Resverlogix Receives Approval From the FDA Cardiovascular and Renal Division to Proceed With a Requested Apabetalone Clinical Trial

Calgary, Alberta (ots/PRNewswire) -

Apabetalone expands to a second major clinical indication in
kidney dialysis patients

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)
(https://twitter.com/resverlogix_rvx), or on our blog at
http://www.resverlogix.com/blog

ots Originaltext: Resverlogix Corp.
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Contact:
please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: +1-403-254-9252
Or visit our website: http://www.resverlogix.com

Original-Content von: Resverlogix Corp., übermittelt durch news aktuell