Company successfully submits GTX-104
Pivotal Phase 3 protocol IND amendment to the FDA with expectation
for first patient dosed in calendar Q4 2023
Strategic realignment prioritizes GTX-104
and expects to extend cash runway through a potential New Drug
Application (NDA) filing for GTX-104
LAVAL, Québec, May 8, 2023
/PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company")
(Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104,
its novel formulation of nimodipine that addresses the high unmet
medical needs for a rare disease, aneurysmal subarachnoid
hemorrhage (aSAH), today announced the successful submission to the
FDA of GTX-104's full protocol of its pivotal Phase 3 Safety Study
and implementation of a strategic realignment plan to maximize
shareholder value.
Prashant Kohli, CEO of Acasti,
commented, "We are extremely pleased to execute on this important
submission milestone as we advance GTX-104, a critically important
drug candidate to the thousands of patients that suffer from
subarachnoid hemorrhage without effective treatment options. We
expect this pivotal Phase 3 Safety Study will be the final clinical
step required to seek FDA approval under the 505(b)(2) regulatory
pathway."
The realignment follows a comprehensive strategic review of the
company by Prashant Kohli, its
recently appointed CEO, and its Board of Directors.
"As a result of the positive progress made with GTX-104, and
following a strategic review, we felt it was critical to move
swiftly and boldly to implement a plan that we believe will benefit
Acasti's shareholders by prioritizing resources to this high-value
asset," Kohli continued.
Key strategies being implemented are:
- Prioritizing resources to Acasti's biggest value driver –
GTX-104. Acasti has submitted the full pivotal Phase 3 Safety Study
protocol with all supporting documentation. Pending final feedback
and approval from the FDA, the first patient, first dose for the
pivotal Phase 3 Safety Study is expected in calendar Q4 2023.
- Strategic transformation of Acasti's operating model to an
agile biopharma reflecting its complete focus on GTX-104. In
alignment with the operating model, Acasti has brought on a highly
experienced new management team with deep subject matter knowledge
and direct, hands-on clinical trial experience in aSAH.
- Significant extension of the Company's cash runway expected to
be sufficient to fund the Company through calendar Q2 2025,
facilitating achievement of critical value inflection milestones,
including a potential New Drug Application (NDA) filing for
GTX-104.
- Evaluation of strategic alternatives to maximize value of
de-prioritized pipeline assets (GTX-102 and GTX-101) including
out-licensing or sale.
Vimal Kavuru, Acasti's Board
Chair, added, "In today's current turbulent markets, we determined
it is imperative to narrow our focus to accelerate development of
GTX-104, our lead value creation driver. We believe this strategic
realignment will allow us to achieve key inflection milestones
without the near-term need for a significant dilutive capital
raise."
In connection with the transformation of the operating model,
the Company has moved to appoint the following industry experts to
its senior management team:
- Dr. R. Loch Macdonald, MD,
PhD, as Chief Medical Officer. A world-renowned practicing
neurosurgeon-scientist and respected authority in SAH, Dr.
Macdonald is the former founder of
a clinical-stage biotechnology company focused on subarachnoid
hemorrhage.
- Carrie D'Andrea, as VP Clinical Operations. Ms. D'Andrea is a
highly experienced professional who has built and led the planning,
implementation, management, and execution of global Phase 2 and
Phase 3 trials for a drug candidate for subarachnoid
hemorrhage.
- Amresh Kumar, PhD, as VP Program
Management. Mr. Kumar is an experienced drug development, CMC, and
program management expert. Amresh is the former product
leader of GTX-104 while at Grace Therapeutics (which was acquired
by Acasti).
"A key requirement of the strategic realignment was to build a
high-performing, nimble team of professionals with specific
experience in our target disease state and product knowledge. The
new Acasti is a highly motivated and energized organization that is
flatter, agile, and strategically closer to our addressable market
opportunity in the U.S. Importantly, the new team will leverage
invaluable insights in aSAH from their prior experience with a
focus on executional excellence to drive value for patients and
Acasti's shareholders," Kohli concluded.
As a result of this strategic realignment, Acasti is over time
discontinuing its operations in Canada, and has proceeded to lay off
substantially all its workforce, allowing Acasti's new management
team to rebuild a leaner organization in the United States.
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 rupture of an aneurysm. Approximately 70% of aSAH
patients experience death or dependence, and a third die within one
month after the hemorrhage (Becske, 2018). Approximately 50,000
patients are affected by aSAH per year, based on market research
conducted by Fletcher Spaght.
About GTX-104
GTX-104 is a clinical stage, novel aqueous formulation of
nimodipine being developed for IV infusion in aSAH patients to
address significant unmet medical needs. GTX-104 provides a more
convenient IV delivery of nimodipine in the ICU eliminating the
need for nasogastric tube administration of the drug in unconscious
or dysphagic patients. Due to IV delivery, 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 dosed in over 150 healthy subjects and was well tolerated
with significantly lower inter and intra subject PK variability
compared to the oral drug. The addressable market in the United States for GTX-104 is estimated to
be about $300 million, based on
market research conducted by Fletcher
Spaght.
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.acasti.com.
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 on
the Company's anticipated cash runway, 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;
(v) actual costs associated with Acasti's clinical trials as
compared to management's current expectations; and (vi) the
projected extension of the Company's cash runway to calendar Q2
2025. 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. The NASDAQ does not accept
responsibility for the adequacy or accuracy of this release.
Acasti Contact:
Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email: info@acasti.com
www.acasti.com
Investor Relations:
Robert Blum
Lytham Partners, LLC
602-889-9700
ACST@lythampartners.com
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