rare and orphan diseases,
recognizes and celebrates Rare Disease Day (February 28), as established by the European
Organization for Rare Diseases.
"Rare diseases impact approximately 300 million patients around
the world and are often chronic, progressive and frequently
life-threatening," commented Jan D'Alvise, CEO of Acasti Pharma.
"Acasti's aim is to improve clinical outcomes by applying our
proprietary formulation and drug delivery technologies to existing
pharmaceutical compounds with a goal to achieve improvements over
the current standard of care, or to provide treatment for diseases
with no currently approved therapies. Our focus today is on
developing therapies for three rare and orphan diseases, aneurysmal
subarachnoid hemorrhage (aSAH), ataxia telangiectasia (A-T) and
postherpetic neuralgia (PHN), which all combined effect
approximately 200,000 people in the
United States. We remain committed to effectively treating
the debilitating symptoms that result from these underlying rare
diseases in these underserved patient populations."
Subarachnoid Hemorrhage (SAH)
Acasti is developing GTX-104, an IV formulation of nimodipine
designed to treat SAH. 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 rupture of an aneurysm (aSAH). The company
estimates that approximately 50,000 individuals experience aSAH
each year in the US based on third party market research. There are
an estimated 150,000 aSAH patients each year in China and approximately 55,000 patients in
Europe.
Ataxia Telangiectasia (A-T)
Acasti is developing GTX-102, an oral-mucosal betamethasone
spray for the treatment of A-T. A-T is a rare genetic progressive
autosomal recessive neurodegenerative disorder that affects
children, with the hallmark symptoms of cerebellar ataxia and other
motor dysfunction, and dilated blood vessels (telangiectasia) that
occur in the sclera of the eyes. A-T is caused by mutations in the
ataxia telangiectasia gene, which is responsible for modulating
cellular response to stress, including breaks in the double strands
of DNA. It is estimated that A-T affects approximately 4,500
patients in the United States and
currently, there are no FDA approved therapies for A-T.
Postherpetic Neuralgia (PHN)
Acasti is developing GTX-101, a topical, bio-adhesive,
film-forming bupivacaine spray for PHN. PHN is associated with
significant loss of function and reduced quality of life,
particularly in the elderly. It has a detrimental effect on all
aspects of a patient's quality of life. The nature of PHN pain
varies from mild to severe, constant, intermittent, or can be
triggered by various stimuli. Approximately half of patients with
PHN describe their pain as "horrible" or "excruciating," ranging in
duration from a few minutes to constant on a daily or almost daily
basis (Katz, 2004). The pain can disrupt sleep, mood, work, and
activities of daily living, adversely impacting the quality of life
and leading to social withdrawal and depression. It is estimated
that PHN affects approximately 120,000 patients per year in
the United States, and there are
significant unmet medical needs with the current standard of
care.
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. 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
www.acastipharma.com
Investor Contact:
Lytham Partners, LLC
Robert
Blum
Tel:
602-889-9700
Email:
acst@lythampartners.com
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SOURCE Acasti Pharma Inc.