Resverlogix Corp(TSX:RVX) is pleased to announce the acceptance, by the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA), of the Company's Investigational New Drug (IND) application to commence a Phase 2a kidney dialysis trial. The primary objective of the study will be to evaluate if treatment with apabetalone in addition to standard of care (SoC) decreases alkaline phosphatase in comparison to placebo and SoC.
"We are thrilled to have received approval to investigate a second major indication along with FDA regulatory advancement for apabetalone at the same time. This is a very exciting prospect for Resverlogix's overall advancement. This progress is very encouraging and further validates our previously released data that confirmed apabetalone's ability to differentially affect genes and proteins between advanced chronic kidney disease (CKD) patients and normal subjects," stated Donald McCaffrey, President and CEO.
"Apabetalone and BET inhibition represent a truly novel approach to potentially impacting the extreme high risk of cardiovascular disease (CVD) events in this important patient population," stated Dr. Kamyar Kalantar-Zadeh, Chairman of Resverlogix's Renal Clinical Advisory Board. "We are excited to test apabetalone and the new science of epigenetics and BET inhibition on advanced CKD patients. These patients are in great need of novel approaches to reduce CVD risk", Dr. Kalantar-Zadeh further commented.
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.
About Advanced CKD & Dialysis
Advanced 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).
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
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