Acasti Provides Update on CaPre® Development Pathway
16 Diciembre 2015 - 6:50AM
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
positive feedback from the US Food and Drug Administration (FDA) on
the proposed development pathway for CaPre®.
“Recently, we received encouraging comments from
the FDA based on our briefing package submission indicating that
the 505(b)(2) pathway represents a course for regulatory review and
approval, and that Acasti’s plans for the bioavailability bridging
study are viewed as sound,” highlighted Pierre Lemieux, PhD,
Acasti’s Chief Operating Officer. “With this endorsement,
Acasti will submit an amendment to its current Investigational New
Drug (IND) application to commence a bridging study, while
continuing to work closely with the FDA to ensure the Corporation
is aligned with their views on CaPre® clinical development.”
As previously announced, the 505(b)(2) approval
pathway has been used by many other companies to secure approval
for a New Drug Application (NDA). Acasti’s regulatory and
clinical experts believe such a strategy is best for CaPre®.
The 505(b)(2) application also enables regulatory submission for a
New Chemical Entity (NCE) approval when some part of the data
application is derived from studies not conducted by the
applicant. It allows Acasti to further optimize the
advancement of CaPre®, including the Phase 3 protocol design, while
also benefiting from the substantial clinical and nonclinical data
already available with another FDA-approved omega-3 prescription
drug. In addition, it should reduce expenses, accelerate the
timing and streamline the overall development program required to
support a NDA submission.
Based on the proposed 505(b)(2) regulatory
pathway, Acasti is pursuing a pivotal bioavailability bridging
study, comparing CaPre® and another FDA-approved omega-3
prescription drug as a means of establishing a scientific bridge
between the two. This will help determine the feasibility of
a 505(b)(2) regulatory pathway, while also optimizing the protocol
design of a Phase 3 trial.
505(b)(2) Regulatory PathwayThe
505(b)(2) regulatory pathway is defined in The Federal Food Drug
and Cosmetics Act as a New Drug Application (NDA) containing
investigations of safety and effectiveness that are being relied
upon for approval and were not conducted by or for the applicant,
and for which the applicant has not obtained a right of reference.
These applications differ from the typical NDA (described under
Section 505(b)(1) of the Act), in that they allow a sponsor to
rely, at least in part, on the FDA’s findings of safety and/or
effectiveness for a previously approved drug.
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
StatementsStatements 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.
Acasti Contact:
John Ripplinger
Investor Relations
+1.450.687.2262
j.ripplinger@acastipharma.com
acastipharma.com
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