Acasti Pharma Provides Update on Timing of Topline Results for TRILOGY 1 Phase 3 Trial of CaPre
December 23 2019 - 8:31PM
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 (triglyceride blood levels from 500
mg/dL to 1500 mg/dL), today announced that it expects to report its
topline results for the TRILOGY 1 pivotal Phase 3 trial of CaPre in
January 2020. The reporting of Trilogy 1 was postponed due to an
unexpected delay in data processing and transfer from the central
testing laboratory to the statistical consultants for independent
and external validation. Acasti regrets the delay due to factors
outside its control, and now anticipates to report topline results
in January 2020. As requested by the Investment Industry
Regulatory Organization of Canada (IIROC), due to market
volatility, the Company indicates that it has no material update to
provide at this time beyond the above timing update and independent
and external validation exercise that is underway.
Implementation of the Trilogy 2 Study remains on
track, and the Company continues to expect the last patient to
complete their final visit in early January 2020, and expects to
report topline results in Trilogy 2 towards the end of January
2020.
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.
Safety and tolerability (e.g. overall adverse events (AE) and
serious AE rate, and any discontinuation due to AEs) will also be
reported. Other important secondary endpoints such as Non-HDL
cholesterol, HDL cholesterol, and VLDL may now also be reported
with the topline results. As previously disclosed, subgroup
analyses of certain key secondary (LDL) and exploratory markers
(HbA1c) will be dependent on combining results from both studies,
and would be expected sometime later in the first quarter of
2020.
NOVEMBER ATM DISTRIBUTION
UPDATE
Acasti also provided an update on its previously
adopted at-the-market program (the “ATM Program”) for the month of
November 2019, as required pursuant to the policies of the TSX
Venture Exchange (the “November ATM Distribution”). Pursuant to the
November ATM Distribution, Acasti issued an aggregate of 2,628,263
common shares of the Company (the “ATM Shares”) over the NASDAQ
Stock Market for aggregate gross proceeds to the Company of
US$5,693,057.27. The ATM Shares were sold at prevailing market
prices which ranged from US$2.05 per share to US$2.27 per share. No
securities were sold through the facilities of the TSX Venture
Exchange or, to the knowledge of the Company, in Canada. The ATM
Shares were sold pursuant to a U.S. registration statement on Form
F-3 (No. 333-223464) as made effective on March 16, 2018, as well
as an at-the-market issuance sales agreement dated February 14,
2019 among Acasti and B. Riley FBR, Inc. The ATM Shares sold
pursuant to the November ATM Distribution were the first securities
sold by Acasti under the ATM Program.
About
CaPre
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.
About Acasti Pharma
Acasti Pharma 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 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’spotential 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, Acasti’s ability to report to topline results
for TRILOGY 1 and TRILOGY 2 in January 2020 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.com
www.acastipharma.com
Investor
Contact:
Crescendo Communications, LLCTel:
212-671-1020Email: ACST@crescendo-ir.com
Acasti Pharma (NASDAQ:ACST)
Historical Stock Chart
From Mar 2024 to Apr 2024
Acasti Pharma (NASDAQ:ACST)
Historical Stock Chart
From Apr 2023 to Apr 2024