XPHOZAH monotherapy lowers serum phosphorus
with early responders maintaining response with continued
treatment
XPHOZAH monotherapy meaningfully reduced serum
phosphorus in patients with severe hyperphosphatemia
XPHOZAH in combination with phosphate binders
reduced patients' interdialytic weight gain compared to binders
alone
WALTHAM,
Mass., Nov. 3, 2022 /PRNewswire/ -- Ardelyx,
Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a
mission to discover, develop and commercialize innovative
first-in-class medicines that meet significant unmet medical needs,
today announced that new analyses of data from its three Phase 3
trials supporting the clinical utility of XPHOZAH (tenapanor) will
be presented at the American Society of Nephrology (ASN) Kidney
Week 2022, taking place in Orlando,
Florida from November 3-6,
2022. XPHOZAH is an investigational first-in-class phosphate
absorption inhibitor (PAI) for the control of serum phosphorus in
adult patients with chronic kidney disease (CKD) on dialysis.
"These data continue to support the benefit that novel-mechanism
XPHOZAH could have for patients on dialysis with
hyperphosphatemia," said David
Rosenbaum, Ph.D., chief development officer for Ardelyx.
"Notably, early response to XPHOZAH was found to be predictive of
continued response throughout the treatment period. This
information could help guide treatment decisions that maximize the
potential therapeutic benefit of XPHOZAH for these patients. With
over 1,100 patients treated with XPHOZAH in clinical studies in the
U.S. as well as clinical data generated by our partner Kyowa Kirin
in Japan, we believe the impact
that this first-in-class treatment could have for CKD patients on
dialysis is clear."
New Clinical Analyses Being Presented by Ardelyx:
Poster # PO163 titled "The Predictive Value of Early Response to
Tenapanor for the Treatment of Hyperphosphatemia in Patients
Receiving Maintenance Dialysis" was based on a post hoc analysis of
the Phase 3 PHREEDOM study evaluating if an early reduction in
serum phosphorous (sP) following treatment with XPHOZAH would
predict continued control of sP during subsequent treatment. Among
patients who responded to XPHOZAH (>1.2 mg/dL decrease in
sP from baseline) within the first month and remained on treatment,
approximately 80% continued to have at least a 1.2 mg/dL decrease
in sP from baseline during weeks 17-26 of the treatment period.
Poster # PO162 titled "Reduction of Serum Phosphorus (sP) with
Tenapanor in Patients with Chronic Kidney Disease (CKD) on Dialysis
with Severe Hyperphosphatemia" presented post hoc analyses of the
two Phase 3 monotherapy studies BLOCK and PHREEDOM to determine the
effect of XPHOZAH monotherapy on dialysis patients with severe
hyperphosphatemia, which was defined as having a baseline sP ≥7.5
mg/dL. Patients with severe hyperphosphatemia from the BLOCK and
PHREEDOM studies had clinically meaningful mean sP reductions of
1.78 and 1.94 mg/dL, respectively, from baseline to the end of the
randomized treatment periods or last assessment.
Poster # PO400 titled "Tenapanor Plus Phosphate Binder Reduces
Interdialytic Weight Gain (IDWG) in Patients with Chronic Kidney
Disease (CKD) on Hemodialysis (HD): Post Hoc Analysis of the
AMPLIFY Study" examined pre-HD weights in patients to assess
whether treatment with XPHOZAH in combination with phosphate
binders decreased IDWG, which is associated with adverse patient
outcomes, as compared with patients treated with phosphate binders
alone. At week 4, the mean pre-HD weight decreased in patients
whose treatment included XPHOZAH, while it increased in patients
who received phosphate binders alone.
Ardelyx Exhibitor Spotlight Presentation:
In addition to the poster presentations highlighting tenapanor
clinical data, Ardelyx is sponsoring an Exhibitor Spotlight titled:
"The Phosphorus Management Puzzle and Need for New Pieces: The
Patient and Physician Perspective", on Saturday November 5, 2022, from 12:30-1:15pm ET. During this Exhibitor Spotlight,
Geoffrey Block, MD, associate chief
medical officer and senior vice president of clinical research and
medical affairs at U.S. Renal Care, and Dawn P. Edwards, patient ambassador, co-chair,
national forum of ESRD networks kidney patient advisory council,
will review the consequences of hyperphosphatemia, the current
understanding of phosphate absorption, and the importance of
managing hyperphosphatemia, including current management practices
and inherent challenges. Dr. Block is also a member of Ardelyx's
board of directors.
Clinical Data Being Presented by Kyowa Kirin Co., Ltd. (Kyowa
Kirin):
Kyowa Kirin, the company's collaboration partner for tenapanor
in Japan, is presenting data from
two Phase 3 studies evaluating the efficacy and safety of tenapanor
in hemodialysis patients in Japan.
The results of the studies are summarized in Kyowa Kirin's press
release dated October 20, 2022.
- Poster # PO160 titled "Efficacy and Safety of Tenapanor on
Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a
Randomized Phase 3 Trial"
- Poster # PO161 titled "Efficacy and Safety of Tenapanor Added
to Phosphate Binders for Hemodialysis Patients Who Have Poorly
Controlled Hyperphosphatemia on Existing Phosphate Binders: Results
of a Randomized Phase 3 Trial"
About XPHOZAH (tenapanor) for
Hyperphosphatemia
XPHOZAH (tenapanor), discovered and developed by Ardelyx,
is an investigational first-in-class phosphate absorption inhibitor
(PAI). With its unique blocking mechanism of action, XPHOZAH 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 XPHOZAH 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 more than 745,000 dialysis patients in major
developed countries. 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 (2.5-4.5
mg/dL).
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and
commercialize innovative first-in-class medicines that meet
significant unmet medical needs. Ardelyx's first approved product,
IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing
XPHOZAH® (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 has a
Phase 2 potassium lowering compound, RDX013, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. 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
therapeutic benefit that tenapanor could have, if approved, in
controlling hyperphosphatemia in CKD 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 clinical development and regulatory processes. 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 4,
2022, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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