Protocol comments and recommendations incorporated
CALGARY, Feb. 23, 2017 /CNW/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX: RVX) today announced the receipt of the final minutes of an in-person Type B meeting with the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to request written comments, recommendations and feedback on Resverlogix's proposed protocol for its Phase 2a kidney dialysis trial. The primary objective of the study will be to evaluate if treatment with apabetalone in combination with standard of care (SoC) decreases alkaline phosphatase in comparison to placebo and SoC.
In light of guidance received from the FDA, the Phase 2a study design will be separated in two parts. Part A will involve a single-dose pharmacokinetic (PK) study in eight patients receiving hemodialysis. The PK results from Part A will influence the dose selection for Part B. Part B will be a double-blind, randomized, placebo-controlled, sequential cross-over study with apabetalone, and is designed to evaluate biomarker changes and safety parameters with apabetalone in up to 30 patients with end-stage renal disease treated with hemodialysis. Resverlogix intends to file an official Investigative New Drug (IND) application and proceed with the planned Phase 2a clinical trial in 2017.
About Advanced CKD & Dialysis
Advanced Chronic Kidney Disease (CKD) encompasses CKD stages 4 & 5, and it can be alternatively defined as an estimated glomerular filtration rate (eGFR) of <30 ml/min/1.73m2. Reported in the 2016 United States Renal Data System (USRDS) Annual Report, approximately 1.4 million patients in the US have advanced CKD, 474,000 of which are on dialysis treatment. According to the USRDS, advanced CKD cost the US healthcare system approximately US$17 billion in 2014, with an average cost exceeding US$28,000 per patient. Additionally, dialysis treatment costs the US Medicare system approximately US$28 billion with an average cost exceeding US$80,000 per year. Currently there are no known agents that improve major adverse cardiovascular events (MACE) in CKD or dialysis 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, dialysis, Alzheimer's disease, Orphan diseases, and peripheral artery disease, while maintaining a well described safety profile. Apabetalone is the only selective BET bromodomain inhibitor in human clinical trials, currently in a Phase 3 trial BETonMACE in high-risk CVD patients with type 2 DM and low high-density lipoprotein (HDL).
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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 2a kidney dialysis trial and Phase 3 clinical trial, and the potential role of apabetalone in the treatment of CVD, DM, chronic kidney disease, Alzheimer's disease, Orphan diseases, and peripheral artery disease. 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.
SOURCE Resverlogix Corp.