More Than 40% of Patients Have Completed
Their 6 Month Treatment Plan
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 (HTG), today announced that the
Company’s two on-going Phase 3 TRILOGY trials (TRILOGY 1 and
TRILOGY 2) have exceeded a combined 89% patient randomization, and
more than 40% of the patients in both trials have completed their
6-month treatment plan. This means that the “last patient in” to
the TRILOGY 1 trial, will complete the trial by November. With the
expected approximate 1 month of data clean-up following the “last
patient out”, topline results for TRILOGY 1 are expected in
December.
Pierre Lemieux, Ph.D., COO and CSO of Acasti,
commented, “We are very pleased to announce that our two TRILOGY
Phase 3 trials are proceeding well and according to plan. We now
have reached 100% of the required total randomized patients for
TRILOGY 1 (245 patients), and 77% of the targeted number of
patients have been randomized in TRILOGY 2. We are also pleased to
report that there have been no severe adverse events associated
with our product, and we have experienced a lower drop-out rate
than anticipated, supporting the high safety profile and patient
acceptability of CaPre.”
Topline results will include readout of the
primary endpoint, which is CaPre’s overall impact on lowering
triglycerides. In addition, the topline results will include
CaPre’s impact on LDL and HDL cholesterol, non-HDL cholesterol, and
HbA1c, which is an important biomarker of glucose control in
diabetic patients.
Pierre Lemieux added, “Previous studies with
CaPre have shown its potential to improve glucose metabolism. We
expect that a significant number of the patients enrolled in the
TRILOGY studies will have diabetes with baseline HbA1c levels above
6.5. Therefore, there should be adequate patient numbers and data
to evaluate statistical evidence, if there is a clinically
meaningful effect from CaPre on HbA1C and/or other biomarkers of
long-term glucose intolerance. Since there is an increased risk
from the use of statins in diabetic patients with cardiovascular
risk factors, and given the fact hypertriglyceridemia is a major
risk factor for type 2 diabetes, beneficial effects of CaPre on
glycemic parameters could be advantageous and an important
differentiator versus other marketed omega-3 therapeutic
drugs.”
Jan D’Alvise, president and CEO of Acasti
Pharma, further noted, “We are very pleased with the progress of
the TRILOGY program, and appreciate the experienced leadership
provided by our CRO and Dr. Mozaffarian, our Principle
Investigator, and all of the investigators involved with these
trials at more than 150 clinical sites across the U.S., Canada, and
Mexico. Achieving 100% randomization on schedule is a major
milestone for TRILOGY 1, and we expect to attain the final
randomization target of 245 patients for TRILOGY 2 by the end of
next month. Consequently, we remain on track to report topline
results for TRILOGY 1 by the end of 2019, with topline results for
TRILOGY 2 within a few weeks thereafter. Full results for
both trials will be available as planned in Q1 of 2020.”
Acasti also announced today the annual grant of
stock options to its employees, executives and directors, and the
amendment of its stock option plan (the “Stock Option Plan”). The
stock options were granted by the Board of Directors as part of the
Company’s annual performance review in accordance with the
Company’s Long-Term Incentive Program (LTIP).
On April 15, 2019, an aggregate of 644,117 stock
options were granted to certain employees, executives and directors
of the Company under the Company’s Stock Option Plan. Subject to
the terms and conditions of the Stock Option Plan, options granted
to directors will vest in equal quarterly installments over a
period of 18 months and options granted to executives and employees
will vest in equal quarterly installments over a period of 36
months. Each option will entitle the holder to purchase one common
share of Acasti at a price of CDN$1.28, until April 15,
2029.
Subject to the approvals of the TSX Venture
Exchange and of shareholders at the Company’s next annual and
special meeting, on April 15, 2019, the Board of Directors amended
the Stock Option Plan in order to increase the current limit of
shares reserved for issuance under the plan, and also approved the
grant of an additional aggregate amount of 1,362,900 stock options
to executives and directors of the Company. Subject to the terms
and conditions of the amended Stock Option Plan, options granted to
directors will vest in equal quarterly installments over a period
of 18 months and options granted to executives will vest in equal
quarterly installments over a period of 36 months. Each option will
entitle the holder to purchase one common share of Acasti at a
price of CDN$1.28, until April 15, 2029. Pursuant to the
amendments, the limit of shares reserved for issuance under the
amended Stock Option Plan was increased from 5,494,209,
representing 15% of the issued and outstanding common shares of the
Company as of June 27, 2018, to 11,719,910, in order to maintain
the option pool at a fixed 15% of the issued and outstanding common
shares of the Company as of April 9, 2019.
About CaPre (omega-3
phospholipid)
Acasti Pharma’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 Pharma 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 Pharma’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. Acasti Pharma 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 Pharma 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
Pharma’s strategy is to commercialize CaPre in the U.S. and Acasti
Pharma 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 Pharma 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 Pharma’s
strategy, future operations, prospects and the plans of management;
Acasti Pharma’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, Acasti Pharma’s ability
to commercially launch CaPre, and, Acasti Pharma’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 Pharma’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 Pharma’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
Pharma 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 Pharma’s public securities filings with the
Securities and Exchange Commission and the Canadian securities
commissions, including Acasti Pharma’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’Alvise,
President and Chief Executive Officer Tel: 450-686-4555 Email:
info@acastipharma.com www.acastipharma.com
Investor Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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