FREMONT, Calif. and
TOKYO, Oct.
22, 2020 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq:
ARDX), a biopharmaceutical company developing targeted,
first-in-class medicines to improve the lives of patients with
kidney and cardiovascular diseases, and Kyowa Kirin Co.,
Ltd. (Kyowa Kirin, TSE: 4151) today highlighted new clinical
data presented within five posters at Kidney Week 2020, this year's
virtual Annual Meeting of the American Society of Nephrology (ASN)
that is now underway.
Of the posters presented today, three highlight tenapanor
clinical data from Ardelyx's Phase 3 trials in the U.S., including
the BLOCK, AMPLIFY, and PHREEDOM studies, while two present results
from the Phase 2 studies evaluating the efficacy and safety of
tenapanor in Japanese patients on hemodialysis conducted by Kyowa
Kirin, to whom Ardelyx has licensed exclusive rights to develop and
commercialize tenapanor in Japan
for the treatment of cardiorenal diseases. In Japan, Kyowa Kirin has conducted three Phase 2
trials of tenapanor as KHK7791. Tenapanor, which was discovered and
developed by Ardelyx, is a first-in-class therapy currently under
review for potential marketing approval by the U.S. Food and Drug
Administration (FDA) for the control of serum phosphorus in adult
patients with chronic kidney disease (CKD) on dialysis.
Kevin Martin, MD, Professor of
Internal Medicine and Director, Division of Nephrology,
Saint Louis University commented:
"Despite the serious cardiovascular consequences of elevated
phosphorus levels, and the development of a variety of phosphate
binders, we have made little progress in achieving sustained
control of hyperphosphatemia over the past 30 years. Recent
advances in our mechanistic understanding of phosphate absorption
have led to a whole new way of thinking about how to manage
hyperphosphatemia. With its novel mechanism of action targeting
paracellular phosphate transport and comprehensive clinical data
continuing to support its efficacy and safety, I believe tenapanor,
if approved, has the potential to truly transform the management of
hyperphosphatemia."
Ardelyx Poster Presentations:
- ePoster #PO0384, entitled "Long-term Safety and Efficacy
of Tenapanor for the Control of Serum Phosphorus in Patients with
CKD on Dialysis," further summarizes data from PHREEDOM, a
long-term Phase 3 U.S. study evaluating the safety and efficacy of
tenapanor for the control of serum phosphorus in patients with CKD
on dialysis. New details presented demonstrate that, within the
efficacy analysis set, treatment with tenapanor resulted in
sustained reductions in serum phosphorus concentrations, decreasing
mean serum phosphorus from 7.7 mg/dL at baseline to 5.1 mg/dL at
the end of the randomized treatment period.
- ePoster #PO0374, entitled "Efficacy of Tenapanor for the
Control of Serum Phosphorus in Patients with CKD on Dialysis: Novel
Mechanism of Action Allows for Both Monotherapy and Dual Mechanism
Approach," presents clinical data from two Phase 3 clinical
trials, demonstrating that tenapanor reduces serum phosphorus when
used as monotherapy in hyperphosphatemia patients with CKD on
dialysis (BLOCK trial) and reduces serum phosphorus levels in
patients with difficult-to-control hyperphosphatemia when used with
phosphate binders as part of a dual-mechanism approach (AMPLIFY
trial). The poster highlights the need for new strategies to manage
hyperphosphatemia and suggests that tenapanor, with its novel
mechanism of action, could offer a new treatment approach for
patients with CKD on dialysis.
- ePoster #PO0376, entitled "Tolerability of Tenapanor, an
Investigational, First-in-Class, Non-Binder Therapy for the Control
of Serum Phosphorus in Patients with CKD on Dialysis,"
presents an in-depth analysis of the tolerability profile of
tenapanor across three pivotal clinical studies, BLOCK, PHREEDOM,
and AMPLIFY, concluding that tenapanor was generally well tolerated
in all studies and that the overall gastrointestinal tolerability
of tenapanor is consistent with its novel mechanism of action.
Kyowa Kirin Poster Presentations:
- ePoster #PO0382, entitled "Dose-Response Efficacy and
Tolerability of Tenapanor on Hyperphosphatemia in Japanese
Hemodialysis Patients: Results of a Randomized Phase 2
Study," concludes that tenapanor significantly decreased
serum phosphorus levels in a dose-dependent manner, and was
generally well tolerated across doses in Japanese patients.
Compared to placebo, the 30mg BID dosing groups produced a
statistically significant 2.6 mg/dL mean reduction (p<0.001) in
serum phosphorus from baseline to the end of the six-week treatment
period.
- ePoster #PO0375, entitled "Efficacy and Safety of Add-on
Tenapanor to Phosphate Binders for Refractory Hyperphosphatemia in
Japanese Patients on Hemodialysis: A Phase 2, Double-Blind
Study," concludes that, the efficacy and safety of
tenapanor with phosphate binders was consistent with other studies
conducted in Japan where tenapanor
was administered as a single agent. Compared to placebo and
phosphate binders, treatment with tenapanor and phosphate binders
achieved a statistically significant 2.1 mg/dL mean reduction
(p<0.001) in serum phosphorus, with 87% of patients in the
tenapanor group achieving target phosphorus levels.
