A data review by the independent Data Safety Monitoring Board resulted in a recommendation for the BETonMACE trial to continue as planned without any modification
CALGARY, Alberta,, Aug. 07, 2018 (GLOBE NEWSWIRE) -- 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.
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.
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.
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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.