Ardelyx Presents Positive Data Further Supporting Efficacy and Safety of XPHOZAH® (tenapanor) at National Kidney Foundation 2023 Spring Clinical Meetings
12 April 2023 - 10:05PM
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 multiple presentations covering additional positive
clinical observations of XPHOZAH at the National Kidney Foundation
(NKF) 2023 Spring Clinical Meetings, which is taking place in
Austin, TX from April 11-15, 2023. Ardelyx has completed three
successful Phase 3 pivotal clinical trials, and two additional
Phase 4 open-label clinical trials (OPTIMIZE and NORMALIZE) for
XPHOZAH, an investigational, novel phosphate absorption inhibitor
studied in adult patients with chronic kidney disease (CKD) on
maintenance dialysis seeking to control their serum phosphate.
XPHOZAH was discovered and developed by Ardelyx.
“The results of these three post hoc analyses reinforce our
understanding of the potential value that XPHOZAH offers by
expanding the treatment armamentarium for health care providers and
their patients with chronic kidney disease on maintenance dialysis
who suffer from hyperphosphatemia,” said Laura Williams, M.D.,
M.P.H., chief medical officer of Ardelyx. “These studies
demonstrated that patients are seeing measurable benefit from
XPHOZAH across different endpoints, and that the novel mechanism of
action provides a much-needed additional treatment option for
patients.”
Posters presented at NKF Spring Clinical
Meeting
- Poster # 252
titled “Post Hoc Analyses of Serum
Phosphate Changes with Tenapanor in Black/African American and
White Patients on Maintenance Dialysis”
reported data on serum phosphate (sP) changes in Black/African
American and White patients who were treated with XPHOZAH. This
analysis included data from all three Phase 3 registration studies:
a 12-week monotherapy study (BLOCK), a 52-week monotherapy study
(PHREEDOM) and a four-week combination study (AMPLIFY). For all
trials, the first available sP measurement was after one week of
treatment, per protocol. Across all three Phase 3 studies, which
included a total of 457 patients (53% Black/African American and
47% White), XPHOZAH consistently lowered sP in patients with CKD on
maintenance dialysis, regardless of race, and the safety profile
was consistent and acceptable across all three studies, with
diarrhea being the most common adverse event.
- Poster # 251
titled “An In-Depth Analysis of Serum
Phosphate Changes in Patients with CKD on Dialysis: Results from
the PHREEDOM Study” reported results from
post hoc analyses of sP concentrations in patients with CKD on
maintenance dialysis who were treated with XPHOZAH or sevelamer
from the 52-week, Phase 3 monotherapy study (PHREEDOM). In the
current analysis, sP concentrations were analyzed in
tenapanor-treated and sevelamer-treated patients who had at least a
1.2 mg/dL reduction from baseline at week 26 (defined as sP
responders) and for all patients who completed treatment for 52
weeks. This analysis demonstrated these patients had comparable sP
reductions when treated with XPHOZAH or sevelamer for
hyperphosphatemia. Tenapanor treatment had the added benefit of
twice daily dosing and a lower pill burden. Diarrhea was the most
common adverse event reported by patients treated with XPHOZAH,
with a higher incidence rate in these patients. Prior sevelamer use
by over 60% of the sevelamer-treated patients may, in part, explain
the lower overall rate of adverse events for these patients
compared to the rates reported in the sevelamer prescribing
information. Overall, this post hoc analysis of the PHREEDOM study
demonstrates the potential value of XPHOZAH as an additional
treatment option for hyperphosphatemia in patients with CKD
receiving maintenance dialysis.
- Poster # 193
titled “Evaluation of Changes in Serum
FGF23 With Tenapanor Treatment in Patients with Chronic Kidney
Disease on Dialysis” reported data on the
effect of XPHOZAH on elevated intact fibroblast growth factor 23
(iFGF23) in patients with CKD on maintenance dialysis from the
NORMALIZE and OPTIMIZE studies, an open-label 18-month extension
study and a 26-week open label study, respectively. For this
analysis, changes in iFGF23 from baseline to the end of NORMALIZE
(up to 18 months) and baseline to the end of OPTIMIZE part A
(initial 10 weeks of treatment) were evaluated for the full
analysis set (FAS) of each study. Among all patients in NORMALIZE
from the FAS, median iFGF23 reduction (percent reduction) was 384.0
pg/mL (42.2%) from baseline to the end of the study. In OPTIMIZE,
at the end of part A, the median iFGF23 reduction (percent
reduction) was 739.2 pg/mL (20%) from baseline in the FAS. While
there was variability in the degree of reduction, many patients who
responded to XPHOZAH as core therapy, with a reduction in sP
levels, also experienced reduction in iFGF23 levels. Results from
the NORMALIZE and OPTIMIZE trials demonstrated that XPHOZAH is
effective at reducing iFGF23 in patients with CKD on maintenance
dialysis, which is consistent with findings from the PHREEDOM
study. Results from both NORMALIZE and OPTIMIZE trials support the
long-term safety of XPHOZAH. Adverse events were similar to those
of previous studies, with diarrhea being the most common adverse
event.
