"BETonMACE Phase 3 Trial with apabetalone to
expand to include the United
States"
CALGARY, July 25, 2017 /PRNewswire/ - 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
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 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
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.
SOURCE Resverlogix Corp.