FREMONT, Calif. and
WALTHAM, Mass., Nov. 5, 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 multiple
presentations covering additional positive clinical observations
with tenapanor at the American Society of Nephrology Kidney Week
2021 (ASN Kidney Week), which is taking place virtually
November 4 - November 7, 2021.
Ardelyx has completed three successful Phase 3 pivotal trials, and
an additional clinical trial (OPTIMIZE) for tenapanor, an
investigational, first-in-class phosphate absorption inhibitor for
the control of serum phosphorus in adult patients with chronic
kidney disease (CKD) on dialysis. Tenapanor was discovered and
developed by Ardelyx.
![Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx) Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx)](https://mma.prnewswire.com/media/1309911/Ardelyx_Logo.jpg)
"These data provide additional perspective on the potential
benefits of tenapanor and further support its utility in the
management of serum phosphorus," said Laura
Williams, M.D., MPH, chief medical officer for Ardelyx. "We
continue to pursue approval of this first-in-class, novel therapy
which we believe represents an important innovation for the
nephrology community."
"As a person living with kidney disease who has struggled with
managing phosphorus, it gives me great hope to see the patient
perspective and patient priorities being incorporated into clinical
studies," said Derek Forfang, chair,
NKF Kidney Patient Advocacy Committee and co-chair, Forum of ESRD
Networks' Kidney Patient Advisory Council. "The OPTIMIZE results
suggest that tenapanor could have an enormous positive impact on
the health and quality of life of many patients on dialysis through
its novel mechanism that blocks, not binds, phosphorus. Tenapanor
has the potential to help more patients achieve target phosphorus
levels and reduce the treatment burden associated with currently
available hyperphosphatemia therapies. The incorporation of the
patient voice into the clinical trial design and evaluation of
tenapanor is a huge step forward for patients."
Pablo E. Pergola, M.D., Ph.D.,
director, Clinical Advancement Center, Renal Associates PA,
San Antonio, Texas, added, "These
data for tenapanor reported at ASN reveal new important
observations, including its efficacy in both peritoneal dialysis
and hemodialysis, its ability to lower PTH and FGF23 levels, and
its lowering of serum phosphorus without affecting other
electrolytes. In addition, the new data reported from the OPTIMIZE
trial provides a first glimpse into the real-world use of
tenapanor, showing its ability not only to help more patients
achieve target phosphorus levels, but also its ability to improve
the patient experience regarding the management of
hyperphosphatemia."
New clinical observations presented at ASN:
- ePoster # PO1733 titled "Patient-Reported Experience with
Tenapanor in the OPTIMIZE Trial" presents the first
data generated from the randomized, open-label OPTIMIZE trial
designed to evaluate ways to integrate tenapanor into clinical
practice to optimize phosphorus management in patients with CKD on
dialysis. Patients who were being treated with phosphate binders
were equally divided into two groups: one (n=123) that was switched
from binders to tenapanor (straight switch arm), and another
(n=123) that reduced their binder dose by 50% upon starting
tenapanor 30 mg twice daily (50% binder dose reduction arm). 82.1%
of patients in the straight switch arm and 85.4% of patients in the
50% binder dose reduction arm reported an improvement in their
overall experience managing phosphorus with tenapanor compared to
their previous experience managing phosphorus, primarily due to an
improved medication regimen. Approximately 30% of patients
reported improved frequency of bowel movements as the top reason
for the improved treatment experience with tenapanor.
- ePoster # PO0544 titled "Impact of Tenapanor in
Peritoneal Dialysis," based on a post-hoc analysis
from the PHREEDOM study, demonstrates similar safety and efficacy
in serum phosphorus reduction among patients on peritoneal dialysis
(PD) (n=42) and patients on hemodialysis (HD) (n=365) treated with
tenapanor. The mean change from baseline to week 26 was -1.70 mg/dL
in the PD group vs. -1.33 in the HD group, and the safety profile
of tenapanor was also similar between the groups.
- ePoster # TH-OR18 titled "Tenapanor Controls Serum
Phosphorus and Reduces PTH and FGF-23 in Patients on Dialysis with
Severe Secondary Hyperparathyroidism" evaluates tenapanor's
effect on serum phosphorus (sP), parathyroid hormone (PTH) and
fibroblast growth factor 23 (FGF23) levels in patients with severe
secondary hyperparathyroidism (iPTH>600 pg/mL). In this post-hoc
analysis from PHREEDOM, patients treated with tenapanor had ~22%,
34% and 41% reductions in sP, PTH and FGF23, respectively. PTH is a
common co-morbidity and elevated levels of FGF23 have been linked
to greater risks of LVH (left ventricular hypertrophy) and
mortality in patients with CKD.
- ePoster # PO1732 titled "Long-Term Safety of Tenapanor
for the Control of Serum Phosphorus in Patients with CKD on
Dialysis: Serum Electrolytes and Albumin" evaluates the
effects of tenapanor on serum electrolytes and albumin, based on a
post-hoc analysis from the three tenapanor pivotal trials, all of
which met their primary and key secondary endpoints, and shows that
tenapanor decreases serum phosphorus selectively by inhibiting
paracellular absorption of phosphate without affecting other serum
electrolytes (sodium, bicarbonate, chloride, potassium, calcium,
magnesium) or serum albumin.
About OPTIMIZE
OPTIMIZE is 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 tenapanor to optimize phosphorus
management in both binder-naïve and binder-treated patients. The
objective was to evaluate the ability of tenapanor, 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. Patients with s-P >5.5 and ≤10.0 mg/dL during stable
phosphate binder treatment were randomized in a 1:1 ratio to two
different treatment cohorts: Cohort 1, a straight switch approach
where current phosphate binder treatment was discontinued and
patients were switched to tenapanor 30 mg twice daily (BID) or
Cohort 2, where current phosphate binder dose was reduced by at
least 50% and tenapanor therapy was initiated at 30 mg BID. After
week 2, investigators could adjust phosphate binder dose to achieve
a phosphorus level of ≤5.5 mg/dL with tenapanor as the core therapy
and binders as adjunctive. A third cohort comprised of phosphate
binder naïve patients with s-P >4.5 and ≤10.0 mg/dL (Cohort 3)
were enrolled and initiated on tenapanor 30 mg BID.
About Tenapanor
Tenapanor, discovered and developed by Ardelyx, is a
first-in-class phosphate absorption inhibitor (PAI) that 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/ardelyx-reports-additional-positive-data-supporting-clinical-utility-of-tenapanor-at-asns-kidney-week-2021-301417479.html
SOURCE Ardelyx