FREMONT, Calif., Nov. 21, 2017 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX) today provided an update on the development of its
cardiorenal pipeline. The company's second registration study for
tenapanor for the treatment of hyperphosphatemia will begin
enrolling shortly, after having received feedback from the United
States Food and Drug Administration (FDA) on the trial design. In
addition, Ardelyx reported clinically meaningful potassium lowering
activity from its onset-of-action study for RDX7675 for the
treatment of hyperkalemia; however, the company also observed an
unexpected side effect of decreased serum bicarbonate. The company
believes this will limit the commercial potential of RDX7675 and,
as a result, has decided to discontinue development of RDX7675.
This change will result in a cash savings of approximately
$40 million to Ardelyx over the next
two years, extending the company's operating runway into 2019.
Hyperphosphatemia Program Update
As previously described, following learnings from Ardelyx's
first successfully completed Phase 3 study of tenapanor for the
treatment of hyperphosphatemia in end-stage renal disease (ESRD)
patients on dialysis, the company sought feedback from the FDA on
the design of its second Phase 3 registration study. Based on the
feedback recently received, the company will add an active control
arm to the study for safety assessment only, consistent with the
design of registration studies for phosphate binders. Ardelyx is
updating the study protocol and preparing to begin enrollment.
"If approved, tenapanor would be the first non-phosphate binder
treatment available for hyperphosphatemia in ESRD patients who are
on dialysis, who currently rely on highly burdensome and
difficult-to-take binders for treatment," said David P. Rosenbaum, Ph.D., chief development
officer of Ardelyx. "In the first Phase 3 study, tenapanor, with
just a few small pills, achieved the primary endpoint of
meaningfully reducing serum phosphorus and was well-tolerated. The
second Phase 3 trial is a crucial step toward advancing tenapanor
to the market, and we look forward to beginning enrollment. In our
view, tenapanor has the potential to dramatically improve
phosphorus management and change the way patients are treated."
Hyperkalemia Program Update
Ardelyx today reported an update from the company's
onset-of-action study for RDX7675 in patients with hyperkalemia.
The trial demonstrated that RDX7675 significantly reduced serum
potassium in patients treated across all dose levels. However, an
unexpected and drug-related reduction in serum bicarbonate was also
observed. Given the needs of this patient population, and the
requirement for a treatment that can be used in a chronic setting,
Ardelyx has made the decision to discontinue development of
RDX7675, including both the onset-of-action and Phase 3 studies.
Ardelyx will shift its hyperkalemia efforts to RDX013, its
earlier-stage, small-molecule program.
"The goal for RDX7675 was to develop a palatable product that
could be taken chronically to address an important medical need for
patients with hyperkalemia. We are pleased by the activity
observed; however, the unanticipated bicarbonate side effect
creates a barrier for RDX7675, which we believe could limit its
chronic use," said Mike Raab,
president and chief executive officer of Ardelyx. "It is our vision
to create novel, safe medicines that meet the needs of patients
underserved by today's treatments. We are very optimistic about the
future of our first-in-class pipeline. Tenapanor holds tremendous
potential in the indications we've studied, and we are working hard
to advance tenapanor for hyperphosphatemia and prepare for our New
Drug Application submission for IBS-C in the second half of 2018.
In addition, we have a number of promising earlier stage assets,
and we look forward to assessing the opportunity for RDX013 as a
non-binder for hyperkalemia."
Conference Call Information
The company will host a
conference call today, November 21, 2017 at 8:30
a.m. ET to discuss the update on its cardiorenal pipeline. To
participate in the conference call, please dial (855) 296-9612
(toll-free) or (920) 663-6277 (toll) and reference call ID number
5889997. A webcast of the call can be accessed by visiting the
Investor page of the company's website www.ardelyx.com, and
will be available on the website for 60 days following the
call.
About Ardelyx, Inc.
Ardelyx is focused on enhancing
the way patients with cardiorenal and gastrointestinal (GI)
diseases are treated by using the gut as the gateway to delivering
medicines that matter. The company has established unique
cardiorenal and GI business portfolios aimed at bringing new,
effective medicines with distinct safety and dosing advantages to
underserved patients. Ardelyx's portfolio 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. The company's GI portfolio
includes tenapanor for the treatment of people with irritable bowel
syndrome with constipation (IBS-C), for which the company
anticipates submitting a New Drug Application in the second half of
2018, and RDX8940, a TGR5 agonist. 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, and the expected
timing of the filing the NDA for tenapanor for the treatment of
IBS-C. 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
research and 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 November 7, 2017, and its future current and
periodic reports to be filed with the Securities and Exchange
Commission.
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SOURCE Ardelyx