Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023
03 Novembre 2023 - 1:00PM
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 shared positive data on the use of XPHOZAH® (tenapanor) in
poster presentations at the American Society of Nephrology (ASN)
Kidney Week 2023 meeting, currently being held in Philadelphia,
Pennsylvania, and will showcase XPHOZAH in an Exhibitor Spotlight
event. Ardelyx’s presence at Kidney Week 2023 will honor the memory
of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and
a passionate advocate for patients with kidney disease.
XPHOZAH, the first and only phosphate absorption inhibitor, was
approved by the U.S. Food and Drug Administration on October 17,
2023 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 that blocks phosphate absorption at the primary
pathway and is administered as a single tablet taken twice
daily.
“We are thrilled to share compelling data highlighting why
XPHOZAH, with its differentiated blocking mechanism, may benefit
patients who have hyperphosphatemia despite ongoing treatments with
currently available therapies,” said Laura Williams, M.D., M.P.H.,
Chief Medical Officer at Ardelyx. “The data being presented at ASN
Kidney Week 2023 highlight why we are enthusiastic to bring this
medication to patients who struggle to achieve target treatment
goals and to their healthcare providers who are in need of a new
treatment option.”
- The first poster, titled Optimal Initiation of
Tenapanor Treatment Analyzed by Baseline Phosphate Binder Dose: A
Sub-analysis of the OPTIMIZE Study, looked at serum
phosphate (sP) control across two cohorts of patients by phosphate
lowering pill burden. In OPTIMIZE, Cohort 1 added tenapanor 30 mg
twice a day and stopped using phosphate binders, while Cohort 2
added tenapanor 30 mg twice a day and reduced their phosphate
binder dose by ≥50%. The OPTIMIZE study showed that both cohorts
experienced improved sP control and improved patient reported
quality of life, as well as a reduction in pill burden. This
analysis suggests that patients on high phosphate binder dosage
(more than six pills per day) may have better early sP control by
initiating tenapanor with a 50% reduction in phosphate binder
dosage, while patients on lower dosage of phosphate binders had
similar early sP control regardless of the tenapanor initiation
strategy.
- In a poster titled Patient Education Improves Adherence
to Tenapanor Treatment in OPTIMIZE Study, researchers
looked at the effect of patient education on adherence, using data
from the OPTIMIZE study compared to data from two phase 3 clinical
studies of tenapanor, BLOCK and PHREEDOM. In the OPTIMIZE study,
patients were provided with a patient brochure including
information on how to take tenapanor, what they might experience
while on the medication, which medications should be discontinued
and ways to mitigate potential onset of loose stools or diarrhea.
The study found that this educational information improved
adherence, and may have specifically reduced medication
discontinuation due to changes in bowel habits.
- The third poster, Safety Analysis of Tenapanor
Monotherapy vs Sevelamer Carbonate in Patients on Maintenance
Dialysis with Hyperphosphatemia, reviewed patient data
from the PHREEDOM study that evaluated tenapanor for the treatment
of hyperphosphatemia in patients with CKD on maintenance dialysis.
It aimed to compare adverse events between patients who received
tenapanor 30 mg twice a day and patients in the safety population
who received sevelamer per standard of care during a 26-week
randomized treatment period. The study showed that a lower
proportion of patients treated with tenapanor versus sevelamer
experienced a serious adverse event (SAE) while the exposure
adjusted rates were similar. This analysis also showed that the
incidence of adverse events leading to hospitalization (also
characterized as an SAE) was lower in the tenapanor arm than the
sevelamer arm while the exposure adjusted rates were similar. The
analysis concluded that tenapanor has an acceptable safety and
tolerability profile in patients with CKD on maintenance
dialysis.
- The final Ardelyx poster to be shared at ASN, Tenapanor
in Combination with Phosphate Binders Improves Short and Long-Term
Control of Serum Phosphate (sP) in Patients on Dialysis with
Hyperphosphatemia (FR-PO318), will be available from
10:00am to 12:00pm ET on Friday, November 3, 2023.
These poster presentations are publicly available and can be
accessed on demand here.
Additionally, Ardelyx is hosting an XPHOZAH Exhibitor Spotlight
at ASN Kidney Week 2003. The session, titled A New
Paradigm: Rethinking Hyperphosphatemia Management will be
held at 11:00 AM on Friday, November 3, 2023 in Theater 2 in
Exhibit Hall B of the Pennsylvania Convention Center. The Spotlight
will be presented by Arnold Silva, MD, PhD. Director of Home and
Peritoneal Dialysis Programs, Boise Kidney & Hypertension
Institute, and by David Spiegel, MD, Vice President of Nephrology
at Ardelyx.
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 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
INFORMATIONCONTRAINDICATIONSXPHOZAH is
contraindicated in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal
obstruction
WARNINGS AND
PRECAUTIONSDiarrheaPatients may
experience severe diarrhea. Treatment with XPHOZAH should be
discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONSDiarrhea, 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.
INDICATIONXPHOZAH (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 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 has two commercial products approved in the United States,
IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) as well as
early-stage pipeline candidates. Ardelyx has agreements for the
development and commercialization of tenapanor outside of the U.S.
Kyowa Kirin has received approval for 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
Kimia Keshtbod kkeshtbod@ardelyx.com
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