Acasti Pharma Provides Clinical and Market Update
September 18 2018 - 8:52AM
TRILOGY phase 3 studies exceed 75% enrollment; on
track to report topline results in 2019
Acasti Pharma Inc. (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 provided a clinical and market update.
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “I am pleased to report we remain on track with
our two TRILOGY Phase 3 studies, and expect to complete enrollment
this year. As of today, we have exceeded 75% enrollment and
30% randomization at clinical sites across the U.S., Canada, and
Mexico. We look forward to completing the studies on schedule
and reporting topline results before the end of 2019.”
“We remain very encouraged by the outlook for
CaPre. Prior to commencing our Phase 3 trials, CaPre was studied in
four clinical trials totaling 773 patients, a substantial patient
population. Based on the data in our earlier trials, CaPre showed a
significant reduction of triglycerides (TG) and non-high density
lipoprotein cholesterol (non-HDL-C) levels in the blood of patients
with mild to severe HTG, and had no safety concerns. Unlike
competitive prescription OM3 products, CaPre also showed the
potential to reduce LDL-C (“bad cholesterol”) and increase
high-density lipoprotein cholesterol (HDL-C), or “good”
cholesterol, at the therapeutic dose of 4 grams/day. Patients with
diabetes in our Phase 2 trials also showed a significant reduction
of HbA1c, indicating that CaPre may improve glucose metabolism.
These unique clinical benefits are a result of CaPre’s proprietary
omega-3 (OM3) phospholipid formulation, which combines EPA and DHA,
and delivers both of these OM3s important for heart health either
bound to phospholipids or as free fatty acids – both forms are
readily absorbed by the body. Consequently, patients taking CaPre
can remain on their physician prescribed low fat diet and get full
efficacy benefit. We believe these and other advantages set CaPre
apart as potentially best-in-class.”
“The U.S. is the largest market for prescription
OM3s with approximately 3 to 4 million patients diagnosed with
severe hypertriglyceridemia and about 5 million scripts written
each year. Two FDA approved prescription OM3s (VASCEPA and EPANOVA)
are currently being tested in extensive cardiovascular outcome
trials (REDUCE-IT and STRENGTH respectively). If these studies
successfully prove that reducing triglycerides in HTG patients
taking a prescription OM3 on top of a statin reduces residual
cardiovascular risk, there is potential to expand the addressable
market ten-fold to the roughly 36 million patients with high
triglycerides (blood levels between 200 – 499 mg/dL) (The American
Heart Association Scientific Statement on Triglycerides and
Cardiovascular Disease, 2011). While we are encouraged by the
market expansion potential from these trials, it is also important
to note that CaPre is highly differentiated for many of the
aforementioned reasons, and could overcome the shortcomings of
existing prescription OM3s due to its unique composition,
formulation and resulting clinical benefits. Given these
advantages, we believe the potential of CaPre will remain
significant, regardless of the outcome of these trials. As a
result, Acasti may elect to conduct at least one post-approval
clinical trial to support FDA approval of a supplemental New Drug
Application to expand CaPre’s indications to this
segment.”
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 that 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.
Acasti’s CaPre 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. 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 support FDA approval of a supplemental New Drug
Application 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; the timing and
the outcome of licensing negotiations; CaPre’s potential to become
the “best-in-class” cardiovascular drug for treating severe
Hypertriglyceridemia (HTG), Acasti’s ability to commercially launch
CaPre, and, Acasti’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’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.comwww.acastipharma.com
U.S. Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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