Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST –
TSX-V: ACST), a biopharmaceutical innovator focused on the
research, development and commercialization of its
prescription drug candidate CaPre® (omega-3 phospholipid) for the
treatment of severe hypertriglyceridemia, today announced that it
has filed its meeting request with the Food and Drug Administration
(FDA). The meeting is intended to discuss TRILOGY 1 data, and gain
alignment with the FDA on the interpretation of the results.
The Company will also seek the FDA’s input on Acasti’s proposed
revisions to the pre-specified TRILOGY 2 statistical analysis plan
(SAP), and explore and agree on a plan for pooling the data from
TRILOGY 1 and TRILOGY 2 in support of an NDA filing. Acasti
remains blinded to the TRILOGY2 results, and intends to update the
statistical analysis plan (SAP) with these revisions if the FDA
agrees. As previously noted, upon submission of the meeting
request, Acasti anticipates meeting with the FDA in the second half
of June.
Jan D’Alvise, President and CEO of Acasti
Pharma, commented, “We are pleased to have completed the TRILOGY 1
clinical site and central lab audits as planned, including
additional post-hoc analyses, and to have submitted our meeting
request to the FDA on schedule. We believe the FDA meeting will
provide essential guidance as we prepare to unblind and conduct the
topline analysis of the TRILOGY 2 data. We look forward to meeting
with the FDA and providing further updates as they unfold.”
Annual Stock Option Grants
Acasti also announced today the annual grant of
stock options to its employees, executives and directors, and the
amendment of its stock option plan (the “Stock Option Plan”). The
stock options were granted by the Board of Directors as part of the
Company’s annual performance review in accordance with the
Company’s Long-Term Incentive Program (LTIP). On March 31, 2020, an
aggregate of 3,836,000 stock options were granted to certain
employees, executives and directors of the Company under the
Company’s Stock Option Plan. Subject to the terms and conditions of
the Stock Option Plan, options granted to directors will vest in
equal monthly installments over a period of 12 months and options
granted to executives and employees will vest in equal quarterly
installments over a period of 36 months. Each option will entitle
the holder to purchase one common share of Acasti at a price of
CDN$0.53, until March 31, 2030.
Subject to the approvals of the TSX Venture
Exchange and of shareholders at the Company’s next annual and
special meeting, on March 31, 2020, the Board of Directors amended
the Stock Option Plan in order to reduce the minimum vesting period
applicable for grants to directors from 18 months on a quarterly
basis to 12 months on a monthly basis.
About CaPre (omega-3
phospholipid)
Acasti’s prescription drug candidate, CaPre, is a highly
purified omega-3 phospholipid concentrate derived from krill oil,
and is being developed to treat severe hypertriglyceridemia, a
metabolic condition that contributes to increased risk of
cardiovascular disease and pancreatitis. Its omega-3s, principally
EPA and DHA, are either “free” or bound to phospholipids, which
allows for better absorption into the body. Acasti believes that
EPA and DHA are more efficiently
transported by phospholipids sourced from krill oil than the EPA
and DHA contained in fish oil that are transported either by
triglycerides (as in dietary supplements) or as ethyl esters in
other prescription omega-3 drugs, which must then undergo
additional digestion before they are ready for transport in the
bloodstream. Clinically, the phospholipids may not only improve the
absorption, distribution, and metabolism of omega-3s, but they may
also decrease the synthesis of LDL cholesterol in the liver, impede
or block cholesterol absorption, and stimulate lipid secretion from
bile. In two Phase 2 studies, CaPre achieved a statistically
significant reduction of triglycerides and non-HDL cholesterol
levels in patients across the dyslipidemia spectrum from patients
with mild to moderate hypertriglyceridemia (patients with TG blood
levels between 200mg/dl and 500mg/dl) to patients with severe
hypertriglyceridemia (those with TG levels above 500mg/dl).
Furthermore, in the Phase 2 studies, CaPre demonstrated the
potential to actually reduce LDL, or “bad cholesterol”, as well as
the potential to increase HDL, or “good cholesterol”, especially at
the therapeutic dose of 4 grams/day. The Phase 2 data also showed a
significant reduction of HbA1c at a 4 gram dose, suggesting that
due to its unique omega-3/phospholipid composition, CaPre may
actually improve long-term glucose metabolism. Acasti’s TRILOGY
Phase 3 program is currently underway.
About Acasti Pharma
Acasti is a biopharmaceutical innovator advancing a potentially
best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid),
for the treatment of hypertriglyceridemia, a chronic condition
affecting an estimated one third of the U.S. population. Since its
founding in 2008, Acasti has focused on addressing a critical
market need for an effective, safe and well-absorbing omega-3
therapeutic that can make a positive impact on the major blood
lipids associated with cardiovascular disease risk. The Company is
developing CaPre in a Phase 3 clinical program in patients with
severe hypertriglyceridemia, a market that includes 3 to 4 million
patients in the U.S. The addressable market may expand
significantly if omega-3s demonstrate long-term cardiovascular
benefits in on-going outcomes studies (REDUCE-IT and STRENGTH).
Acasti may need to conduct at least one additional clinical trial
to expand CaPre’s indications to this segment. Acasti’s strategy is
to commercialize CaPre in the U.S. and the Company is pursuing
development and distribution partnerships to market CaPre in major
countries around the world. For more information, visit
www.acastipharma.com.
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 U.S. federal
securities laws (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 labeled with the terms “believes,” “belief,”
“expects,” “intends,” “anticipates,” “potential,”
“should,” “may,” “will,” “plans,” “continue” 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.
Forward-looking statements in this press release include, but are
not limited to, information or statements about Acasti’s strategy,
future operations, prospects and the plans of management; Acasti’s
ability to conduct all required clinical and non-clinical trials
for CaPre, including the timing and results of those trials;
CaPre’s potential to become the “best-in-class” cardiovascular drug
for treating severe Hypertriglyceridemia (HTG); and the timing and
outcome of our requested meeting with the FDA.
The forward-looking statements contained in this
press release are expressly qualified in their entirety by this
cautionary statement, the “Cautionary Note Regarding
Forward-Looking Information” section contained in Acasti’s latest
annual report on Form 20-F and most recent management’s discussion
and analysis (MD&A), which are available on SEDAR at
www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, and on
the investor section of Acasti’s website at www.acastipharma.com.
All forward-looking statements in this press release are made as of
the date of this press release. Acasti does not undertake to update
any such forward-looking statements whether as a result of new
information, future events or otherwise, except as required by law.
The forward-looking statements contained herein are also subject
generally to assumptions and risks and uncertainties that are
described from time to time in Acasti’s public securities
filings with the Securities and Exchange Commission and
the Canadian securities commissions, including Acasti’s
latest annual report on Form 20-F and most recent MD&A.
Neither NASDAQ, the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Acasti Contact:Jan
D’AlviseChief Executive OfficerTel: 450-686-4555Email:
info@acastipharma.com www.acastipharma.com
Investor
Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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