FREMONT, Calif., Oct. 8, 2018 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), today announced that new data from its long-term
safety trial of tenapanor for irritable bowel syndrome with
constipation (IBS-C), the T3MPO-3 trial, were presented this
weekend at the American College of Gastroenterology (ACG) 2018
Annual Meeting. The poster (P0338), titled "An Open Label Long-Term
Safety Trial (T3MPO-3) of Tenapanor in Patients with Irritable
Bowel Syndrome with Constipation (IBS-C)," was recognized as a
Presidential Poster at this year's meeting, a recognition that
fewer than five percent of accepted abstracts receive for high
quality, novel, unique and interesting research. 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.
Ardelyx recently submitted a New Drug Application for marketing
authorization of tenapanor for the treatment of people with IBS-C
to the U.S. Food and Drug Administration, which was supported by a
robust set of nonclinical studies and an extensive clinical data
package in more than 3,100 people supporting the efficacy and
safety profile of tenapanor. 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 the long-term safety
extension trial, T3MPO-3. Both the T3MPO-1 and T3MPO-2 trials
achieved statistical significance for their primary endpoint and
demonstrated the ability of tenapanor to have a durable effect on
reducing the 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.
The T3MPO-3 trial enrolled a total of 240 patients who completed
either the T3MPO-1 or T3MPO-2 Phase 3 trials. All participants in
T3MPO-3 received 50 mg of tenapanor twice-daily for up to 55 weeks.
Importantly, results from T3MPO-3 showed a mean compliance rate
with tenapanor of approximately 98 percent. Overall, tenapanor was
well-tolerated, with the most common adverse event being diarrhea
(9.2%). There were limited discontinuations (2.1%), with only 1.7
percent of patients discontinuing due to diarrhea.
"Tenapanor offers a novel inhibitor of the gastrointestinal
sodium hydrogen exchanger, NHE3, which has been shown to be
effective in patients suffering with IBS-C," said Anthony Lembo, M.D., associate professor of
medicine at Harvard Medical School and
director of the GI Motility Center at Beth Israel Deaconess Medical
Center. "The safety and tolerability data from this study, as well
as the efficacy and tolerability demonstrated in the T3MPO program,
suggest that tenapanor could make a meaningful impact in patients'
lives. I look forward to the potential opportunity to use tenapanor
in practice with my patients in the future."
"The T3MPO-3 data further enhance our confidence in the
approvability of tenapanor for people with IBS-C, and its potential
role as a highly differentiated treatment for this incredibly
burdensome disorder," said David P.
Rosenbaum, Ph.D., chief development officer of Ardelyx. "We
are delighted that these data have been recognized as a
Presidential Poster, an honor ascribed to fewer than 5 percent of
all abstracts at the congress. Tenapanor offers a completely new
mechanism of action that works by reducing sodium uptake from the
gut, rather than through secretion of chloride in the GI tract.
This, combined with our preclinical evidence that tenapanor reduces
pain associated with IBS-C through the inhibition of TRPV-1
signaling, supports its potential to change the way patients who
suffer from the life-altering symptoms of IBS-C are treated. We are
excited to have submitted our NDA in September and look forward to
the possibility of providing IBS-C patients with an alternative
medication for those who may need it."
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 belief
regarding the approvability 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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