FREMONT, Calif., July 14, 2015 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on gastrointestinal and cardio-renal diseases, today announced that
the Company will provide a detailed overview of its development
programs at its inaugural R&D Day, which is being held today
from 8:00a.m. to 11:30a.m. EDT in
New York City.
"We have transformed Ardelyx into a company that has a balanced
pipeline with multiple, wholly-owned programs spanning all stages
of development across our primary areas of therapeutic focus,
gastrointestinal and cardio-renal diseases. Following our
reacquisition of the global rights for tenapanor from AstraZeneca
and our recent financing that raised $78M, we are advancing this pipeline and expect
to have, by the end of 2015, an ongoing Phase 3 program in IBS-C, a
Phase 2b program for patients on dialysis with hyperphosphatemia
and will have made significant progress on our development program
for RDX022, our non-absorbed potassium binder," said Mike Raab, President and Chief Executive
Officer.
"By year-end 2016, we anticipate having three ongoing Phase 3
clinical programs for what we believe will be best-in-class
treatments for IBS-C, hyperphosphatemia, and hyperkalemia,"
Mike Raab continued. "This is an
exciting time for the Company as we advance multiple clinical
programs, and look towards the next phase of our evolution and the
potential commercialization of our own products."
At its inaugural R&D Day, Mr. Raab will review Ardelyx's
overall strategy and the Company's RDX022 potassium-binding polymer
for the treatment of hyperkalemia. David Rosenbaum, Ph.D., Senior Vice President
Drug Development, will review tenapanor clinical data and
development plans. Jeremy Caldwell,
Ph.D., Executive Vice President and Chief Scientific Officer, will
review several research programs, including RDX009, a TGR5 agonist
that stimulates local secretion of GLP-1 and GLP-2 in the gut, the
preclinical evidence demonstrating gut repair and healing with
RDX009 and ongoing plans to evaluate RDX009 in several potential
indications including its utility in the treatment of
chemotherapy-induced diarrhea. Dr. Caldwell will also provide a
comprehensive overview of the Company's proprietary drug discovery
and design platform.
Ardelyx's executive management team will be joined by
Geoffrey A. Block, M.D., Associate
Clinical Professor in Medicine at the University of Colorado Health Sciences Center. Dr.
Block will provide his perspectives on new and emerging therapies
for the treatment of hyperphosphatemia and hyperkalemia.
Overview of Ardelyx's Research and Development
Programs
Tenapanor for Constipation-Predominant Irritable Bowel
Syndrome (IBS-C)
- Following the reacquisition of global rights for tenapanor from
AstraZeneca (NYSE:AZN, LON:AZN) in June
2015, the Company intends to initiate a Phase 3 clinical
program in patients with IBS-C in the fourth quarter of 2015.
- The Company will present new data from its previously reported
Phase 2b IBS-C clinical study demonstrating that the sustained
overall responder rate was 14.6 percent greater than the placebo
group. A sustained overall responder is a patient who has (i) an
increase of ≥1 CSBM from baseline and ≥3 CSBM and (ii) a decrease
of 30% mean abdominal pain from baseline, both during the same week
for 9 of 12 weeks and 3 of the last 4 weeks.
Tenapanor for ESRD Hyperphosphatemia in Dialysis
Patients
- The Company will present results of an exploratory analysis of
its initial Phase 2b trial in patients with hyperphosphatemia
demonstrating a significant decrease of FGF-23.
- The Company plans to commence a Phase 2b clinical trial in
patients with hyperphosphatemia on dialysis in the fourth quarter
2015 to evaluate dosing regimens and expects results from this
trial in the second half of 2016.
RDX022, a Potassium-Binding Polymer to Treat
Hyperkalemia
- Ardelyx expects to initiate, in the fourth quarter of 2015, a
pharmacodynamic (PD) study for RDX022, which is currently
undergoing early-stage human trials. This new study will
evaluate safety and PD effects of RDX022 and results are expected
in the first half of 2016.
- The Company has met with the FDA and, based on those
discussions, intends to pursue an accelerated 505(b)2 development
pathway for RDX022. Additionally, the Company expects to
initiate a Phase 3 clinical trial to evaluate RDX022 for the
treatment of hyperkalemia in the second half of 2016.
RDX009, a Locally-Acting GLP-1 & GLP-2
Secretagogue
- The Company will present new data for RDX009, a TGR5 agonist
that stimulates local secretion of GLP-1 and GLP-2 in the
gut. The Company targets an IND filing for RDX009 in the
second half of 2016.
- While Ardelyx continues to evaluate various potential
indications for RDX009, it is currently most encouraged about
recent preclinical studies demonstrating its potential in
chemotherapy-induced diarrhea.
RDX013, a potassium secretagogue
- The Company will present proof-of-concept data demonstrating
potassium secretion in a pre-clinical model.
Additional new programs
- The Company today announced a new program based on its growing
understanding of the broad and complex biology, mechanisms and
physiology involved in NHE3 modulation, building upon its
leadership position in this area.
- In addition, the Company is initiating two new programs in the
GI and cardio-renal fields based on the Company's proprietary drug
discovery and design platform.
The R&D Day presentation will be available through a live
audio webcast accessible through a link in the investor relations
section of the Ardelyx website at ir.ardelyx.com. A replay of the
webcast will be available for 30 days on the website after the
presentation.
About Ardelyx
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 tract to treat gastrointestinal
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, the Company has discovered and
designed tenapanor, which it is evaluating for the treatment of
IBS-C and hyperphosphatemia in chronic kidney disease patients on
dialysis. In addition to tenapanor, Ardelyx is developing RDX022, a
non-absorbed polymer for the treatment of hyperkalemia, or high
potassium, in kidney and heart disease patients, and has discovered
small molecule NaP2b inhibitors for the treatment of
hyperphosphatemia in CKD patients on dialysis, a program licensed
to Sanofi. Ardelyx is also independently advancing several
research programs focused in gastrointestinal and cardio-renal
diseases. Ardelyx is located in Fremont,
California. 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 for
tenapanor in treating IBS-C patients, the potential for tenapanor
in treating hyperphosphatemia in patients with end stage renal
disease on dialysis, Ardelyx's future development plans for
tenapanor and the timing thereof, the potential for RDX022 in
treating hyperkalemia, Ardelyx's future development plans for
RDX022 and the timing thereof, the potential of RDX009 in treating
chemotherapy induced diarrhea, and the potential timing for filing
an IND for RDX009, and the potential of Ardelyx's drug discovery
and design platform. 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
research and the clinical development process, Ardelyx's reliance
upon AstraZeneca for the timely delivery of clinical trial material
required for the initiation of the Phase 3 clinical program in
IBS-C and the Phase 2b clinical trial in hyperphosphatemia, and
Ardelyx's reliance upon AstraZeneca to facilitate a complete and
timely transition of the tenapanor program from AstraZeneca to
Ardelyx. 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 current report filed on Form 8-K with the
Securities and Exchange Commission on July
14, 2015, and its future periodic reports to be filed with
the Securities and Exchange Commission.
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