Resverlogix Announces Seventh Positive Recommendation From The Data Safety Monitoring Board For Phase 3 Study of Apabetalone
August 07 2018 - 7:00AM
Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today
announced that the independent Data and Safety Monitoring
Board (DSMB) for the Company's Phase 3 BETonMACE trial in high-risk
cardiovascular disease (CVD) patients has completed a seventh
planned safety review and recommended that the study should
continue as planned without any modifications. The DSMB reviewed
available study data and noted that no safety or efficacy concerns
were identified, and will conduct additional periodic reviews.
Resverlogix, the clinical steering committee, and all investigators
remain blinded to the trial data.
"The DSMB has now had the opportunity to review
data from all of the target 2,400 patients recruited to the
BETonMACE study and have not identified any safety issues. There
are now sufficient patients recruited to BETonMACE to yield 250
MACE events and we look forward to study completion," stated Dr.
Michael Sweeney, M.D., Senior Vice President of Clinical
Development.
BETonMACE
Apabetalone (see description below) is currently
being studied in a Phase 3 trial, BETonMACE, in high-risk CVD
patients with type 2 diabetes mellitus and low levels of
high-density lipoprotein. The primary endpoint of the BETonMACE
trial is designed to establish a relative risk reduction of Major
Adverse Cardiac Events, narrowly defined as a single composite
endpoint of cardiovascular death, non-fatal myocardial infarction
or stroke. In BETonMACE, two additional pre-specified endpoints
will be captured, the first being renal function. Approximately 11%
of the participants in the study will also have Stage 3 chronic
kidney disease, which is defined by an estimated glomerular
filtration rate below 60 at baseline. Additionally, pre-specified
analysis of cognitive function will take place in approximately 18%
of the study participants aged 70 and older. Cognitive function
will be assessed using the Montreal Cognitive Analysis (MoCA). This
group will be tested in the following categories: those with a
baseline MoCA of 26 or above, deemed cognitively normal, and those
with a baseline MoCA of 25 or below, defined as those who have some
form of cognitive disorder.
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.
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 Company's Phase 3 clinical
trial and the potential role of apabetalone in the treatment of
CVD, DM, chronic kidney disease, end-stage renal disease treated
with hemodialysis, Alzheimer's disease, Fabry disease, and 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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