All poster presentations are now publicly available and can be
accessed on demand HERE.
In addition to the poster presentations during the ASN Annual
Meeting, an Exhibitor Spotlight presentation, sponsored by Ardelyx,
provides information on advances in the science of phosphate
absorption and clinical data on tenapanor:
"ADVANCING THE SCIENCE OF PHOSPHATE ABSORPTION: Paracellular
Pathway and Implications for Phosphorus Management." Guest
speakers focus on the following topics:
- New Understanding of Phosphate Absorption May Explain
Challenges in Phosphorus Management
PRESENTED BY:
KAMYAR KALANTAR-ZADEH, MD, MPH, PhD,
Professor of Medicine, Pediatrics, Public Health, Epidemiology, and
Nursing Sciences, Chief, Division of Nephrology and Hypertension
and Kidney Transplantation, University of
California, Irvine, School of Medicine
- Tenapanor: An Investigational Therapy for the Treatment of
Hyperphosphatemia
PRESENTED BY: GLENN M. CHERTOW, MD, MPH, Chief, Division of
Nephrology Stanford University School
of Medicine
To view the full presentation, click on the Ardelyx Exhibitor
Spotlight program HERE.
About Tenapanor for Hyperphosphatemia
Tenapanor,
discovered and developed by Ardelyx, is a first-in-class, phosphate
absorption inhibitor currently under review by the FDA (PDUFA date:
April 29, 2021) for the control of
serum phosphorus in adult patients with CKD on dialysis. Tenapanor
has a unique mechanism of action that acts locally in the gut to
inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a
conformational change of the epithelial cell junctions, thereby
significantly reducing paracellular uptake of phosphate at the
primary pathway of phosphate absorption. Tenapanor has been studied
in three Phase 3 clinical trials in the U.S., all of which have met
their primary endpoint and support the potential role of tenapanor
as a foundational treatment in the management of hyperphosphatemia.
In 2017, Ardelyx and Kyowa Kirin entered into a license agreement
that provides Kyowa Kirin exclusive rights to develop and
commercialize tenapanor in Japan
for the treatment of cardiorenal diseases. In Japan, Kyowa Kirin has conducted three Phase 2
trials of tenapanor as KHK7791.
About Hyperphosphatemia
Hyperphosphatemia is a serious
condition resulting in an abnormally elevated level of phosphorus
in the blood that is estimated to affect more than 745,000 dialysis
patients in major developed countries. 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.
Despite treatment with phosphate binders (the only approved therapy
for hyperphosphatemia), 77% of CKD patients on dialysis are unable
to consistently maintain phosphorus levels ≤5.5 mg/dL over a
six-month period (Spherix Global Insights: RealWorld Dynamix,
Dialysis 2019). Phosphorus levels greater than 5.5 mg/dL have been
shown to be an independent risk factor for cardiovascular morbidity
and mortality in patients requiring dialysis (Block 2004), and
internationally recognized treatment guidelines recommend lowering
elevated phosphate levels toward the normal range
(<4.6mg/dL).
About Ardelyx, Inc.
Ardelyx is a biopharmaceutical
company translating scientific breakthroughs into promise for
patients, driven to advance targeted therapies where significant
medical needs persist. We have developed a unique and innovative
platform that has enabled the discovery of new biological
mechanisms and pathways to create targeted, first-in-class, oral,
small molecule therapies to meet these needs. Our lead candidate,
tenapanor, is currently under FDA review for the control of serum
phosphorus in adult patients with chronic kidney disease on
dialysis. Our discovery platform has also led us to the discovery
of a lead candidate in our RDX013 program for the potential
treatment of high potassium, or hyperkalemia, a common condition in
patients with kidney and/or heart disease. For more information,
please visit https://ardelyx.com/.
About Kyowa Kirin Co., Ltd.
Kyowa Kirin commits to
innovative drug discovery driven by state-of-the-art technologies.
The company focuses on creating new values in the four therapeutic
areas: nephrology, oncology, immunology/allergy and neurology.
Under the Kyowa Kirin brand, the employees from 40 group companies
across North America, EMEA, and
Asia/Oceania unite to champion the
interests of patients and their caregivers in discovering solutions
wherever there are unmet medical needs. You can learn more about
the business of Kyowa Kirin at: https://www.kyowakirin.com.
Ardelyx Forward Looking Statements
To 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 for
tenapanor to be approved for marketing by the FDA for the control
of serum phosphorus in chronic kidney disease patients on dialysis.
Such forward-looking statements involve substantial risks and
uncertainties that could cause the development of Ardelyx's product
candidates or 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, the uncertainties associated with the regulatory
approval process, and uncertainties in the drug commercialization
process. 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 quarterly report on Form 10-Q filed with the Securities
and Exchange Commission on August 6,
2020, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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