Resverlogix’s Apabetalone Demonstrates a Medical First in Patients with Chronic Kidney Disease
April 27 2021 - 1:41PM
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX)
announced today the recent publication of an article titled:
“Effect of Apabetalone on Major Adverse Cardiovascular Events in
Patients with Chronic Kidney Disease, Type-2 Diabetes Mellitus and
Recent Acute Coronary Syndrome: Results from the BETonMACE
Randomized Controlled Trial”, in the high-impact, peer-reviewed
Clinical Journal of the American Society of Nephrology. The article
was accompanied by a peer-reviewed editorial, published in the same
journal, titled: “Novel Therapeutic Options for Cardiovascular
Disease with CKD”.
The publication can be viewed HERE, and the
accompanying editorial HERE.
“To my knowledge this is the first time that a
cardiovascular risk reducing intervention – apabetalone – has shown
such an improvement in clinical outcomes in patients with chronic
kidney disease (CKD) – defined as an estimated glomerular
filtration rate of less than 60 mL/min/1.7m2 – in a randomized
placebo-controlled double-blind trial; and this is also the first
time that an epigenetic modulator in the form of an oral pill has
been studied in CKD,” stated Dr. Kam Kalantar-Zadeh of the
University of California Irvine, member of the BETonMACE Clinical
Steering Committee, and lead author of the paper. “In a
prespecified analysis of the BETonMACE study, patients with CKD
experienced significantly fewer major adverse cardiovascular events
when treated with apabetalone compared to placebo. These data
warrant further clinical research and development of apabetalone in
patients with high-risk CKD.”
In an editorial published alongside the new
research, Dr. Carmine Zoccali, and Dr. Francesca Mallamaci,
Nephrology Division, Grande Ospedale Metropolitano, Reggio
Calabria, Italy, contextualized these new findings, emphasizing the
unmet clinical need for patients suffering from diabetes and CKD,
and highlighting the potential of apabetalone to benefit this
group.
“All in all, apabetalone seems to be endowed
with a peculiar cardiovascular protection in patients for CKD,”
wrote Dr. Zoccali and Dr. Mallamaci in the editorial.
“The pronounced reduction in MACE seen in
BETonMACE CKD patients highlights the potential benefit these
patients could receive from apabetalone treatment,” said Donald
McCaffrey, President and CEO of Resverlogix. “Patients with CKD,
type-2 diabetes and established cardiovascular disease will be the
primary target patient population for our upcoming
registration-enabling study, BETonMACE2.”
Publication Highlights
include:
- In a pre-specified analysis in patients with CKD, participants
in the placebo group with CKD experienced double the incidence of
MACE (defined as cardiovascular death, nonfatal myocardial
infarction, stroke, and hospitalization for congestive heart
failure) than those without CKD
- Apabetalone treatment was associated with a 52% hazard
reduction for MACE events such as CVD death and Heart Failure,
compared to placebo (p=0.03); early and progressive separation in
events occurred between the two groups
- A statistically significant reduction in alkaline phosphatase,
a reported risk marker for CKD, was observed in patients with CKD
after 24 weeks of apabetalone treatment (p=0.004)
- In addition, fewer serious adverse events were also observed in
the apabetalone treated group compared to placebo (p=0.02)
Publication Background and
Conclusions:
Chronic Kidney Disease is associated with a high
burden of cardiovascular disease and poor clinical outcomes despite
current standard of care treatment options. This prespecified
analysis illustrated that treatment with apabetalone, in patients
with stage 3 or worse CKD, diabetes and a recent acute coronary
syndrome, was associated with a lower incidence of MACE. This
finding demonstrates that apabetalone may offer a safe and
effective treatment option for this high-risk group of patients.
Previously reported BETonMACE details can be found using the
following LINK.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208),
a first-in-class, small molecule that is a selective BET
(bromodomain and extra-terminal) inhibitor. Apabetalone is the
first therapy of its kind to have been granted US FDA Breakthrough
Therapy Designation – for a major cardiovascular indication – to
help facilitate a time-efficient drug development program including
planned clinical trials and plans for expediting the manufacturing
development strategy.
BET 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.
Resverlogix common shares trade on the Toronto
Stock Exchange (TSX:RVX).
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For further information please
contact:
Investor RelationsEmail:
ir@resverlogix.comPhone: 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 related to the Company’s registration-enabling
study – BETonMACE2 – and the potential role of apabetalone in the
treatment of 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. 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.
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