FREMONT, Calif. and
WALTHAM, Mass., Oct. 13, 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 the company
has met with the U.S. Food and Drug Administration (FDA) in a Type
A meeting, but was not provided sufficient clarity on what
constitutes "clinical relevance of the magnitude of treatment
effect" and continues to await additional information regarding the
path forward for 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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"Given that we have conducted the requisite registration
studies, which met all primary and key secondary endpoints with no
safety or other identified issues, we continue to be extremely
disappointed and surprised by the lack of clarity from the FDA on
the next steps to resubmit our NDA," said Mike Raab, president and chief executive officer
of Ardelyx. "In order to preserve our cash resources and
extend our cash runway, we have made the extremely difficult
decision to implement a restructuring plan that includes a
significant reduction in force. We have retained key employees
needed to continue to support the regulatory process and work to
achieve our goal to gain approval for tenapanor for
hyperphosphatemia. While a setback for our company, we believe the
delay in approval represents a more significant hardship for
patients who are being denied access to tenapanor, a much-needed,
novel therapeutic alternative with a different mechanism of action.
We remain dedicated to providing these underserved patients, of
which 77% are unable to maintain target phosphorus levels despite
active treatment with currently available therapies, another
treatment option."
The company announced that on October 12,
2021, it began implementing a restructuring plan to further
reduce operating costs and better align the company's workforce
with the needs of its business following the receipt of a complete
response letter (CRL) from the FDA on July
28, 2021, regarding the company's NDA for the control of
serum phosphorus in adult patients with CKD on dialysis, and the
results to date of the subsequent Type A meeting. The restructuring
plan is expected to be completed in December
2021. In connection with the restructuring, the company
estimates that it will incur aggregate restructuring charges of
approximately $2.3 million, which
will be recorded primarily in the fourth quarter 2021, related to
severance payments and other employee-related costs. The company
expects that the workforce reduction will decrease its annual cash
compensation costs by approximately $18.1
million. At the end of the third quarter ended September 30, 2021, Ardelyx had $141.7 million in cash and cash equivalents
(unaudited).
In July 2021, Ardelyx announced
that it had received a CRL from the FDA regarding the
company's NDA for tenapanor for the control of serum phosphorus in
adult patients with CKD on dialysis. 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.
While Ardelyx has yet to receive minutes from the Type A meeting
held October 1, 2021, the discussion
at the meeting did not provide clarification on the key
requirements: the FDA's definition of clinical significance and
relevant treatment effect.
About Hyperphosphatemia
Hyperphosphatemia is a serious condition resulting in an
abnormally elevated level of phosphorus in the blood that is
estimated to affect the vast majority of the 550,000 patients in
the United States with CKD on
dialysis. The kidney is the organ responsible for regulating
phosphorus levels, but when kidney function is significantly
impaired, phosphorus is not adequately eliminated from the body. As
a result, hyperphosphatemia is a nearly universal condition among
people with CKD on dialysis with internationally recognized KDIGO
treatment guidelines that recommend lowering elevated phosphate
levels toward the normal range (2.5-4.5mg/dL).
About Tenapanor for Hyperphosphatemia
Tenapanor, discovered and developed by Ardelyx, has a unique
mechanism of action and acts locally in the gut to inhibit the
sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption
through the paracellular pathway, the primary pathway of phosphate
absorption.
This novel blocking mechanism enables a one 30 mg tablet BID
dosing regimen. The most common side effect with tenapanor in
clinical trials was diarrhea.
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, tenapanor has already
received FDA approval for the treatment of irritable bowel syndrome
with constipation (IBS-C) under the tradename IBSRELA®. 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
statements regarding the expected costs associated with the
restructuring plan and the expected reduction in annual cash
compensation costs resulting from its workforce reduction. 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, uncertainties associated
with risks related to cost reduction efforts. In addition,
the company's workforce reduction costs may be greater than
anticipated. 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 13,
2021, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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SOURCE Ardelyx