FREMONT, Calif. and
WALTHAM, Mass., July 29, 2021 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), a biopharmaceutical company focused on the
discovery, development, and commercialization of innovative
first-in-class medicines to improve treatment for people with
kidney and cardiorenal diseases, today announced that it has
received a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) regarding the company's New Drug
Application (NDA) for tenapanor for the control of serum phosphorus
in adult patients with chronic kidney disease (CKD) on
dialysis.
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According to the CRL, while the FDA agrees that "the submitted
data provide substantial evidence that tenapanor is effective in
reducing serum phosphorus in CKD patients on dialysis," they
characterize the magnitude of the treatment effect as "small and of
unclear clinical significance." Additionally, the FDA noted that
for the application to be approved, Ardelyx needs "to conduct an
additional adequate and well-controlled trial demonstrating a
clinically relevant treatment effect on serum phosphorus or an
effect on the clinical outcome thought to be caused by
hyperphosphatemia in CKD patients on dialysis." There were no
safety, clinical pharmacology/biopharmaceutics, CMC or non-clinical
issues identified in the CRL.
The FDA indicated it is willing to meet with Ardelyx to
discuss options for obtaining approval. To that end, the
company intends to request a Type A meeting as soon as possible to
discuss the CRL and determine potential paths forward for the
approval of tenapanor for the control of serum phosphorus in
adult patients with CKD on dialysis.
"We are saddened by this communication from the FDA and what it
means for the patients and the physicians who treat them," said
Mike Raab, president and chief
executive officer of Ardelyx. "We continue to believe tenapanor
represents an important, first-in-class treatment option for
patients with elevated phosphorus. We do not agree with the FDA's
subjective assessment on the clinical relevance of the treatment
effect of tenapanor in our studies which met all clinical endpoints
agreed upon by the FDA. In our view, the serum phosphorus lowering
data generated with tenapanor in all of our clinical studies is
meaningful and clinically significant. We will work with the
agency to address the issues raised and, to the extent possible,
find an expeditious path forward."
Arnold Silva, M.D., Ph.D.,
director of Clinical Research at Boise Kidney and Hypertension
Institute, added, "Lowering serum phosphorus is a priority for me
in managing my patients on dialysis, and is an established standard
of care driven by the peer-reviewed globally accepted KDIGO
clinical practice guidelines. Years of research have demonstrated
the negative consequences associated with even slight elevations in
serum phosphorus. Despite our best efforts with currently available
therapies, managing phosphorus remains a significant
challenge. We need new tools. I've closely followed the
extensive clinical development of tenapanor, not only as an
interested nephrologist, but also as a clinical investigator. I've
seen the clinical benefits of tenapanor first-hand in my patients
and I'm stunned that the FDA is not granting approval of this novel
mechanism drug, despite extensive clinical data demonstrating its
safety and efficacy."
"Neither peritoneal nor hemodialysis provides adequate control
of serum phosphorus, obligating the use of medications," said
Glenn Chertow, M.D., M.P.H.,
division chief of nephrology and professor of medicine at
Stanford University. "Unfortunately,
phosphate binders – individually or in combination – rarely yield
consistent control of serum phosphorus concentrations, and
persistent hyperphosphatemia leads to dystrophic calcification,
accelerated arteriosclerotic vascular disease, fractures, and other
complications that profoundly affect patients' lives. The effect of
tenapanor on serum phosphorus observed in the Phase 3 trials is
clinically meaningful. Tenapanor would enable a substantially
larger fraction of patients to reach target serum phosphorus
concentrations and would yield significant clinical benefit to this
vulnerable population."
The NDA for tenapanor for the control of serum phosphorus is
supported by a comprehensive development program involving more
than 1,000 patients and included three Phase 3 clinical trials, all
of which met their primary and key secondary endpoints.
At the end of the second quarter ended June 30, 2021, Ardelyx had $171.8 million in cash and cash equivalents
(unaudited).
Conference Call Details
The company will host a conference call today, July 29, 2021, at 5:00 PM
ET to discuss today's announcement. To participate in the
conference call, please call (855) 296-9612 (toll-free) or (920)
663-6277 (toll) and reference call ID number 6823689. A webcast of
the call can also be accessed by visiting the Investor page of the
company's website www.ardelyx.com and will be available on the
website for 30 days following the call.
About Ardelyx, Inc.
Ardelyx is focused on discovering, developing and
commercializing innovative first-in-class medicines to enhance the
lives of patients with kidney and cardiorenal diseases. Ardelyx is
developing tenapanor, a novel product candidate to control serum
phosphorus in adult patients with CKD on dialysis, which has
completed three successful Phase 3 trials. Ardelyx is also
advancing RDX013, a potassium secretagogue, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and has an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. In addition, Ardelyx received FDA
approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established
agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and
commercialization of tenapanor in their respective territories.
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 Ardelyx's
expectation with regard to its interactions and communications with
the FDA and its plans and expectations as to the possibility of a
pathway to approval of tenapanor for the control of serum
phosphorus in adult patients with chronic kidney disease patients
on dialysis. Such forward-looking statements involve substantial
risks and uncertainties that could cause 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, whether the company will
be able to address the deficiencies identified by the FDA, whether
additional trials will be necessary and if so, the scope of those
trials. 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 May 6,
2021, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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SOURCE Ardelyx