FREMONT, Calif. and
WALTHAM, Mass., Sept. 3, 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 the publication of
the company's long term 52-week Phase 3 PHREEDOM trial in the
American Society of Nephrology journal, Kidney360.
![Ardelyx logo (PRNewsFoto/Ardelyx) Ardelyx logo (PRNewsFoto/Ardelyx)](https://mma.prnewswire.com/media/119451/ardelyx_logo.jpg)
"The PHREEDOM trial, a 52-week randomized Phase 3 trial that
evaluated tenapanor monotherapy, was the third of three Phase 3
trials we conducted in our comprehensive evaluation of tenapanor
for the control of serum phosphorus in patients with chronic kidney
disease on dialysis," said Mike Raab, president and chief
executive officer of Ardelyx. "The PHREEDOM data demonstrate
the ability of tenapanor to provide significant phosphorus
reduction with long-term safety comparable to active control. This
study, together with data from our AMPLIFY trial which evaluated
tenapanor in combination with binders in patients who require more
aggressive phosphate management, supports the central role
tenapanor, with its novel blocking mechanism, can play across a
broad range of patients and treatment regimens for the management
of hyperphosphatemia in patients with chronic kidney disease on
dialysis."
Arnold Silva, M.D., Ph.D.,
director of Clinical Research at Boise Kidney and Hypertension
Institute, added, "As an investigator in this clinical trial and an
author on this publication, I have had the opportunity to see both
first-hand and in aggregate the impact of tenapanor on the control
of serum phosphorus. I believe this novel mechanism therapy
will play a key role in advancing the management of
hyperphosphatemia in our patients with CKD on dialysis, an area
where treatment options have been limited, and a significant
proportion of patients have phosphorus levels above target ranges
despite active treatment with currently available
therapies. Additionally, a one pill twice daily therapy that
blocks phosphorus absorption, whether used alone or in combination
with phosphate binders, has the potential to reduce treatment
burden, which will be a very meaningful benefit to patients."
About the PHREEDOM Study
PHREEDOM is a 52-week monotherapy trial that demonstrated a
clinically meaningful decrease in mean serum phosphorus in
tenapanor-treated patients from 7.7 mg/dL at baseline to 5.1 mg/dL
at the end of the 26-week treatment period in the efficacy analysis
set (n=131), and a clinically meaningful decrease in mean
serum phosphorus in the tenapanor-treated patients from 7.4 mg/dL
at baseline to 5.9 mg/dL at week 26 in the intent-to treat analysis
set (n=248). Additionally, in the efficacy analysis set (n=131),
the difference in estimated mean change in serum phosphorus level
between tenapanor and placebo from the beginning to the end of the
randomized withdrawal period was −1.4 mg/dl (P<0.0001).
Furthermore, there were median relative reductions from baseline of
23% for iFGF23 and 14% for cFGF23 at the end of the randomized
26-week treatment period for participants randomized to
tenapanor. Diarrhea was the only drug related AE reported for
more than 5% of patients and resulted in drug discontinuation in
16% of patients.
About Tenapanor
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 30mg tablet
BID dosing regimen. The most common side effect with tenapanor in
clinical trials was diarrhea.
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 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 the potential for
tenapanor to advance the management of phosphorus in 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, uncertainties associated with the regulatory approval
process and uncertainties associated with the drug development
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 13,
2021, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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