Ardelyx Announces Publication of Two Plain Language Summaries from XPHOZAH® (tenapanor) Clinical Trials in Current Medical Research and Opinion
July 31 2024 - 8:02AM
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 the publication of plain language summaries of
results from two clinical trials on XPHOZAH® (tenapanor), NORMALIZE
and OPTIMIZE, in Current Medical Research and Opinion. The plain
language summaries were developed by the authors to help adult
patients with chronic kidney disease receiving dialysis, and their
family members and caregivers, better understand some of the safety
and efficacy data related to XPHOZAH.
XPHOZAH, the first and only phosphate absorption inhibitor
(PAI), is approved by the U.S. Food and Drug Administration to
reduce serum phosphorus in adults with chronic kidney disease (CKD)
on dialysis as add-on therapy in patients who have an inadequate
response to phosphate binders or who are intolerant of any dose of
phosphate binder therapy. XPHOZAH offers a different mechanism of
action, blocking phosphate absorption at the primary pathway and is
administered as a single tablet taken twice daily.
“We are proud to provide the clinical trials results for both
the NORMALIZE and OPTIMIZE studies to patients in a format that is
both useful and relevant to their needs. Plain language summaries,
like these, help patients and their caregivers better understand
their options and the potential impact XPHOZAH may have on lowering
their serum phosphorus levels,” said Laura Williams, MD MPH, chief
medical officer of Ardelyx. “Our entire Ardelyx team would like to
express our gratitude to the patients who participated in these
clinical trials, whose contributions are now helping other patients
better understand the complications associated with elevated serum
phosphorus and this new treatment option. We would also like to
recognize the study authors who worked with our partners in the
patient advocacy community to ensure that these plain language
summaries could be made available to our patients.”
Current Medical Research and Opinion is an international journal
that publishes research focused on new and existing drugs and
therapies, best practices in patient care, developments in
diagnostic medicine and medical technology, and innovations in
medical and scientific publishing. The first article, titled
“Tenapanor improves long-term control of high phosphate
concentrations in the blood in patients receiving maintenance
dialysis: a plain language summary of the NORMALIZE study,”
describes results from the NORMALIZE study, is available online and
can be found here. The second article, titled “Effectiveness of
tenapanor for treating hyperphosphatemia in patients receiving
dialysis: a plain language summary of the OPTIMIZE study” provides
a review of the OPTIMIZE study, is available online and can be
found here. Both articles are summaries of data originally
published in Kidney360.
About XPHOZAH® (tenapanor)XPHOZAH, discovered
and developed by Ardelyx, is a first-in-class, phosphate absorption
inhibitor with a differentiated mechanism of action that acts
locally in the gut to inhibit the sodium hydrogen exchanger 3
(NHE3), thereby reducing phosphate absorption through the
paracellular pathway, the primary pathway of phosphate absorption.
XPHOZAH is a single tablet, taken twice daily. Diarrhea was the
most common side effect experienced by patients taking XPHOZAH in
clinical trials. Please see additional full Prescribing
Information.
About NORMALIZE Patients completing the Phase 3
PHREEDOM trial from both the XPHOZAH arm and the sevelamer safety
control arm had the option to participate in NORMALIZE, an
open-label 18-month extension study. Patients entering the study
from the XPHOZAH arm with serum phosphate levels in the normal
range were followed with no medication changes. Patients entering
the study from the XPHOZAH arm with serum phosphate greater than
4.5 mg/dL had sevelamer tablets added incrementally to achieve
normal serum phosphate levels. Patients entering the study from the
sevelamer safety control arm had XPHOZAH tablets added to their
treatment regimen while reducing sevelamer tablets based on their
serum phosphate value to achieve normal serum phosphate levels. The
primary objective of the study was to evaluate the ability of
XPHOZAH alone or in combination with sevelamer to achieve serum
phosphate levels within the normal range (2.5 to 4.5 mg/dL) in
patients with CKD on maintenance dialysis whose serum phosphate
levels were greater than 6.0 mg/dL at baseline.
About OPTIMIZEOPTIMIZE was a randomized, open
label study, which included 330 patients with chronic kidney
disease (CKD) on dialysis with hyperphosphatemia. The study was
designed to evaluate different methods of initiating XPHOZAH to
optimize phosphorus management in both binder-naïve and
binder-treated patients. The objective was to evaluate the ability
of XPHOZAH, with its novel blocking mechanism, administered as core
therapy for the treatment of hyperphosphatemia in adult patients
with chronic kidney disease (CKD) on dialysis, alone or in
combination with phosphate binders, to achieve target serum
phosphorus (s-P) levels ≤5.5 mg/dL. The study enrolled patients
with s-P >5.5 and ≤10.0 mg/dL during stable phosphate binder
treatment which were randomized in a 1:1 ratio to two different
treatment cohorts, as well as patients who were phosphate binder
naïve with s-P >4.5 and ≤10.0 mg/dL in a third cohort.
About HyperphosphatemiaHyperphosphatemia is a
serious condition, defined as elevated levels of phosphate in the
blood, which affects the vast majority of the 550,000 patients in
the United States with chronic kidney disease (CKD) on maintenance
dialysis. The kidneys are responsible for eliminating excess
phosphate and as kidney function declines, phosphate is not
adequately eliminated from the body. As a result, hyperphosphatemia
is a nearly universal condition among people with CKD on
maintenance dialysis, with internationally recognized KDIGO
treatment guidelines that recommend lowering elevated phosphate
levels toward the normal range (2.5-4.5mg/dL).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSXPHOZAH is contraindicated
in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal
obstruction
WARNINGS AND
PRECAUTIONSDiarrhea Patients may
experience severe diarrhea. Treatment with XPHOZAH should be
discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONS Diarrhea, which
occurred in 43-53% of patients, was the only adverse reaction
reported in at least 5% of XPHOZAH-treated patients with CKD on
dialysis across trials. The majority of diarrhea events in the
XPHOZAH-treated patients were reported to be mild-to-moderate in
severity and resolved over time, or with dose reduction. Diarrhea
was typically reported soon after initiation but could occur at any
time during treatment with XPHOZAH. Severe diarrhea was reported in
5% of XPHOZAH-treated patients in these trials.
INDICATION XPHOZAH (tenapanor), 30 mg BID, is
indicated to reduce serum phosphorus in adults with chronic kidney
disease (CKD) on dialysis as add-on therapy in patients who have an
inadequate response to phosphate binders or who are intolerant of
any dose of phosphate binder therapy.
For additional safety information, please see full Prescribing
Information.
About ArdelyxArdelyx was founded with a mission
to discover, develop and commercialize innovative, first-in-class
medicines that meet significant unmet medical needs. Ardelyx has
two commercial products approved in the United States, IBSRELA®
(tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for
the development and commercialization of tenapanor outside of the
U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for
hyperphosphatemia in Japan. A New Drug Application for tenapanor
for hyperphosphatemia has been submitted in China with Fosun
Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For
more information, please visit https://ardelyx.com/ and connect
with us on X (formerly known as Twitter), LinkedIn and
Facebook.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
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