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Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase 3 BETonMACE Trial
Calgary, Alberta (ots/PRNewswire) - "BETonMACE Phase 3 Trial with apabetalone to expand to include the United States"
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA). In light of updated information regarding apabetalone, including: human exposure, clinical dosing and established acceptable safety margins, the FDA is allowing the Company to include United States of America (USA) patients in Phase 3 studies, including the BETonMACE trial. Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol and to update the Investigator's Brochure and the Informed Consent Documents. The primary objective of the BETonMACE study is to evaluate if treatment with apabetalone in addition to standard of care (SoC) as compared to placebo increases time to the first occurrence of a major adverse cardiac event (MACE) in high-risk cardiovascular disease patients with type 2 diabetes mellitus.
Mr. Donald McCaffrey, President and CEO stated, "This is a major advancement for Resverlogix, having Phase 3 trial approval from both the European Authorities and FDA for apabetalone, which adds significant value to our program. FDA approval to proceed with the Phase 3 BETonMACE trial in the USA is well timed and should not have a major impact on the total duration of the BETonMACE trial." Mr. McCaffrey further commented, "This progress is very encouraging and further validates our recently released data that confirmed apabetalone's ability to differentially affect genes and proteins between advanced chronic kidney disease (CKD) patients and normal subjects."
Dr. Mike Sweeney, Senior Vice President of Clinical Development stated, "We are pleased to now have the opportunity to include USA patients in the global Phase 3 BETonMACE clinical trial with approval from the FDA. The BETonMACE trial, which commenced in 2015 via the European Authorities has been progressing on target with over 70% enrollment with multiple positive recommendations from the data safety monitoring board to continue the trial as planned. We welcome the opportunity to advance apabetalone in the USA."
In 2015, Resverlogix initiated a global Phase 3 clinical trial called BETonMACE with apabetalone for the reduction of major adverse cardiac events (MACE) in high-risk cardiovascular disease patients with type 2 diabetes mellitus and low high-density lipoprotein (HDL). The primary endpoint is to evaluate if treatment with apabetalone as compared to placebo increases time to the first occurrence of a major adverse cardiac event (MACE). MACE is defined as a single composite endpoint of: cardiovascular death, non-fatal myocardial infarction, or stroke. Secondary endpoints include: revascularization and unstable angina; changes in apolipoprotein A-I (apoA-I), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG); changes in Hemoglobin A1c (HbA1c), fasting glucose, and fasting insulin; and changes in alkaline phosphatase (ALP) and estimated glomerular filtration rate (eGFR) in Stage 3 CKD patients.
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).
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 initiation of the Phase 3 BETonMACE study in the USA, 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 http://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.