Resverlogix Announces FDA Confirmation Regarding Filing Pathway for Apabetalone
June 14 2018 - 3:20PM
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX)
announced today that it has received confirmation from the U.S.
Food and Drug Administration (“FDA”) that BETonMACE, Resverlogix’s
on-going Phase 3 study, if successful, is likely to support the
filing and approval of a New Drug Application (“NDA”). The
statistical analysis plan and endpoints proposed by the Company
were reviewed and accepted by the Division of Cardiovascular and
Renal Products (“DcaRP”) of the FDA. The exact indication to be
sought by the Company, and to be reviewed by the FDA, would be
driven by the study’s results.
The ongoing Phase 3 BETonMACE trial has enrolled
its planned target of over 2,400 patients. The trial patients are
high-risk cardiovascular disease (“CVD”) patients with type 2
Diabetes Mellitus (“DM”) and low levels of high-density lipoprotein
(“HDL”) who have recently (within 7-90 days) experienced an acute
coronary syndrome (myocardial infarction or unstable angina). These
patients are at very high CVD risk despite standard of care
treatment. The primary endpoint of the BETonMACE trial is designed
to establish a relative risk reduction (“RRR”) of Major Adverse
Cardiac Events (“MACE”), narrowly defined as a single composite
endpoint of cardiovascular death, non-fatal myocardial infarction
or stroke. BETonMACE is an event-driven trial, and with recruitment
complete, continues to accumulate MACE towards the required
number.
“We are excited to receive feedback from the FDA
that confirms the path forward for filing of an NDA for
apabetalone, the first selective BET inhibitor for the treatment of
high-risk cardiovascular disease. The FDA’s feedback is similar to
that received previously from European authorities. We are now
focused on completing the BETonMACE study together with other
activities required for NDA and Marketing Authorisation Application
(“MAA”) filings,” stated Donald McCaffrey, President and CEO of
Resverlogix.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208),
a first-in-class, small molecule that is a selective BET
(bromodomain and extra-terminal) inhibitor. BET bromodomain
inhibition is an epigenetic mechanism that can regulate
disease-causing genes. Apabetalone is a BET inhibitor selective for
the second bromodomain (BD2) within the BET proteins. This
selective inhibition of apabetalone on BD2 produces a specific set
of biological effects with potentially important benefits for
patients with high-risk cardiovascular disease, diabetes mellitus,
chronic kidney disease, end-stage renal disease treated with
hemodialysis, neurodegenerative disease, Fabry disease, peripheral
artery disease and other orphan diseases, while maintaining a well
described safety profile. Apabetalone is currently being studied in
a Phase 3 trial, BETonMACE, in high-risk CVD patients with type 2
DM and low levels of high-density lipoprotein (HDL). In BETonMACE
approximately 11% of the participants have chronic kidney
disease.
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX:RVX).
Follow us on Twitter: @Resverlogix_RVX
For further information please contact:
Investor Relations Email:ir@resverlogix.com Phone:
403-254-9252Or visit our website: www.resverlogix.com
This news release may contain certain
forward-looking information as defined under applicable Canadian
securities legislation, that are not based on historical fact,
including without limitation statements containing the words
"believes", "anticipates", "plans", "intends", "will", "should",
"expects", "continue", "estimate", "forecasts" and other similar
expressions. In particular, this news release includes forward
looking information relating to the BETonMACE study, the filing and
approval of an NDA and/or MAA, and the potential role of
apabetalone in the treatment of CVD, DM, chronic kidney disease,
end-stage renal disease treated with hemodialysis,
neurodegenerative disease, Fabry disease, peripheral artery disease
and other orphan diseases. Our actual results, events or
developments could be materially different from those expressed or
implied by these forward-looking statements. We can give no
assurance that any of the events or expectations will occur or be
realized. By their nature, forward-looking statements are subject
to numerous assumptions and risk factors including those discussed
in our Annual Information Form and most recent MD&A which are
incorporated herein by reference and are available through SEDAR at
www.sedar.com. The forward-looking statements contained in this
news release are expressly qualified by this cautionary statement
and are made as of the date hereof. The Company disclaims any
intention and has no obligation or responsibility, except as
required by law, to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Resverlogix (TSX:RVX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Resverlogix (TSX:RVX)
Historical Stock Chart
From Apr 2023 to Apr 2024