CALGARY, Alberta, July 25, 2017 /PRNewswire/ --
"BETonMACE Phase 3 Trial with apabetalone to expand to
include the United
States"
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) is
pleased to announce the receipt of a positive Type C written
response from the Division of Metabolism and Endocrinology Products
of the U.S. Food and Drug Administration (FDA). In light of updated
information regarding apabetalone, including: human exposure,
clinical dosing and established acceptable safety margins, the FDA
is allowing the Company to include United
States of America (USA)
patients in Phase 3 studies, including the BETonMACE trial.
Resverlogix has agreed to make adjustments to the existing
BETonMACE study protocol and to update the Investigator's Brochure
and the Informed Consent Documents. The primary objective of the
BETonMACE study is to evaluate if treatment with apabetalone in
addition to standard of care (SoC) as compared to placebo increases
time to the first occurrence of a major adverse cardiac event
(MACE) in high-risk cardiovascular disease patients with type 2
diabetes mellitus.
Mr. Donald McCaffrey, President
and CEO stated, "This is a major advancement for Resverlogix,
having Phase 3 trial approval from both the European Authorities
and FDA for apabetalone, which adds significant value to our
program. FDA approval to proceed with the Phase 3 BETonMACE trial
in the USA is well timed and
should not have a major impact on the total duration of the
BETonMACE trial." Mr. McCaffrey further commented, "This progress
is very encouraging and further validates our recently released
data that confirmed apabetalone's ability to differentially affect
genes and proteins between advanced chronic kidney disease (CKD)
patients and normal subjects."
Dr. Mike Sweeney, Senior Vice
President of Clinical Development stated, "We are pleased to now
have the opportunity to include USA patients in the global Phase 3 BETonMACE
clinical trial with approval from the FDA. The BETonMACE trial,
which commenced in 2015 via the European Authorities has been
progressing on target with over 70% enrollment with multiple
positive recommendations from the data safety monitoring board to
continue the trial as planned. We welcome the opportunity to
advance apabetalone in the USA."
About BETonMACE
In 2015, Resverlogix initiated a global Phase 3 clinical trial
called BETonMACE with apabetalone for the reduction of major
adverse cardiac events (MACE) in high-risk cardiovascular disease
patients with type 2 diabetes mellitus and low high-density
lipoprotein (HDL). The primary endpoint is to evaluate if treatment
with apabetalone as compared to placebo increases time to the first
occurrence of a major adverse cardiac event (MACE). MACE is
defined as a single composite endpoint of: cardiovascular
death, non-fatal myocardial infarction, or stroke. Secondary
endpoints include: revascularization and unstable angina; changes
in apolipoprotein A-I (apoA-I), apolipoprotein B (apoB),
low-density lipoprotein cholesterol (LDL-C), high-density
lipoprotein cholesterol (HDL-C), and triglycerides (TG); changes in
Hemoglobin A1c (HbA1c), fasting glucose, and fasting insulin; and
changes in alkaline phosphatase (ALP) and estimated
glomerular filtration rate (eGFR) in Stage 3 CKD patients.
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 the first and only BET inhibitor selective for the
second bromodomain (BD2) within the BET protein called BRD4. 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 (CVD), diabetes
mellitus (DM), 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 the
only selective BET bromodomain inhibitor in human clinical trials.
Apabetalone is currently being studied in a Phase 3 trial,
BETonMACE, in high-risk CVD patients with type 2 DM and low
high-density lipoprotein (HDL), and is expected to be initiated in
a Phase 2a kidney dialysis trial designed to evaluate biomarker
changes and safety parameters in up to 30 patients with end-stage
renal disease treated with hemodialysis.
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX:RVX).
Follow us on
Twitter: @Resverlogix_RVX (https://twitter.com/resverlogix_rvx),
or on our blog at http://www.resverlogix.com/blog
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 initiation of the Phase 3 BETonMACE
study in the USA, 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 http://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.
For further information please
contact:
Investor Relations
Email: ir@resverlogix.com
Phone: +1-403-254-9252
Or visit our website:http://www.resverlogix.com