Acasti Receives Full Data for Phase II TRIFECTA Trial
2015年3月2日 - 9:30PM
Acasti Pharma Inc. ("
Acasti" or the
"
Corporation") (Nasdaq:ACST) (TSX-V:APO), an
emerging biopharmaceutical company focused on the research,
development and commercialization of new krill oil-based forms of
omega-3 phospholipid therapies for the treatment and prevention of
certain cardiometabolic disorders, announces that it has received
full data for its Phase II double blind, placebo controlled
(TRIFECTA) trial.
The full set of data further confirms and supports the positive
Phase II TRIFECTA results announced in September 2014, on the
safety and efficacy of CaPre® in the treatment of patients with
hypertriglyceridemia. As previously announced, the TRIFECTA
trial's primary endpoint was met, with patients on 1 gram or 2
grams of CaPre® achieving a statistically significant mean
placebo-adjusted decrease in triglycerides from baseline. In
addition, benefits in other key cholesterol markers were announced,
including slight increases in HDL-C (good cholesterol), no
deleterious effect on LDL-C (bad cholesterol) and no safety
concerns.
With full data, Acasti is now able to meet with the US Food and
Drug Administration (FDA) to discuss next steps in the clinical
development of CaPre®. The meeting is expected to take place
in the Corporation's first quarter, ending May 31,
2015. "With the encouraging results announced to date,
we are well positioned to move forward with our clinical program,
including a pivotal Phase III trial for CaPre® in patients with
severe hypertriglyceridemia," said Pierre Lemieux, PhD, Acasti's
Chief Operating Officer. "In anticipation that we will
eventually receive approval to conduct a Phase III trial, we are
ramping up production of CaPre® clinical material, using current
Good Manufacturing Practices, to ensure a quality product in
sufficient quantities is available. This will allow us to
avoid any delays due to inventory shortages."
About Acasti Pharma Inc.
Acasti is an emerging biopharmaceutical company focused on the
research, development and commercialization of new krill oil-based
forms of omega-3 phospholipid therapies for the treatment and
prevention of certain cardiometabolic disorders, in particular
abnormalities in blood lipids, also known as dyslipidemia. Because
krill feeds on phytoplankton (diatoms and dinoflagellates), it is a
major source of phospholipids and polyunsaturated fatty acids
("PUFAs"), mainly eicosapentaenoic acid ("EPA") and docosahexaenoic
acid ("DHA"), which are two types of omega-3 fatty acids well known
to be beneficial for human health. CaPre®, currently Acasti's only
prescription drug candidate, is a highly purified omega-3
phospholipid concentrate derived from krill oil and is being
developed to help prevent and treat hypertriglyceridemia, which is
a condition characterized by abnormally high levels of
triglycerides in the bloodstream. ONEMIA®, a medical food and
currently Acasti's only commercialized product, is a purified
omega-3 phospholipid concentrate derived from krill oil with lower
levels of phospholipids, EPA and DHA content than CaPre®.
Forward Looking Statements
Statements in this press release that are not statements of
historical or current fact constitute "forward-looking statements"
within the meaning of the U.S. securities laws and Canadian
securities laws. 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," "will," or "plans"
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.
The forward-looking statements contained in this news release
are expressly qualified in their entirety by this cautionary
statement and the "Cautionary Note Regarding Forward-Looking
Information" section contained in Acasti's latest Annual
Information Form, which also forms part of Acasti's latest annual
report on Form 20-F, and which is 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 acastipharma.com (the
"AIF"). 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 other 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. Additional information about these
assumptions and risks and uncertainties is contained in the AIF
under "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.
CONTACT: Acasti Contact:
Andre Godin
Chief Financial Officer
+1.450.687.2262
a.godin@neptunebiotech.com
acastipharma.com
John Ripplinger
Investor Relations
+1.450.687.2262
j.ripplinger@acastipharma.com
acastipharma.com
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