FREMONT, Calif., Jan. 5, 2016 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on gastrointestinal and cardio-renal diseases, today announced
positive results of an open label clinical study evaluating the
pharmacodynamic (PD) activity of RDX022 in healthy adult
volunteers. The study demonstrated that RDX022, Ardelyx's
proprietary potassium binder for the treatment of hyperkalemia,
effectively binds potassium in the gastrointestinal tract
supporting plans to proceed with a Phase 3 clinical program
currently expected to begin in the second half of 2016. RDX022 was
generally well-tolerated at all doses administered (up to 27.5
g/day) in the study.
![Ardelyx logo Ardelyx logo](http://photos.prnewswire.com/prnvar/20140619/119451)
"The magnitude of effect seen with RDX022 in healthy adults
supports our belief that, if approved following the completion of
the Phase 3 clinical program, RDX022 will be an important agent in
treating patients with hyperkalemia. We believe that RDX022
may be able to address many of the limitations of current and
recently approved therapies due to the absence of sodium as a
counter-ion in RDX022 as well as its improved palatability," said
Mike Raab, President and Chief
Executive Officer of Ardelyx. "We have leveraged the long-standing
experience of our management team in creating, developing, and
commercializing polymer-based drugs to create a proprietary,
differentiated potassium binder that we believe can be brought to
market utilizing the 505(b)(2) regulatory pathway. We look
forward to starting a Phase 3 clinical program in the second half
of 2016. We are fully committed to developing high-impact and
important products for patients with cardio-renal diseases. We
believe that RDX022 will complement our efforts with tenapanor, our
small molecule drug candidate currently in Phase 2b for the
management of hyperphosphatemia in dialysis patients."
Results from the PD study
This open-labeled pharmacodynamic (PD) study of RDX022 consisted
of a two-day treatment-free baseline period and a four-day
treatment period. The study included four cohorts, and in
each cohort, 12 subjects received RDX022 and three subjects
received a similar dose of sodium polystyrene sulfonate (SPS) for a
total of 60 subjects.
RDX022 was administered at 4.6 g BID (9.2 g/day), 6.9 g BID
(13.8 g/day), 4.6 g TID (13.8 g/day) and 9.2 g TID (27.5 g/day),
and resulted in a mean increase of fecal potassium from baseline of
888 mg/day, 1,791 mg/day, 1,408 mg/day, and 1,670 mg/day,
respectively. RDX022 was generally well-tolerated at all doses and
demonstrated comparable results to those observed with sodium
polystyrene sulfonate (SPS). Other fecal electrolytes were
monitored during the study and no unexpected changes were observed;
in particular, fecal magnesium remained unchanged from baseline.
The results of the study will be presented in a future
scientific format.
Mr. Raab also noted, "As we considered alternatives, we made the
decision to formulate RDX022 with a calcium counter-ion. Given that
we are trying to accomplish the management of hyperkalemia in
chronic kidney disease and heart failure patients, we believe
calcium is a more appropriate counter-ion than is sodium. It
is clear that increasing the daily intake of sodium in these
patients is counter to best clinical practice. Additionally,
we have focused on improving both the physical properties of the
polymer and the formulation of RDX022. Our goal for RDX022 is
to develop as optimal a potassium binder as possible by combining
innovation with existing technologies in a delivery form that aims
to improve patient adherence and compliance. We believe these
qualities would provide RDX022 with the potential to give us an
advantage in this growing and important marketplace," commented Mr.
Raab.
About RDX022
RDX022 is Ardelyx's proprietary oral, non-absorbed,
potassium-binding polymer based on polystyrene sulfonate, a
well-known and well-characterized polymer, also known as
Kayexalate®. Ardelyx has made numerous improvements to the
polymer by engineering into RDX022 several key physical and
chemical modifications in an effort to improve various properties.
In a separate single center, randomized, crossover study to
evaluate various oral formulations of RDX022 in healthy subjects,
RDX022 consistently outperformed SPS in all aspects of the taste
assessments, including mouth feel, texture and flavor.
Ardelyx has filed a patent application covering the composition of
matter of these modifications.
Plans for RDX022
In the second half of 2016, Ardelyx expects to initiate a Phase
3 clinical program for RDX022. The Phase 3 clinical study
will enroll patients with chronic kidney disease (CKD), with or
without heart failure (HF), who are taking drugs that inhibit the
renin-angiotensin-aldosterone system (RAAS) and are diagnosed with
hyperkalemia, a common side effect that occurs with patients taking
those drugs.
Based on discussions with the FDA, the Company is pursuing a
505(b)(2) regulatory pathway for RDX022.
About Hyperkalemia
Hyperkalemia is defined as the presence of blood potassium
levels greater than 5.0 mEq/L. Normal levels are 3.5 to 5.0 mEq/L.
When hyperkalemia is severe, or above 7.0 mEq/L, there is a
significantly increased risk of death because of the potential for
heart conductance problems.
Hyperkalemia can be caused by a variety of sources. Kidney
disease can result in the build-up of potassium in the blood. Also,
certain drugs such as the common blood pressure medications known
as RAAS inhibitors, can cause hyperkalemia. RAAS inhibitors, though
quite effective for controlling blood pressure, are often
significantly reduced in patients, such as in those with CKD and
HF, whose potassium levels are elevated because of the fear that
elevated potassium can cause significantly worse problems than
hypertension including sudden cardiac arrest in severe cases.
Reports in the literature suggest that hyperkalemia may affect
about 900,000 individuals with CKD Stage 3b or Stage 4 as well as
up to an additional 900,000 patients with heart failure in
the United States. The Company's
proprietary research also suggests that up to 200,000 patients with
ESRD could benefit from an agent that treats
hyperkalemia.
Conference Call & Webcast Information
Ardelyx management will host a live conference call and
webcast today at 8:00 am Eastern Time to discuss the RDX022
clinical trial results. The live webcast and a replay can be
accessed by visiting Ardelyx's website on the investor
page of the Company's website at http://ir.ardelyx.com/.
Please connect to the Company's website at least 15 minutes
prior to the live webcast to ensure adequate time for any software
download that may be needed to access the webcast. Alternatively,
please call (855) 296-9612 (US) or (920) 663-6277 (International)
to listen to the live conference call. The conference ID number for
the live call is 19315898. Please dial in approximately 10 minutes
prior to the call. Following the webcast, an archived version of
the call will be available thirty days.
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, Ardelyx has discovered and designed tenapanor,
which it is evaluating for the treatment of
constipation-predominant irritable bowel syndrome (IBS-C) and for
the control of hyperphosphatemia in CKD 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. Ardelyx is also 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 RDX022 in treating hyperkalemia in kidney and heart disease
patients, Ardelyx's future development plans for RDX022 and the
timing and regulatory plans in connection with such development,
the expected timing for the commencement of the RDX022 Phase 3
clinical study, and the design of the RDX022 Phase 3 clinical
study. Such forward-looking statements involve substantial risks
and uncertainties that could cause the development of RDX022, 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 and the uncertainties in the
manufacture of clinical trial material, including process
development and scale up of manufacturing
processes. 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 12, 2015, and its future current
and periodic reports to be filed with the Securities and
Exchange Commission.
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