Acasti Pharma Reports Topline Triglyceride Results from Phase 3 TRILOGY 2 Study of CaPre in Patients with Severe Hypertriglyc...
August 31 2020 - 7:00AM
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 top-line results for the
Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from
its 278 patient Phase 3 TRILOGY 2 study evaluating the efficacy,
safety and tolerability of CaPre in patients with severe
hypertriglyceridemia.
The Company reported a 30.4% median reduction in
triglyceride levels among all patients receiving CaPre, as compared
to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride
levels among patients receiving placebo at 12 weeks (the Primary
Endpoint), as compared to 27.5% in TRILOGY 1. The unadjusted,
placebo corrected triglyceride reduction of 12.4% achieved a “p”
value of 0.19, which was not statistically significant, and
therefore the TRILOGY 2 study did not meet its primary endpoint. As
a result, the company will not file a New Drug Application (NDA)
with the U.S. Food and Drug Administration (FDA) for patients with
severe hypertriglyceridemia, and does not plan to conduct
additional clinical trials for CaPre.
CaPre was well tolerated in TRILOGY 2, with a
safety profile similar to placebo, and consistent with the
Company’s previously conducted Phase 2 and 3 studies.
“Compared to their baseline levels, the observed
triglyceride reductions among patients taking CaPre were similar or
larger than seen with prior omega-3 therapies,” said Dr. Dariush
Mozaffarian, Professor at Tufts University and academic PI of the
trial. “However, an unusual reduction in triglyceride levels in the
placebo group meant that statistical significance was not achieved.
We plan to now pool together the results from the two studies to
see if we can better understand this phenomenon in post-hoc
explorations. We want to thank all of the investigators for their
participation, and Acasti for sponsoring the Trilogy program.”
Jan D’Alvise, Chief Executive Officer of Acasti,
stated, “We are very disappointed in the outcome of the Trilogy 2
study. Based on what we have seen in the preliminary topline data,
we believe TRILOGY 2 was likely not affected by the same
“Pre-Randomization Triglyceride Normalization” effect that we saw
in TRILOGY 1. While the triglyceride reduction observed in the
control arm was less than what was observed in the Trilogy 1 Study,
it still remains one of the highest seen amongst the previously
conducted triglyceride reduction studies, and may be explained by
the excellent background standard of care that is being provided to
these patients today.”
D’Alvise continued, “We extend our sincere
gratitude to all of the patients and their families, as well as the
investigators who participated in this important trial, and to our
employees who have worked tirelessly to develop and evaluate CaPre
as a therapeutic for this indication. We especially want to thank
Dr. Dariush Mozaffarian, our Principal Investigator, for his expert
counsel and support throughout this program. The Acasti team and
our clinical advisors will review the full dataset once it is
available, and will complete the full data analyses as contemplated
in the Statistical Analysis Plan, including the secondary and
exploratory endpoints and the pooling of the data from TRILOGY 1
and 2. Taking into consideration all of the analyses from TRILOGY
once completed, we will seek to maximize the value of the
CaPre® asset by continuing to explore a range of options available
to us.”
The Company has decided not to host a conference
call today as previously disclosed, as there is no additional
material information at this time that can be shared beyond what is
contained in this press release. The Company and its board of
directors has been and will continue to evaluate all strategic
options and will provide updates on this process as warranted.
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, its review of strategic options, potential value
for CaPre®, prospects and the plans of management.
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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