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 (sHTG) (triglyceride blood levels from
500 mg/dL to 1500 mg/dL), today announced it has completed its
revisions to the pre-specified Statistical Analysis Plan (SAP) for
the TRILOGY 2 Phase 3 trial of CaPre, and has filed it with the
Food and Drug Administration (FDA).
As previously disclosed, the Company, along with
the academic Principal Investigator (PI) of the study, Dariush
Mozaffarian M.D., Dr.P.H., and external clinical and statistical
experts, conducted rigorous post-hoc analysis of TRILOGY 1 data.
Analysis of the TRILOGY 1 data revealed a rapid, significant and
sustained reduction in TG levels between screening (during
qualification) and the time of patient randomization (prior to
patients starting on either drug or placebo), which Acasti refers
to as “Pre-randomization Triglyceride (TG) Normalization.” This
artefactual phenomenon affected both treatment groups, but was much
greater in the placebo group, resulting in the large placebo effect
and significant underestimation of the post-randomization treatment
effect of the active drug, CaPre. The post-hoc analyses of
the primary endpoint using a revised, single point baseline value
from Week 0 (Visit 4) corrected for a significant amount of the
pre-randomization TG reduction in subjects that were most affected
by the normalization phenomenon, and a meaningful efficacy trend
for CaPre was observed.
The Company provided all of the TRILOGY 1
background information and accompanying data to the FDA in a Type C
briefing package, which was filed on April 29, 2020. As previously
disclosed, the FDA provided Acasti with a written response to its
Type C Meeting request and briefing package, and confirmed that it
will require pivotal efficacy analyses for TRILOGY 2 to be
performed on the full Intent to Treat (ITT) population, as
contemplated in the original Statistical Analysis Plan (SAP), and
they supported the conduct of post-hoc analyses in TRILOGY 1 for
exploratory purposes. Based on the FDA’s feedback and input from
key experts including Dr. Mozaffarian, Acasti finalized the
Statistical Analysis Plan (SAP) for TRILOGY 2 and has now submitted
it to the FDA. The Company remains blinded to the TRILOGY 2 data,
and remains on track to report topline TG data on or about August
31, 2020. The key secondary and exploratory endpoints from both
TRILOGY 1 and TRILOGY 2 trials, and pooled results from both
studies, are still expected within several weeks following the
unblinding of TRILOGY 2 results.
Acasti also announced it plans to host a
conference call on or about August 31, 2020 to discuss the TRILOGY
2 topline results, as well as to provide an update on the timing
for the reporting of the secondary and exploratory endpoints, and
the pooled results from both TRILOGY studies. For this reason, the
Company does not plan to host its usual quarterly conference call
to discuss the financial results for the first fiscal quarter ended
June 30, 2020, but expects to report and file its first fiscal
quarter 2021 financial results on August 13, 2020.
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, as noted above.
About Acasti
Acasti is a biopharmaceutical innovator
advancing a potentially best-in-class cardiovascular drug, CaPre,
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 potential exists to expand the treatable
market in the United States to the approximately 50 million people
with TGs above 150 mg/dl, given the recent FDA approval of expanded
labeling for VASCEPA based on the recent positive REDUCE-IT outcome
study results. 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;
CaPre’s potential to become the “best-in-class” cardiovascular drug
for treating severe Hypertriglyceridemia; the timing and outcome of
the unblinding of TRILOGY 2; and Acasti’s ability to file an NDA
based on the results of its TRILOGY Phase 3 program.
The forward-looking statements contained in this
press release are expressly qualified in their entirety by this
cautionary statement, the “Special Note Regarding Forward-Looking
Statements” section contained in Acasti’s latest annual report on
Form 10-K, which will be available on EDGAR at
www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com 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 10-K under the caption “Risk Factors”.
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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