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, or HTG (triglyceride blood levels from
500 mg/dL to 1500 mg/dL), today announced that a detailed
examination of the Phase 3 TRILOGY 1 results for CaPre is
underway, including specific clinical site audits and an audit of
the central testing laboratory.
As previously reported, the Company noted a
highly unusual placebo response in its topline triglyceride
reduction primary endpoint, far greater than seen in any prior
omega-3 triglyceride lowering trials, with 5 sites out of the total
54 enrolling sites disproportionately contributing to this placebo
response. These sites accounted for about 36% of the 242 patients
enrolled in the TRILOGY 1 study. By comparison, TRILOGY 2 was
conducted at 71 sites in Canada, Mexico and the United States that
enrolled a total of 278 patients. The 5 sites also participated in
TRILOGY 2, however these sites accounted for only 12% of the total
patients, with the majority of these patients coming from only 3
sites.
Despite monitoring activities conducted
throughout the TRILOGY 1 trial to ensure adherence to the protocol
and identify protocol violations, the Company has subsequently
identified some unexpected and inconsistent findings that it
believes may have negatively contributed to the overall topline
results. These findings are now being further explored via a
comprehensive and rigorous review of data and patient medical
records by an independent team of auditors. To support this effort,
the Company, its independent Clinical Research Organization (CRO)
that conducted the TRILOGY studies, its principal investigator Dr.
Mozaffarian, and other clinical and regulatory advisors, are
conducting a thorough review of all data and records from patients
taking both CaPre and placebo. This assessment is well underway,
and the Company has also determined that a thorough investigation
of the data must be completed and reviewed with the FDA, before the
Company can report the findings from TRILOGY 1 and the implications
for TRILOGY 2.
Consequently, the Company intends to request a
meeting with the FDA to discuss the TRILOGY 1 data, and will seek
their guidance about how to conduct the analysis of the TRILOGY 2
data prior to unblinding TRILOGY 2. The Company continues to remain
blinded to the TRILOGY 2 data. Upon submission of the meeting
request, which is expected to be sent to the FDA in calendar Q2,
2020, the FDA will have 75 days to review the findings and provide
feedback and guidance.
Given the need to complete the audit and review
of the TRILOGY 1 data, and obtain FDA feedback, the Company now
anticipates the unblinding of the topline results for TRILOGY 2
sometime in calendar Q3 of 2020. Acasti will provide further
guidance as to the timing of reporting TRILOGY 2 data based on
progress of the audits and feedback from the FDA. Accordingly, key
secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY
2 studies, would now be expected as soon as possible after the
unblinding of TRILOGY 2 results.
If the interpretation of the analyses produced
as an outcome of the audits and post-hoc data review are supported
by the FDA, and if TRILOGY 2 achieves statistical significance,
Acasti believes it may still have a viable path forward to file an
NDA for CaPre.
Jan D’Alvise, president and CEO of Acasti
Pharma, stated, “Taking into account that the audit is still
underway, that the data that we are evaluating is still
preliminary, and that any findings will be subject to guidance from
the FDA, we look forward to concluding the necessary work, which we
hope will help us to better understand the unexpected TRILOGY 1
results. While we regret the additional delay in reporting TRILOGY
2 results, given our initial findings, we believe it is critical to
conduct a thorough investigation and evaluation of the TRILOGY 1
results. Any learnings we can take from this investigation that may
allow us to proactively adjust the SAP for TRILOGY 2, gives us a
better chance of accurately reflecting the clinical value that we
believe we still see in CaPre. Moreover, we have confirmed that
there is established precedent for the FDA accepting post-hoc
analyses of study results, assuming the analyses are transparent,
well justified and well supported. We are moving as quickly
as possible to gain a greater understanding of the TRILOGY 1
results, and will provide material updates as we learn more
information. Furthermore, we project that our current cash
position will now last through calendar 2020, giving us the
necessary runway to complete our extended analysis of the TRILOGY
program. We remain fully committed to our goal of gaining NDA
approval for CaPre, and appreciate the tremendous support and
patience of our shareholders.”
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. 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 200mg/dl and 500mg/dl) to patients with severe
hypertriglyceridemia (those with TG levels above 500mg/dl).
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, as noted above.
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 potential exists to expand
the treatable market in the United States to the approximately 50
million people with TGs above 150 mg/dl, given the recent FDA
approval of expanded labeling for VASCEPA based on the recent
positive REDUCE-IT outcome study results. 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 to fund its continued operations,
CaPre’s potential to meet or exceed the target primary endpoint of
reducing triglycerides by 20% compared to placebo, Acasti’s ability
to report topline results for TRILOGY 2 within the contemplated
timing as well as Acasti’s ability to report key secondary and
exploratory endpoints from both TRILOGY studies within the
contemplated timing, and Acasti’s ability to file an NDA based on
the TRILOGY studies.
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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