Ardelyx to Present Additional Data Supporting First-In-Class XPHOZAH® (tenapanor) for Adults with Chronic Kidney Disease on Dialysis at the National Kidney Foundation 2024 Spring Clinical Meetings
01 Maggio 2024 - 2:00PM
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 announced that additional data supporting XPHOZAH®
(tenapanor) will be presented at the National Kidney Foundation
(NKF) 2024 Spring Clinical Meetings, to be held May 14-18, 2024, in
Long Beach, California. 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 that blocks phosphate absorption at
the primary pathway and is administered as a single tablet taken
twice daily.
Title: Tenapanor Treatment Added to Phosphate Binders
Improved Long-Term Serum Phosphate (P) Control as Measured by
Reduction in Average Daily P Area Under the CurveAuthors:
Kevin J. Martin, David M. Spiegel, Yang Yang, David Rosenbaum,
Susan Edelstein, Laura WilliamsPoster Number: 239Date/Time: May 15,
2024, from 5:30 PM to 7:00 PM PDT (UTC –7)
Title: Treatment Response to Tenapanor Categorized by
Age and Comorbidities: A Post Hoc Analysis of the PHREEDOM
StudyAuthors: Daniel Weiner, David M. Spiegel, Yang Yang,
David Rosenbaum, Susan EdelsteinPoster Number: 243Date/Time: May
15, 2024, from 5:30 PM to 7:00 PM PDT (UTC –7)
Title: Patient Perception of Phosphate-Lowering
Treatment Regimen Improves Adherence to TherapyAuthors:
Amy Mosman, Susan Edelstein, David M. Spiegel, Suling Zhao, David
RosenbaumPoster Number: 240Date/Time: May 15, 2024, from 5:30 PM to
7:00 PM PDT (UTC –7)
In addition to the poster presentations during NKF Spring
Clinical Meetings, Ardelyx is sponsoring an Exhibitor Showcase
titled: “A New Paradigm: Rethinking Hyperphosphatemia
Management,” on May 17, 2024, from 8:30-9:05 AM PDT, where
David M. Spiegel, MD and Lisa Gutekunst MSEd, RD, CSR, CDN, FNKF,
will discuss first-in-class PAI, XPHOZAH. The presentation will
review the XPHOZAH mechanism of action, efficacy and safety data
from the Phase 3 clinical trial program and will include a
discussion about the clinical application of XPHOZAH as add-on
therapy for the many dialysis patients on a phosphate binder with
serum phosphorus levels above guideline-established targets.
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 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) as well as early-stage
pipeline candidates. 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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