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Resverlogix Announces Eighth Positive Data Safety Monitoring Board Recommendation For Phase 3 Study of Apabetalone
BETonMACE trial to continue as planned without modification
CALGARY, Alberta, Dec. 19, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today announces the independent Data and Safety Monitoring Board (DSMB) has completed an eighth planned safety review for the Company's Phase 3, BETonMACE trial for high-risk cardiovascular disease (CVD) patients and recommended the study continue without modification. The DSMB reviewed available safety data and commented that no safety concerns were identified. Resverlogix, the clinical steering committee, and all investigators remain blinded to the trial data.
"Following review of data from all 2,425 patients in the BETonMACE clinical trial, the DSMB concluded the study safe and recommended that we continue per protocol. We are now accruing the final events – to yield at least 250 pre-specified MACE events – prior 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 had Stage 3 chronic kidney disease at randomization, which is defined by an estimated glomerular filtration rate below 60 and higher than 30 mL/min/1.73 m2. Additionally, pre-specified analysis of cognitive function will take place in approximately 19% 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.
The BETonMACE trial is currently expected to be completed within the first half of calendar 2019, with third party adjudication of all MACE events anticipated to be available within two to three months past trial completion. The topline results of the study will be made available shortly thereafter.
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).
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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 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.