Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
renal disease, today announced the publication of results from its
pivotal Phase 3 study evaluating ferric citrate for iron deficiency
anemia (IDA) in non-dialysis-dependent chronic kidney disease
(NDD-CKD) in the online issue of the Journal of the American
Society of Nephrology (JASN).
Ferric citrate (Auryxia®) is currently indicated in the U.S. as
a phosphate binder for the control of serum phosphorus levels in
patients with CKD on dialysis. Data in the publication highlight an
investigational use of ferric citrate as a potential oral treatment
for adults with IDA and NDD-CKD.
The article titled, “Effects of Ferric Citrate in Patients with
Non-Dialysis-Dependent CKD and Iron Deficiency Anemia,” describes
previously reported Phase 3 results, in which ferric citrate
achieved statistically significant results on the primary and all
five pre-specified secondary endpoints for the treatment of IDA in
adults with NDD-CKD versus placebo. Patients enrolled in the trial
had not adequately responded to or could not tolerate prior
treatment with oral iron. In the Phase 3 study, ferric citrate was
generally well tolerated and adverse events were consistent with
its known safety profile, with diarrhea reported as the most common
adverse event.
“The results shown in this pivotal study demonstrated that
ferric citrate, if approved for this indication, could provide an
important new treatment option for people living with chronic
kidney disease and iron deficiency anemia who are not on dialysis,”
said Steven Fishbane, M.D., chief of nephrology for North Shore
University Hospital and Long Island Jewish Medical
Center. “Not only did ferric citrate deliver a clinically
meaningful 1 g/dL increase in hemoglobin levels for the majority
(52.1 percent (61/117)) of patients treated in the Phase 3 study at
any point during the 16-week efficacy period, increases were seen
as early as one to two weeks after start of treatment, and were
sustained for the majority of patients who achieved the primary
endpoint.”
“Clinical trials are critical to the advancement of safe and
effective medicines, and we thank the patients, their families and
the renal care teams who have participated in clinical trials for
ferric citrate,” said John Neylan, M.D., chief medical officer of
Keryx Biopharmaceuticals. “We are pleased to have these data
highlighted by a major nephrology journal, which can provide broad
access for nephrologists to the Phase 3 results. We recently
submitted a supplemental new drug application with these data to
the U.S. FDA. If approved for this expanded indication, ferric
citrate would be the first oral medicine approved by the FDA for
the treatment of iron deficiency anemia in patients with
NDD-CKD.”
About Iron Deficiency Anemia, NDD-CKDIron
deficiency anemia is a common complication in patients with
non-dialysis dependent chronic kidney disease (NDD-CKD), and the
prevalence and severity of IDA increases as kidney disease
progresses. It is estimated that there are approximately 1.6
million people living in the U.S. with stage 3-5 non-dialysis
dependent chronic kidney disease and iron deficiency anemia.
Efficacy and tolerability of current oral iron supplements
are mixed. Intravenous (IV) iron administration is associated with
important risks and burdens.
About the Pivotal Phase 3 Clinical StudyThe
pivotal Phase 3 study randomized 234 patients (233 patients
received at least one starting dose of ferric citrate) at 32
clinical sites in the United States. NDD-CKD patients with
hemoglobin levels between 9.0 g/dL and 11.5 g/dL and who were
intolerant to or had inadequate response to oral iron supplements
were randomized 1:1 (ferric citrate versus placebo), n=117 and
n=116, respectively. Patients enrolled in the study were not
allowed to receive any IV or oral iron, or ESAs during this study.
The study had a 16-week, randomized, double-blind,
placebo-controlled, efficacy period followed by an 8-week
open-label safety extension period in which all patients remaining
in the study, including the placebo group, received ferric citrate.
During the 16-week efficacy period, ferric citrate was administered
at a starting dose of three tablets per day with food and could be
titrated every four weeks by an additional three tablets for up to
a maximum of 12 tablets per day; the mean dose received in ferric
citrate treated patients was 5 tablets per day. The primary
endpoint was the proportion of patients achieving a ≥1 g/dL
increase in hemoglobin at any point during the 16-week efficacy
period. Baseline laboratory values were similar between the
treatment arms.
Use of ferric citrate in patients with NDD-CKD and IDA, as
highlighted above, is investigational and has not been determined
to be safe or efficacious.
