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 reported additional milestones
reached and provided a business update on its clinical trials.
Pierre Lemieux, Ph.D., COO and CSO of Acasti,
commented, “Our TRILOGY Phase 3 trials in patients with severe
hypertriglyceridemia (triglyceride blood levels from 500 mg/dL to
1500 mg/dL) continue to progress, and we remain on track to report
topline TRILOGY 1 results in December 2019, and topline TRILOGY 2
results in January 2020. Importantly, both of our TRILOGY studies
have achieved 100% patient randomization, and nearly 80% of the
patients in both studies combined have now completed their 6-month
plan. It is important to note that data clean up is approximately
90% complete in TRILOGY 1, bringing us closer to database
lock. We have also progressed TRILOGY 2 and anticipate
database lock as planned in January 2020.”
Jan D’Alvise, president and CEO of Acasti,
further noted, “Given the positive results we saw from our Phase 2
trials in a total of 675 patients, we eagerly await the completion
of the results from our two TRILOGY clinical studies. It is also
important to note:
- patients enrolled in the Phase 3 TRILOGY trials have higher
baseline triglyceride levels (above 500 mg/dl) versus our Phase 2
studies, where most had baseline triglycerides significantly below
500 mg/dl;
- patients randomized to CaPre in the Phase 3 TRILOGY trials all
received 4 grams per day and will remain on drug for 6 months,
while our Phase 2 studies included patients receiving a range of
doses from 1 gram, 2 grams and 4 grams per day for only 8 to 12
weeks with a favorable dose response;
- the Phase 2 trials also indicated that CaPre may have a
positive effect on other major lipid markers such as VLDL, LDL-C,
and HDL-C, as well as HbA1c in patients with diabetes.”
As previously disclosed, topline results will
include a readout of the primary endpoint, which is intended to
show CaPre’s overall impact on lowering triglycerides (TGs) after
12 weeks compared to placebo. The placebo used in the TRILOGY
trials is cornstarch, which is inert, and consequently is expected
to have a neutral effect on key biomarkers of patients in the
placebo group. The TRILOGY studies are designed to provide at least
90% statistical power to detect a difference of at least a 20%
decrease from baseline in TGs between CaPre and placebo.
The Company has shared the statistical analysis
plan (SAP) for the analysis and reporting of the TRILOGY results
with the FDA, and expects to finalize the SAP prior to final
database lock. Subject to any input from the FDA, Acasti is
currently planning that the topline TRILOGY results will include
the primary endpoint of TG reduction at Week 12 compared to
placebo. Safety and tolerability (e.g. overall adverse events (AE)
and serious AE rate, any discontinuation due to AEs, and AEs of
special interest such as gastrointestinal events) will also be
reported.
The Company currently expects that topline
results will not include any secondary or exploratory endpoints.
The important secondary and exploratory endpoint results are
expected to follow shortly after the release of the topline results
of TRILOGY 2, currently anticipated in late January, 2020.
According to the SAP, the primary endpoint must first be positive
with statistical significance prior to analyzing the secondary and
exploratory endpoints. These endpoints will then be analyzed in the
following order: 1) additional TG secondary endpoints, including TG
reduction at Week 26, which is intended to show CaPre’s persistence
of effect, TG reduction in various subgroups to show consistency of
effect (such as patients stratified with baseline qualifying TG
levels of ≤750 mg/dL vs. >750 mg/dL), and a comparison of TG
reduction in patients using and not using statins at baseline; 2)
Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c. Physician
investigators determined if patients with high LDL-C and/or high
HbA1c levels at screening needed to be put on standard therapy, and
if so, they were stabilized prior to being randomized into TRILOGY.
Results for both LDL-C and HbA1c will then require subgroup
analyses, which are done by combining diabetic patients and
separately patients with high LDL-C from both studies at baseline
to reach adequate statistical power to detect a difference if one
exists, and therefore potentially show any incremental benefit of
CaPre above and beyond the standard of care. Acasti expects that
the remaining secondary and exploratory endpoints along with
various additional subgroup analyses should be completed before the
end of March 2020.
In addition to the preliminary topline data, the
Company will seek to present the full data set, which will include
results for key secondary and exploratory endpoints of interest
such as Non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at key scientific
meetings in 2020. The Company will communicate more
information in the months ahead on how and when all of the TRILOGY
results will be reported once the SAP is finalized.
Jan D’Alvise concluded, “We are well capitalized
beyond completion of our Phase 3 trials with over $25 million of
cash as of June 30th, plus $8.1 million in additional proceeds from
5.9 million warrants exercised during the period from July 1 to
August 12, 2019, which includes funding to progress preparation of
the NDA, assuming the TRILOGY Phase 3 program is successful,
as well as expanded business and US commercial launch
activities. Assuming our TRILOGY trials replicate our Phase 2 data,
we believe CaPre has the potential to provide an attractive
alternative to current therapies, and thus improve the lives of the
millions of patients with cardiometabolic disease.”
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 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 third-party outcomes studies.
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”, “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’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, CaPre’s potential to meet or exceed the target
primary endpoint of reducing triglycerides by 20% compared to
placebo, 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
Investor
Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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