FREMONT, Calif., Aug. 3, 2020 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), a specialized biopharmaceutical company focused on
developing innovative first-in-class medicines to improve treatment
for people with kidney and cardiovascular diseases, today announced
that tenapanor has been named a finalist in the Fierce Innovation
Awards in the category of biotech innovation in a class of
therapies identified by experts to have potential for significant
impact in the industry. Tenapanor, discovered and developed by
Ardelyx, is a first-in-class therapy for the control of serum
phosphorus in adult patients with chronic kidney disease (CKD) on
dialysis that is supported by three successful Phase 3 studies. The
selection criteria for the award included: effectiveness, technical
innovation, competitive advantage, financial impact, and true
innovation.
![Ardelyx logo (PRNewsFoto/Ardelyx) Ardelyx logo (PRNewsFoto/Ardelyx)](https://mma.prnewswire.com/media/119451/ardelyx_logo.jpg)
"We are thrilled to be recognized for the scientific innovation
that exemplifies tenapanor, especially by the group of
distinguished drug developers from major biopharmaceutical
companies that participated in the award review," said Mike Raab, president and chief executive officer
of Ardelyx. "It is especially rewarding to see that the novel
technological approach underlying tenapanor has translated into a
promising therapeutic for the many patients with hyperphosphatemia.
There is a high unmet need for new therapies that can effectively
control phosphorus levels in patients with CKD on dialysis. These
patients have up to a 38% increase in the relative risk of
hospitalization due to cardiovascular events and up to a 102%
increase in the relative risk of mortality. We are motivated and
inspired by the possibility to help these patients with
tenapanor."
The Fierce Innovation Awards – Life Sciences Edition 2020 is a
peer reviewed awards program from the publisher of Fierce Biotech
and Fierce Pharma. The competition highlights companies that
demonstrated innovative solutions, technologies, and services that
have the potential to make the greatest impact for biotech and
pharma companies. The awards program's applications were reviewed
by an exclusive panel of executives from major biotech and pharma
companies including Astellas, Accenture, AstraZeneca, Angiocrine
Bioscience, Biotech Research Group, NIHR Clinical Research Network,
Medidata Solutions and PPD. Winners will be announced in the 2020
Innovation Report set to publish by Fierce Life Sciences on
September 14, 2020.
About Tenapanor for Hyperphosphatemia
Tenapanor,
discovered and developed by Ardelyx, is a first-in-class,
proprietary, oral medicine for which the company has submitted an
NDA to the FDA for the control of serum phosphorus in adult
patients with CKD on dialysis. Tenapanor has a unique mechanism of
action and 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. Three successful Phase 3 studies
demonstrating tenapanor's ability to reduce phosphate levels, as
either monotherapy or as part of a dual mechanism approach with
phosphate binders, have been reported.
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), approximately 70% of CKD patients on
dialysis continue to experience elevated phosphorus levels at any
point in time (Spherix Global Insights: RealWorld Dynamix, Dialysis
2018). 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 focused on developing
innovative first-in-class medicines to enhance the lives of
patients with kidney and cardiovascular diseases. Ardelyx is
advancing tenapanor, a novel product candidate to control serum
phosphorus in adult patients with CKD on dialysis, for which the
company submitted an NDA to the FDA on June
30, 2020. Ardelyx is also advancing RDX013, a potassium
secretagogue program, for the potential treatment of high
potassium, or hyperkalemia, a problem among certain patients with
kidney and/or heart disease. In addition, Ardelyx received FDA
approval of IBSRELA® (tenapanor) on September 12, 2019. 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 the respective territories.
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 statements regarding the
potential for tenapanor to reduce phosphate levels as either
monotherapy or as part of a dual mechanism approach with phosphate
binders. 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, 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
May 7, 2020, and its future current
and periodic reports to be filed with the Securities and Exchange
Commission.
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