Patient enrollment in the United States is expected to commence this quarter
Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX:RVX) and the Resverlogix BETonMACE Clinical Steering Committee (CSC), represented by Professor Kausik Ray (Chair), are pleased to announce the FDA acceptance of the Company’s Phase 3 BETonMACE trial Protocol amendments.
On behalf of all members of the BETonMACE CSC, Professor Kausik Ray welcomed the addition of US-based sites to the ongoing cardiovascular disease (CVD) outcomes trial, BETonMACE. The BETonMACE trial will now be expanded beyond Europe, Asia and South America to a fourth continent – North America with the addition of the United States. Prof. Ray commented, “The addition of the United States is timely as we plan to conduct a Sample Size Recalculation Analysis (‘SSRA’) later in the first half of 2018. BETonMACE is currently targeted to include 2,400 participants to yield 250 MACE events and this number may be increased if required. Enrolling patients from the major regions of the world will provide evidence of generalizability in different healthcare systems and in different populations should apabetalone show improvement in cardiovascular outcomes. The FDA acceptance of the BETonMACE trial in US centers is an important milestone in the development of this compound.”
Further, Mr. Donald McCaffrey, President and Chief Executive Officer, stated, “I am extremely pleased with the continued progress of the BETonMACE trial. We have already enrolled over 2,200 patients and expanding territories and potentially number of patients beyond 2,400 may be beneficial in several ways, scientifically and commercially. BETonMACE top line data is still planned to be available around the end of 2018.”
About BETonMACE and the Clinical Steering Committee
The CSC is responsible for oversight and strategic direction for the Company’s Phase 3 BETonMACE trial. The BETonMACE study, “Effect of RVX-208 on Time to Major Adverse Cardiovascular Events (MACE) in High-Risk Type 2 Diabetes Mellitus Subjects with Coronary Artery Disease,” commenced in October 2015. The study is a large international multicenter, double-blind, randomized, parallel group, placebo-controlled clinical trial to determine whether treatment with apabetalone in combination with rosuvastatin or atorvastatin increases the time to MACE compared to treatment with rosuvastatin or atorvastatin alone. The primary endpoint of the BETonMACE trial is designed to show a relative risk reduction of MACE, narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction (“MI”) and stroke. The study is an event-based trial and will continue until at least 250 MACE events have occurred.
The study will ultimately contain at least 2,400 patients in 14 participating countries.
Members of the CSC include:
- Professor Kausik Ray (Chair), BSC (HONS), MBCHB, MD, MPHIL (CANTAB), FACC, FAHA, FESC, FRCP – Imperial College London, London, UK.
- Dr. Henry N. Ginsberg, MD, FAHA – Columbia University College of Physicians and Surgeons, New York, NY.
- Dr. Kamyar Kalantar-Zadeh, MD, MPH, PHD, FAAP, FACP, FASN, FAHA, FNKF – UC Irvine School of Medicine, Irvine, CA.
- Professor Stephen J. Nicholls, MBBS, PHD – University of Adelaide, Adelaide, AUS.
- Dr. Gregory G. Schwartz, MD, PHD – University of Colorado, Denver, CO.
- Dr. Peter P. Toth, MD, PHD, FAAFP, FICA, FAHA, FNLA, FCCP, FACC – University of Illinois School of Medicine, Chicago, IL.; Johns Hopkins University School of Medicine, Baltimore, MD.
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 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 the only selective BET bromodomain inhibitor in human clinical trials. 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 enrollment of US patients in BETonMACE, the estimated availability of top line data from the BETonMACE clinical trial, 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, 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.