FREMONT, Calif., Nov. 13, 2018 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the New Drug
Application (NDA) for tenapanor for the treatment of patients with
irritable bowel syndrome with constipation (IBS-C). Tenapanor,
Ardelyx's lead product candidate, is a minimally-systemic small
molecule that acts locally in the gastrointestinal (GI) tract to
inhibit the sodium transporter NHE3 and reduce sodium uptake from
the gut.
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Ardelyx's NDA submission is supported by a clinical package
encompassing more than 3,100 patients and healthy volunteers who
have participated in Ardelyx trials and an extensive clinical and
preclinical data package supporting the excellent safety profile.
The data include results from the completed IBS-C registration
T3MPO program, which consisted of two Phase 3 trials, T3MPO-1 and
T3MPO-2, and a long-term safety extension trial, T3MPO-3. Both the
T3MPO-1 and T3MPO-2 trials achieved statistical significance for
their primary endpoint and demonstrated that tenapanor had a
durable effect on reducing constipation and abdominal pain that
patients with IBS-C experience. The favorable safety profile of
tenapanor, which has been shown across all trials, was further
supported by the completed T3MPO-3 study.
About Tenapanor for IBS-C
Tenapanor is a
minimally-systemic small molecule that acts locally in the
gastrointestinal (GI) tract to inhibit the sodium transporter NHE3
and reduce sodium absorption in the GI tract, thus increasing
intestinal fluid. In addition, data from preclinical studies
suggest that tenapanor reduces abdominal pain caused by IBS-C
through the inhibition of TRPV-1 dependent signaling. TRPV-1,
better known as the "hot chili pepper receptor," is a
well-established pain target known for transmitting painful stimuli
from a variety of sources including heat, protons and inflammatory
molecules.
About IBS-C
Irritable bowel syndrome with constipation
(IBS-C) is a GI disorder in which abdominal pain is associated with
constipation, and significantly affects the health and quality of
life of at least 11 million people in the US. A study published in
the American Journal of Gastroenterology in 2015 showed that over
50 percent of IBS-C patients rated their pain, constipation and
straining as being "extremely bothersome." In the same study, GI
symptoms led to an average 4.9 days of "disrupted productivity" and
0.8 days of missed work per month.
About Ardelyx, Inc.
Ardelyx is focused on enhancing
the way people with cardiorenal diseases are treated by developing
first-in-class medicines. Ardelyx's cardiorenal pipeline includes
the Phase 3 development of tenapanor for the treatment of
hyperphosphatemia in people with end-stage renal disease (ESRD) who
are on dialysis and 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 has completed Phase 3 development of tenapanor
for the treatment of irritable bowel syndrome with constipation
(IBS-C) and submitted a New Drug Application to the U.S. Food and
Drug Administration seeking U.S. marketing approval for this
indication. To efficiently bring its treatments to market, Ardelyx
is pursuing strategic collaborations for tenapanor for IBS-C and
hyperphosphatemia in certain territories. Ardelyx has established
agreements with Kyowa Hakko Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit
http://www.ardelyx.com/ and connect with us on Twitter
@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 statements regarding the
potential for Ardelyx's product candidates in treating the diseases
and conditions for which they are being developed. 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 inherent in the clinical
development process, including the regulatory approval 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 November 7,
2018, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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SOURCE Ardelyx