Acasti Pharma Receives Funding from the Government of Canada to Expand Production Capacity
September 09 2019 - 08:30AM
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 (HTG), today announced that the
Company has been awarded up to $750,000 in non-dilutive and
non-repayable funding, as well as technical and business advisory
services, from the National Research Council of Canada Industrial
Research Assistance Program (NRC IRAP) to apply towards research
and development of the Company’s unique commercial production
platform for CaPre. With NRC IRAP support, Acasti aims to expand
and enhance its production capabilities for CaPre.
“We appreciate the strong support from NRC IRAP
since 2015 and we are honored to embark on a new research and
development project with them. As we progress toward reporting our
TRILOGY topline results, which we anticipate later this year,
ramping up our commercial production capabilities is an important
next step,” said Dr. Pierre Lemieux, PhD Acasti’s Co-Founder,
Chief Operating and Scientific Officer. “Innovation has been a
key factor in Acasti’s success, and we look forward to working
closely with NRC IRAP to further the technical limits of our
manufacturing process in anticipation of full commercialization.
Under the leadership of Simon Despins, Director of Process
Development and Production at Acasti, the work will be directed
towards increasing our production capacity by leveraging our
extensive manufacturing expertise and broad patents.”
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; and CaPre’s
potential to become the “best-in-class” cardiovascular drug for
treating severe Hypertriglyceridemia (HTG).
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’Alvise Chief Executive Officer Tel: 450-686-4555Email:
info@acastipharma.com www.acastipharma.com
U.S. Contact:
David WaldmanPresidentCrescendo Communications, LLC Tel:
212-671-1020Email: ACST@crescendo-ir.com
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