About Auryxia Auryxia (ferric citrate) was
approved by the U.S. Food and Drug Administration on September 5,
2014 and is indicated in the U.S. for the control of serum
phosphorus levels in patients with CKD on dialysis. The U.S.
approval of Auryxia was based on data from the company's Phase 3
registration program in dialysis patients. In the Phase 3 clinical
trials, Auryxia effectively reduced serum phosphorus levels to
within the KDOQI guidelines range of 3.5 to 5.5 mg/dL.
Auryxia binds with dietary phosphate in the GI tract and
precipitates as ferric phosphate. The unbound portion of Auryxia
has been shown to increase serum iron parameters including ferritin
and transferrin saturation (TSAT). Iron absorption from Auryxia may
lead to excessive elevations in iron stores. Accordingly,
physicians should assess and monitor iron parameters before
starting and while on Auryxia, and may need to decrease or
discontinue IV iron for these patients. The most common adverse
events for Auryxia treated patients were gastrointestinal related,
including diarrhea, nausea, vomiting and constipation. For more
information about Auryxia and the U.S. full prescribing
information, visit www.Auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric
citrate)Contraindication: Patients
with iron overload syndrome, e.g. hemochromatosis, should not take
Auryxia®.
Iron Overload: Iron absorption from
Auryxia may lead to increased iron in storage sites. Iron
parameters should be monitored prior to and while on Auryxia.
Patients receiving IV iron may require a reduction in dose or
discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental
overdose of iron containing products is a leading cause of fatal
poisoning in children under 6 years of age. Keep Auryxia away
from children as it contains iron. Call a poison control
center or your physician in case of an accidental overdose in a
child.
Patients with Gastrointestinal Bleeding or
Inflammation: Safety has not been established for
these patients.
Adverse Events: The most common adverse
events with Auryxia were diarrhea (21%), nausea (11%), constipation
(8%), vomiting (7%) and cough (6%). Gastrointestinal adverse
reactions were the most common reason for discontinuing Auryxia
(14%). Auryxia contains iron and may cause dark stools, which is
considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be
taken at least 1 hour before Auryxia. Ciprofloxacin should be
taken at least 2 hours before or after Auryxia.
For Full Prescribing Information for Auryxia, please
visit http://auryxia.com/important-safety-information/
Forward Looking StatementsSome of the
statements included in this press release, particularly those
regarding ongoing clinical development of Auryxia, the submission
of an sNDA to the FDA to expand the label of ferric
citrate to include the treatment of IDA in adults with stage 3-5
NDD-CKD and the potential approval in this indication and the
impact thereof on Keryx, may be forward-looking statements that
involve a number of risks and uncertainties. For those statements,
we claim the protection of the safe harbor for forward-looking
statements contained in the Private Securities Litigation Reform
Act of 1995. Among the factors that could cause our actual results
to differ materially are the following: the risk that
the FDA may not concur with our interpretation of our
Phase 3 study results in NDD-CKD, supportive data, conduct of the
studies, or any other part of our regulatory submission and could
ultimately deny approval of ferric citrate for the treatment of IDA
in adults with stage 3-5 NDD-CKD; the risk that if approved for use
in NDD-CKD that we may not be able to successfully market Auryxia
for use in this indication; our ability to continue to supply
Auryxia following the recent resupply to the market; and other risk
factors identified from time to time in our reports filed with
the Securities and Exchange Commission. Any forward looking
statements set forth in this press release speak only as of the
date of this press release. We do not undertake to update any of
these forward-looking statements to reflect events or circumstances
that occur after the date hereof. This press release and prior
releases are available at http://www.keryx.com. The
information found on our website is not incorporated by reference
into this press release and is included for reference purposes
only.
About Keryx Biopharmaceuticals, Inc.Keryx
Biopharmaceuticals, Inc., with headquarters in Boston, MA is a
commercial stage company focused on bringing innovative medicines
to people with renal disease. Keryx developed and commercializes
Auryxia® (ferric citrate), an iron-based phosphate binder, in the
U.S. Ferric citrate is marketed as Riona® by its Japanese
partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In
September 2015, the European Commission granted European market
authorization for Fexeric® (ferric citrate coordination
complex). Keryx has programs to leverage its development and
commercial infrastructure, including evaluation of iron
deficiency anemia in adults with non-dialysis dependent
chronic kidney disease and in-licensing medicines for renal
disease. For more information about Keryx, please
visit www.keryx.com.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Vice President, Corporate Affairs
T: 617.466.3519
amy.sullivan@keryx.com
Lora Pike
Senior Director, Investor Relations
T: 617.466.3511
lora.pike@keryx.com
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