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’s TRILOGY 2 trial studying CaPre in patients with severe
hypertriglyceridemia has achieved 100% patient randomization.
This follows the Company’s prior announcement in April 2019 that
the Company’s TRILOGY 1 trial had achieved 100% patient
randomization.
The Company also announced that its two on-going
Phase 3 TRILOGY trials (TRILOGY 1 and TRILOGY 2) have exceeded the
target of a combined 500 randomized patients, and more than 60% of
the patients in both trials have already completed their 6-month
treatment plan.
The fact that both studies have now reached full
randomization means that the “last patient, last visit” in the
TRILOGY 1 trial is on track to take place in November, and the
“last patient, last visit” in the TRILOGY 2 trial is on track to
take place in December. It is then anticipated to take
approximately 1 month for data clean-up prior to moving to database
lock. Once the database is locked, the Company expects
topline results for TRILOGY 1 to be released in December 2019 and
TRILOGY 2 to be released in January 2020. Topline results will
include readout of the primary endpoint, which will show CaPre’s
overall impact on lowering triglycerides after 12 weeks. In
addition, the topline results will include CaPre’s impact on
several important secondary endpoints such as LDL, VLDL and HDL
cholesterol and non-HDL cholesterol, as well as HbA1c, an
exploratory endpoint which is an important biomarker of glucose
control for diabetic patients. The full data set will include
results on a number of additional lipid, metabolic and inflammatory
markers including CRP, APOA1, APOB, APOA5, APOC3, Lp-PLA2, PCSK9,
RLP-C and others. The Company plans to submit the full data set as
a late breaker presentation at the American College of Cardiology
at the end of March 2020.
Pierre Lemieux, Ph.D., COO and CSO of Acasti,
commented, “Both of our TRILOGY Phase 3 trials remain on track and
are proceeding according to plan. Consistent with our prior
disclosures, there have been no severe adverse events associated
with our product to date, and we continue to experience a lower
than expected drop-out rate, supporting the high safety profile and
patient acceptability of CaPre. Importantly, we are encouraged by
the growing excitement within the industry as we eagerly await the
results of our TRILOGY program. We appreciate the on-going
support of all of the investigators involved with these trials at
more than 150 clinical sites across the U.S., Canada, and Mexico.”
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 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 Pharma 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 Pharma 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. Acasti Pharma 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 third-party outcomes studies.
Acasti Pharma may need to conduct at least one additional clinical
trial to support FDA approval of a supplemental New Drug
Application to expand CaPre’s indications to this segment. Acasti
Pharma’s strategy is to commercialize CaPre in the U.S. and Acasti
Pharma 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 Pharma 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”, “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.
Forward-looking statements in this press release include, but are
not limited to, information or statements about Acasti Pharma’s
strategy, future operations, prospects and the plans of management;
Acasti Pharma’s ability to conduct all required clinical and
non-clinical trials for CaPre, including the timing and results of
those trials; the timing and the outcome of licensing negotiations;
CaPre’s potential to become the “best-in-class” cardiovascular drug
for treating severe hypertriglyceridemia, Acasti Pharma’s ability
to commercially launch CaPre, and, Acasti Pharma’s ability to fund
its continued operations.
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 Pharma’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 Pharma’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
Pharma 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 Pharma’s public securities filings with the
Securities and Exchange Commission and the Canadian securities
commissions, including Acasti Pharma’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,
President and Chief Executive Officer Tel: 450-686-4555 Email:
info@acastipharma.com www.acastipharma.com
Investor Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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