Apabetalone expands to a second major clinical
indication in kidney dialysis patients
CALGARY, May 15, 2017 /CNW/ - Resverlogix Corp.
("Resverlogix" or the "Company") (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.
About Resverlogix
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).
Follow us on Twitter:
@Resverlogix_RVX (https://twitter.com/resverlogix_rvx), or on
our blog at http://www.resverlogix.com/blog
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
Or visit our website: www.resverlogix.com
SOURCE Resverlogix Corp.