About PHREEDOM PHREEDOM is a one-year
Phase 3 study with a 26-week open-label treatment period, a 12-week
double-blind, placebo-controlled randomized withdrawal period, and
a 14-week open-label safety extension period. The study randomized
a total of 564 patients with CKD on maintenance dialysis who had a
serum phosphate between 6.0 mg/dL and 10.0 mg/dL and had an
increase in serum phosphate of at least 1.5 mg/dL after an up to
3-week phosphate binder wash-out period. The primary efficacy
endpoint of the study was the difference in change in serum
phosphate between the XPHOZAH-treated patients and placebo-treated
patients in the efficacy analysis set from the end of the 26-week
treatment period to the endpoint visit of the 12-week randomized
withdrawal period. The efficacy analysis set (n=131) included
patients who completed the 26-week treatment period and achieved a
1.2 mg/dL decrease in serum phosphate in the same period. This
study also included an active safety comparator (sevelamer), which
had no prespecified efficacy comparisons.
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 AMPLIFY AMPLIFY, a double-blind,
placebo-controlled, randomized study, enrolled a total of 236
patients with CKD on maintenance dialysis, who, despite phosphate
binder therapy, had a serum phosphate level greater than or equal
to 5.5 mg/dL and less than or equal to 10.0 mg/dL at screening.
After a run-in of two to four weeks, patients were randomized 1:1
to receive tenapanor or placebo twice daily while continuing their
established phosphate binder regimen. Baseline serum phosphate at
randomization was at a mean level of 6.8 mg/dL. Tenapanor was
initiated at a starting dose of 30 mg twice daily with tenapanor
dose adjustments allowed based on serum phosphate level and
gastrointestinal tolerability. The primary endpoint of the study
was the comparison of the change from baseline in serum phosphate
levels at week four between the tenapanor and binder arms. The key
secondary endpoints included a comparison of the proportion of
patients achieving a serum phosphate level below 5.5 mg/dL at week
four and relative change from baseline in fibroblast growth factor
23 (FGF23) levels between the tenapanor and binder arms at week
four.
About OPTIMIZE OPTIMIZE is a randomized,
open label study, which included 330 patients with CKD on
maintenance dialysis with hyperphosphatemia. The study was designed
to evaluate different methods of initiating XPHOZAH to optimize
phosphate 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 CKD on
maintenance dialysis, alone or in combination with phosphate
binders, to achieve target serum phosphate (sP) levels less than or
equal to 5.5 mg/dL. The study randomized patients on a stable dose
of phosphate binder treatment with sP greater 5.5 and less than or
equal to 10.0 mg/dL in a 1:1 ratio to two different treatment
cohorts, as well as patients who were phosphate binder naïve with
sP greater than 4.5 and less than or equal to 10.0 mg/dL in a third
cohort.
About XPHOZAH® (tenapanor) XPHOZAH,
discovered and developed by Ardelyx, is a first-in-class, phosphate
absorption inhibitor that has a novel 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 twice daily 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
phosphate in the blood that is estimated to affect the vast
majority of the 550,000 patients in the United States with chronic
kidney disease (CKD) on maintenance dialysis. The kidney is the
organ responsible for regulating phosphate, but when kidney
function is significantly impaired, 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).
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 for the control of serum
phosphate in adult patients with chronic kidney disease (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. For more information,
please visit https://ardelyx.com/ and connect with us on Twitter,
LinkedIn and Facebook.
Forward Looking StatementsTo 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 role that
tenapanor can play in offering new treatment options for patients
with hyperphosphatemia. 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 process for drug development, regulatory
approval and commercialization. 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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 2, 2023,
and its future current and periodic reports to be filed with the
Securities and Exchange Commission.
Investor and Media Contacts:
Caitlin Lowie clowie@ardelyx.com
Kimia Keshtbod kkeshtbod@ardelyx.com
Ardelyx (NASDAQ:ARDX)
Historical Stock Chart
Von Jul 2024 bis Aug 2024
Ardelyx (NASDAQ:ARDX)
Historical Stock Chart
Von Aug 2023 bis Aug 2024