FREMONT, Calif., Oct. 26, 2018 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), today announced the presentation of preclinical
data suggesting therapeutic synergy of tenapanor in combination
with sevelamer, the current standard-of-care phosphate binder
treatment for hyperphosphatemia, or elevated serum phosphorus. The
data, showing that the combination meaningfully reduced serum
phosphorus, were presented today in a poster titled "Combination
treatment with tenapanor and sevelamer synergistically reduces
urinary phosphorus excretion in rats," at the American Society of
Nephrology (ASN) Annual Meeting. Tenapanor, Ardelyx's lead product
candidate, is a sodium/hydrogen exchanger 3 (NHE3) inhibitor that
is currently being evaluated as a monotherapy in a second, Phase 3
registration trial, the PHREEDOM trial, for the treatment of
hyperphosphatemia in patients with end-stage renal disease (ESRD)
who are on dialysis. Data from that study are anticipated in
2019.
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The preclinical data presented today support Ardelyx's plans to
evaluate tenapanor in combination with phosphate binders in a
planned Phase 2/3 clinical trial. During the treatment period of
the planned Phase 2/3 combination trial, patients will remain on
their binders with either tenapanor or a placebo added to their
treatment regimen.
"If we are able to replicate what we've seen in these
preclinical studies in our planned human studies, we believe
tenapanor could be used as an add-on to current binder therapy,"
said David P. Rosenbaum, chief
development officer of Ardelyx. "Most dialysis patients have
phosphate levels that are significantly higher than normal, but to
date, the only options for treatment have been to add more
phosphate binders, which all have similar mechanisms of binding to
dietary phosphate in the gastrointestinal tract. Given the uniquely
different mechanism of tenapanor and its potential synergy with
phosphate binders, we could imagine nephrologists adding tenapanor
to the phosphate binder regimen of their patients, potentially
improving phosphate management and reducing the pill burden of
phosphate binders. We are excited to see if this effect is
supported by our planned human study."
In preclinical models, sevelamer was administered at three dose
levels with either tenapanor or placebo added twice daily for 11
days. Two additional groups received either tenapanor or placebo
alone. Results showed that in combination with tenapanor, sevelamer
dose-dependently decreased urinary phosphorus excretion and reduced
renal phosphorus clearance, resulting in a treatment effect that
was greater than either tenapanor or the equivalent dose of
sevelamer administered alone across all sevelamer dose levels, or
the expected additive reduction of the two treatments combined.
Treatment with tenapanor significantly decreased urinary sodium
excretion versus placebo, both when administered alone and when
co-administered with all doses of sevelamer. In addition, treatment
with tenapanor alone significantly reduced renal sodium clearance
versus placebo, a reduction that was not significantly affected by
combination treatment with sevelamer at the two lower doses.
Notably, the combination effect of tenapanor and sevelamer on
urinary phosphorus excretion was synergistic, with the strongest
synergy at the lowest and most clinically relevant sevelamer
dose.
About Ardelyx, Inc.
Ardelyx is focused on
enhancing the way people with cardiorenal diseases are treated by
developing first-in-class
medicines. Ardelyx's cardiorenal pipeline includes the
Phase 3 development of tenapanor for the treatment of
hyperphosphatemia in people with end-stage renal disease who are on
dialysis and RDX013, a potassium secretagogue program for the
potential treatment of high potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease. In
addition, Ardelyx has completed Phase 3 development of
tenapanor for the treatment of irritable bowel syndrome with
constipation (IBS-C) and submitted a New Drug Application to
the U.S. Food and Drug Administration seeking U.S.
marketing approval for this indication. To efficiently bring its
treatments to market, Ardelyx is pursuing strategic
collaborations for tenapanor for IBS-C and hyperphosphatemia in
certain territories. Ardelyx has established agreements
with Kyowa Hakko Kirin in Japan, Fosun Pharma
in China and Knight
Therapeutics in Canada. For more information, please
visit http://www.ardelyx.com/ and connect with us on
Twitter @Ardelyx.
Forward Looking Statements
To the extent that
statements contained in this press release are not descriptions of
historical facts regarding Ardelyx, they are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor of the Private
Securities Reform Act of 1995, including the potential for
Ardelyx's product candidates in treating the diseases and
conditions for which they are being developed, the potential for
the use of tenapanor in combination with phosphate binders as
adjunctive therapy for the treatment of hyperphosphatemia, and
Ardelyx's expected timing for receipt of data from its ongoing
Phase 3 clinical trial of tenapanor for the treatment of
hyperphosphatemia in ESRD patients. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
development of Ardelyx's product candidates or Ardelyx's future
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in the clinical development process, including the
regulatory approval process. Ardelyx undertakes no obligation to
update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to Ardelyx's business in
general, please refer to Ardelyx's Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on August 7, 2018, and its future current and
periodic reports to be filed with the Securities and Exchange
Commission.
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