FREMONT, Calif., Sept. 13, 2018 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), today announced the submission of its New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
requesting U.S. marketing authorization of 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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"This NDA submission represents an important advancement in the
treatment of people with IBS-C," said William Chey, M.D., professor gastroenterology
and nutrition at the University of
Michigan and an investigator in Ardelyx's IBS-C clinical
trials. "Despite the high prevalence of this disorder and the
extremely burdensome symptoms associated with it, there are limited
treatment options available. Current FDA approved treatments work
to alleviate constipation through the secretion of chloride in the
GI tract, and improve symptoms in only some patients. If approved,
tenapanor would be the first medication available that works by
reducing sodium uptake from the gut. The resulting increased fluid
in the gut softens stools and improves bowel regularity. In
addition, in clinical trials, tenapanor has demonstrated a
statistically significant reduction in pain associated with IBS-C,
a critical and difficult-to-manage symptom for these patients. In
preclinical work, Ardelyx found that this reduction in pain is
associated with the inhibition of TRPV-1 dependent signaling, which
is unique from other current IBS-C therapies. I believe tenapanor
has the potential to be an important new treatment and look forward
to the potential opportunity to use it with my patients in the
future."
"We are excited to have submitted our first NDA, which is the
culmination of eight years of work by our team and a commitment
from patients and our investigators, to whom we are very thankful,"
said Mike Raab, president and chief
executive officer of Ardelyx. "Tenapanor has demonstrated clear
efficacy and tolerability in our Phase 3 clinical program. With its
novel mechanism of action, we believe it could make a significant
difference in the lives of patients who struggle with the symptoms
of IBS-C and provide physicians a new option for treating their
patients. If accepted, our partners, Knight Therapeutics and Fosun
Pharma will be able to leverage our NDA, bringing them closer to
filing in their territories and launching tenapanor for IBS-C in
Canada and China. We will continue to evaluate additional
collaborations to bring tenapanor to patients and physicians in
the United States and around the
world who need another treatment option."
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.
Based on standard FDA review timelines, Ardelyx expects to
receive notification of acceptance of the filing for substantive
review before the end of the year.
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 renal diseases are treated by
developing first-in-class medicines. Ardelyx's renal
pipeline includes the Phase 3 development of tenapanor for the
treatment of hyperphosphatemia in people with end-stage renal
disease 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 the potential for
Ardelyx's product candidates in treating the diseases and
conditions for which they are being developed and Ardelyx's
expected timing for receipt of notification from the FDA of
acceptance for substantive review of Ardelyx's NDA for tenapanor
for the treatment of IBS-C. 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 August 7, 2018, and its future current and
periodic reports to be filed with the Securities and Exchange
Commission.
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