FREMONT, Calif., Oct. 19, 2016 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on gastrointestinal and cardio-renal diseases, today announced the
presentation of positive global endpoint data from its Phase 2b
trial, completed in September 2014,
which evaluated tenapanor for the treatment of patients with
irritable bowel syndrome with constipation (IBS-C). These
pre-specified analyses build off of positive efficacy findings on
the study's primary and key secondary endpoints in the same patient
population, as previously announced in October 2014 and presented at Digestive Disease
Week in 2015. They also further validate the 50 milligram (mg),
twice-daily dose of tenapanor chosen for the two ongoing Phase 3
studies, T3MPO-1 and T3MPO-2, in patients with IBS-C, which are
expected to have data readouts in mid- and late-2017, respectively.
The company is also evaluating tenapanor in a Phase 3 study for the
treatment of hyperphosphatemia in end-stage renal disease (ESRD)
patients on dialysis, with data expected to be reported in the
first quarter of 2017.
William D. Chey, M.D., the
Timothy T. Nostrant professor of
gastroenterology at the University of
Michigan Health System, will present these secondary
endpoint findings in an oral session today during the
American College of Gastroenterology (ACG) Annual Scientific
Meeting and Post Graduate Course.
"In this methodologically rigorous Phase 2b trial, 50 mg of
tenapanor twice a day provided robust benefits for the key symptoms
of IBS-C, including abdominal pain and stool frequency, compared to
placebo," said Dr. Chey. "The results of this trial laid the
groundwork for the ongoing Phase 3 clinical trials of tenapanor in
patients with IBS-C. I eagerly await results of these trials and
hope that tenapanor's unique mechanism of action will expand the
list of options available to treat patients with IBS-C."
The IBS symptom global endpoints in the Phase 2b study included:
adequate IBS symptom relief; improvements in IBS severity,
constipation severity and treatment satisfaction. Compared to
placebo, treatment with 50 mg of tenapanor twice a day resulted in
statistically significant improvements in all global endpoints
measured. Notably, 63.1 percent of patients treated with 50 mg of
tenapanor twice a day reported adequate relief of IBS symptoms
compared to 39.3 percent for patients on placebo (p =
0.002).
Additional clinically meaningful and statistically significant
improvements with tenapanor 50 mg twice-daily dosing compared with
placebo included reduction in IBS severity (p =
0.024); reduction in constipation severity (p <
0.001); increased mean satisfaction score (p <
0.001); and, improvement in the degree of IBS symptom relief
(p < 0.001).
"IBS-C significantly impacts the quality of life of millions of
people, but there are few, effective treatment options today," said
Mike Raab, president and chief
executive officer, Ardelyx. "These data further demonstrate the
potential for tenapanor to effectively improve critical clinical
symptoms in patients with IBS-C, and represent an important
perspective for clinicians in evaluating patients' satisfaction and
tolerability when treating with tenapanor. We look forward to
sharing results from the Phase 3 trials throughout 2017 and believe
that tenapanor's unique mechanism of action will provide a
differentiated option for those affected by IBS-C."
Presentation Details
Title: The Effect of Tenapanor on Global Endpoints in
Patients with Constipation Predominant Irritable Bowel Syndrome:
Results from a 12-Week, Double-Blind, Placebo-Controlled,
Randomized Phase 2b Trial
Date: Wednesday, October 19,
2016
Time: 8:30 a.m. – 8:40 a.m. PDT
Location: The Venetian Hotel, Las
Vegas, NV
Room: Venetian Ballroom E
About Ardelyx, Inc.
Ardelyx is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of innovative,
minimally-systemic, small molecule therapeutics that work
exclusively in the gastrointestinal (GI) tract to treat GI and
cardio-renal diseases. Ardelyx has developed a proprietary drug
discovery and design platform enabling it, in a rapid and
cost-efficient manner, to discover and design novel drug
candidates. Utilizing this platform, Ardelyx has discovered and
designed tenapanor, which it is evaluating for the treatment of
irritable bowel syndrome with constipation (IBS-C) and for the
treatment of hyperphosphatemia in patients with end-stage renal
disease (ESRD) on dialysis. In addition to tenapanor, Ardelyx is
developing RDX227675, a non-absorbed polymer for the treatment of
hyperkalemia, or high potassium, a problem prevalent in patients
with kidney and heart disease. Ardelyx is also advancing several
research programs focused in GI and cardio-renal diseases. Ardelyx
is located in Fremont, Calif. For
more information, please visit Ardelyx's website at
www.ardelyx.com.
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 of
tenapanor in the treatment of IBS-C and the expected timing for the
receipt of the results from Ardelyx's two on-going Phase 3 clinical
trials evaluating tenapanor for the treatment of IBS-C and the
expected timing for the receipt of the results from Ardelyx's
on-going Phase 3 clinical trial evaluating tenapanor for the
treatment of hyperphosphatemia. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
development of tenapanor 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. 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 8, 2016, and its future current and
periodic reports to be filed with the Securities and Exchange
Commission.
Logo - http://photos.prnewswire.com/prnh/20140619/119451
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ardelyx-announces-the-presentation-of-positive-global-endpoint-findings-from-phase-2b-trial-of-tenapanor-in-patients-with-ibs-c-at-acg-annual-meeting-300347276.html
SOURCE Ardelyx