Further validates prior study results
demonstrating that the bioavailability of CaPre is
significantly better than LOVAZA when taken with a low-fat meal
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 the publication
of a CaPre® bioavailability study, entitled “A Single-dose,
Comparative Bioavailability Study of a Formulation Containing OM3
as Phospholipid (PL) and Free Fatty Acid (FFA) to an Ethyl Ester
(EE) Formulation in the Fasting and Fed States,” which was
published in the March 2019 issue of Journal of Clinical
Therapeutics (Clinical Therapeutics 41 (2019) pp. 426-444), a
leading peer-reviewed journal in the field of clinical pharmacology
and therapeutics. The study publication is also available online
at:
https://www.clinicaltherapeutics.com/article/S0149-2918(19)30055-4/fulltext.
Acasti’s open-label, randomized, four-way,
cross-over, bioavailability study compared CaPre, given as a single
dose of 4 grams in fasting and fed states, with the approved
hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters or
OM3-EE) in 56 healthy volunteers. Among subjects in the fasting
state, CaPre demonstrated better bioavailability than LOVAZA, as
measured by blood levels of EPA and DHA.
The article concluded: “Among subjects in the
fasted state, the test product (CaPre) demonstrated greater
bioavailability of EPA and DHA in the form of free fatty acids and
esterified to phospholipids as compared to OM3-EE (reference
product). Bioavailability with OM3-EE was drastically reduced in
the fasted state compared to administration with a high-fat meal.
Since patients with severe HTG should adhere to a low-fat diet,
these findings suggest preserved exposure, and perhaps retained
efficacy, in patients taking OM3-PL/FFA in the fasted state or with
a low-fat diet.”
Dr. Robert Hegele, Director of the Blackburn
Cardiovascular Genetics Laboratory at Robarts Research Institute
and co-author of the study, commented, “With the renewed interest
in omega-3 fatty acids to reduce cardiovascular risk, it’s
important to evaluate similarities and differences between various
preparations. This study shows that bioavailability of CaPre
is less affected by dietary fat compared to another commonly used
form of omega-3. This might be important for clinical use in
treating patients with elevated blood lipids to prevent heart
attacks and strokes.”
Pierre Lemieux, Ph.D., COO and CSO of Acasti,
commented, “We are very pleased to have our study published in a
leading peer reviewed journal, which further validates the superior
bioavailability of CaPre when compared to the omega-3 ethyl ester
drug, LOVAZA, in conditions which we believe are more relevant for
patients with severe HTG . We also believe the unique combination
of EPA, DHA and phospholipids in CaPre’s composition contribute to
CaPre’s potential “trifecta effect,” by: (a) lowering
triglycerides; (b) reducing non-high-density lipoprotein
cholesterol (non-HDL-C) levels including LDL-C (“bad cholesterol”);
and (c) increasing high-density lipoprotein cholesterol (HDL-C)
(“good cholesterol”). With high rates of obesity and diabetes
fueling the number of patients with elevated triglycerides and
cholesterol, CaPre could fill the need for a best-in-class omega-3
medication that addresses the full lipid profiles of these
patients. We continue to make rapid progress on our TRILOGY Phase 3
trials, and based on current trends we remain on track to report
topline results before the end of this year.”
About CaPre (omega-3
phospholipid)
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. In two Phase 2 studies, CaPre achieved a statistically
significant reduction of triglycerides and non-HDL cholesterol
levels in patients across the dyslipidemia spectrum from patients
with mild to moderate hypertriglyceridemia (patients with TG blood
levels between 200 mg/dL [2.3 mmol/L] and 500 mg/dL [5.6 mmol/L])
to patients with severe hypertriglyceridemia (those with TG levels
above 500 mg/dL [5.6 mmol/L]). Furthermore, in the Phase 2 studies,
CaPre demonstrated the potential to actually reduce LDL, or “bad
cholesterol”, as well as the potential to increase HDL, or “good
cholesterol”, especially at the therapeutic dose of 4 grams/day.
The Phase 2 data also showed a significant reduction of HbA1c at a
4 gram dose, suggesting that due to its unique omega-3/phospholipid
composition, CaPre may actually improve long-term glucose
metabolism. Acasti’s TRILOGY 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. 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’s potential
to become the “best-in-class” cardiovascular drug for treating
severe Hypertriglyceridemia (HTG), Acasti’s ability to commercially
launch CaPre, 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
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