Resverlogix Announces FDA Confirmation Regarding Filing Pathway for Apabetalone
June 14 2018 - 03:25PM
CALGARY, Alberta, June 14, 2018
(GLOBE NEWSWIRE) -- 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: 403-254-9252
Or 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.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Resverlogix Corp via Globenewswire
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