Resverlogix Exceeds Full Enrollment for the Pivotal Phase 3 BETonMACE Clinical Trial
The BETonMACE trial has now surpassed 2,400 enrolled patients and topline data is expected around the end of 2018
CALGARY, Alberta, March 19, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that it has successfully surpassed the planned enrollment target of over 2,400 patients in the ongoing Phase 3 BETonMACE trial. The trial's first patient was enrolled on November 11th, 2015. The goal of the trial is to confirm the effect of Resverlogix' lead drug, apabetalone, in Cardiovascular Disease (CVD) patients with type 2 Diabetes Mellitus (DM) and low high-density lipoproteins (HDL). The primary endpoint of the BETonMACE trial is designed to establish a relative risk reduction (RRR) of Major Adverse Cardiac Events (MACE), narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) and stroke. Secondary pre-specified endpoints in the trial will also examine renal function and MACE in patients with chronic kidney disease (CKD) Stage 3 as well as cognition, measured by the Montreal Cognitive Assessment (MoCA) in all patients aged 70 and over.
"Achieving full enrollment early leaves two major clinical reflection points that will transpire in 2018. The first will be attaining 75% percent of our targeted 250 MACE events, being 188 events in total, thus allowing us the ability to conduct a sample size re-estimation analysis assuring that the trial will be sufficiently powered to confirm relative risk reduction," stated Donald McCaffrey, President and Chief Executive Officer. "The second major reflection point will be the most important, the Primary Endpoint read-out around the end of 2018. This read-out will prove pivotal in planning our FDA and EMA registration applications. We are exploring the option of US enrollment in the BETonMACE trial as well as the option of relying on existing BETonMACE data to file a US New Drug Application (NDA). It is management's belief that the determining factor for all approvals will be based on the strength of the final BETonMACE data. We will wait until the data roll-out before updating any proposed drug registration timelines," added Mr. McCaffrey.
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 chronic 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 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).
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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 timing of significant milestones for the Phase 3 BETonMACE clinical trial, Phase 2a kidney dialysis clinical trial and Fabry Disease clinical trial, the Company's intention to raise additional capital and pursue licensing opportunities , 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.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Resverlogix Corp via Globenewswire
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