Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
renal disease, announced presentation of additional data from its
pivotal Phase 3 study for iron deficiency anemia (IDA) and
non-dialysis dependent chronic kidney disease (NDD-CKD) in four
posters at the American Society of Nephrology’s 2016 Kidney Week
taking place November 15-20 in Chicago. Data in the posters
highlight an investigational use of ferric citrate as a potential
oral treatment for adults with IDA and NDD-CKD. These results are a
more detailed presentation of top line results announced in March
2016.
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.
Taken together, data in the posters demonstrate that in the
Phase 3 trial, the majority of patients treated with ferric
citrate, 52.1 percent (61/117), achieved the primary endpoint of ≥1
g/dL increase in hemoglobin at any point during the 16-week
efficacy period, 93.4 percent (57/61) of whom had a sustained
treatment effect. Increases in hemoglobin in ferric-citrate treated
patients were observed as early as one to two weeks after the start
of treatment. Efficacy results were consistent across groups with
different baseline characteristics. These results were achieved
without the concomitant use of erythropoietin-stimulating agents
(ESAs) or intravenous (IV) iron. Adverse events were generally
similar between treatment arms and consistent with the safety
profile described in the U.S. prescribing information for Auryxia,
with gastrointestinal (GI) disorders as the most common adverse
event. Serum phosphorus levels stayed within target ranges for
CKD.
“I’m pleased to have been involved in this pivotal Phase 3 study
of ferric citrate,” said Steven Fishbane, M.D., chief of nephrology
for North Shore University Hospital and Long Island Jewish Medical
Center. “The data presented today at Kidney Week continue to
underscore ferric citrate’s ability to increase iron stores and
hemoglobin in patients with CKD and IDA, and support its potential
utilization in non-dialysis dependent chronic kidney disease, if
approved by the FDA for this indication.”
“People with chronic kidney disease suffer from a range of
complications, including two that are very common,
hyperphosphatemia and iron deficiency anemia,” said John Neylan,
M.D., chief medical officer of Keryx Biopharmaceuticals. “We are
pleased to have the opportunity to further characterize the pivotal
phase 3 trial results of ferric citrate’s investigational use in a
scientific forum. These data support our goal to expand ferric
citrate’s label and we look forward to submitting the sNDA for IDA
in NDD-CKD patients to the FDA.”
About NDD-CKD, Iron Deficiency AnemiaIron
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(1).
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 mg/dL and 11.5 mg/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.
Poster PresentationsFour posters presented
during Kidney Week are related to the Phase 3 clinical trial.
- Effects of ferric citrate in adults with non-dialysis
dependent chronic kidney disease and iron deficiency anemia: Phase
3 Clinical Trial, Stephen Fishbane, M.D., co-chair of the
Phase 3 trial and division chief, kidney disease and hypertension
at North Shore University Hospital/Long Island Jewish Medical
Center
- Hemoglobin response to ferric citrate in subjects with
non-dialysis dependent chronic kidney disease and iron deficiency
anemia: Data from a Phase 3 clinical trial, Glenn Chertow,
M.D., M.P.H., co-chair of the Phase 3 trial and professor of
medicine and chief, division of nephrology at Stanford
University School of Medicine;
- Effects of ferric citrate on parameters of mineral and
bone metabolism in patients with non-dialysis dependent chronic
kidney disease treated for iron deficiency anemia,
Geoffrey Block, M.D. co-chair of the Phase 3 trial and director of
clinical research at Denver Nephrology
- Predictors of hemoglobin response to ferric citrate in
patients with non-dialysis dependent chronic kidney disease and
iron deficiency anemia, Pablo Pergola, M.D., Ph.D., of
Renal Associates in San Antonio, Texas.
Summary of Phase 3 trial data presented in four poster
presentationsAn analysis of the 16-week randomized
efficacy period of the Phase 3 data study of ferric citrate (FC)
dosed to improve hemoglobin levels showed that ferric citrate was
well tolerated. 52.1 percent (61/117) of ferric citrate treated
patients achieved the primary endpoint without the use of IV iron
or ESA compared to 19.1 percent in the placebo group. Of the
patients in the ferric citrate treatment group who achieved the
primary endpoint, 93 percent (57/61) had a sustained treatment
effect as defined by a mean change from baseline of ≥0.75 mg/dL
over any 4-week time period provided that an increase of >1.0
g/dL had occurred during that 4-week period. Increases in
hemoglobin were observed as early as one to two weeks after the
start of treatment with ferric citrate. Additional analyses of
patients at the end of the 16-week efficacy period were conducted
and reported in the posters that showed:
- A mean relative change of ferric citrate versus placebo of 18.4
percent in TSAT and 170.3 ng/mL in ferritin, which are two measures
of iron stores; iron deficiency anemia develops when a body’s iron
stores are low.
- Baseline characteristics, including severity of anemia, CKD
stage, age, and gender, were not associated with hemoglobin
response.
- Ferric citrate modestly improved markers of bone and mineral
disease, including serum phosphate, serum parathyroid hormone (PTH)
levels, and Fibroblast Growth Factor 23 (FGF 23) – a protein that
is elevated in CKD and is associated with cardiovascular morbidity.
Serum phosphorus levels decreased by 0.43 mg/dL in the ferric
citrate group and by 0.22 g/dL in the placebo group. Adverse events
of hypophosphatemia occurred in one patient receiving ferric
citrate and three placebo patients. There were no discontinuations
in the study due to hypophosphatemia. Phosphorus levels of < 2.0
mg/dL occurred infrequently during ferric citrate treatment – in
two patients in the ferric citrate group during the 16 week
randomized period and another patient in the safety extension
phase. Phosphorus levels rapidly restored to normal levels with
dose reduction, per protocol of the Phase 3 study.
- Patients who switched from placebo to ferric citrate during the
8-week, open label safety extension phase experienced therapeutic
responses in hemoglobin, ferritin, TSAT, and serum phosphate
similar to those initiating ferric citrate at the start of the
trial. 86 patients from the ferric citrate group and 81 patients
from the placebo group entered the extension period and, per
protocol, started on the same ferric citrate dose of three tablets
per day. Serious adverse events occurred in 3.5 percent of patients
who continued on the FC group and 11.1 percent of patients who
rolled over from the placebo group.
- Ferric citrate was well tolerated with up to 16 weeks of
dosing. Adverse events were mild to moderate. The most common
adverse events occurring in >5 percent of patients in either
treatment group were diarrhea, constipation, discolored feces,
nausea and abdominal pain. Rates of serious adverse events did not
differ between ferric citrate and placebo treated groups. Serious
adverse events occurred in 12.0 percent of the ferric citrate group
and 11.2 percent in the place group. Overall, safety data were
consistent with previously reported Phase 3 topline results and
previous clinical experience with ferric citrate in the
hemodialysis setting.
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.
1McClellan et al. Curr Med Res Opin. 2004;20(9):1501-1510.
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 Statements Some of the
statements included in this press release, particularly those
regarding the commercialization and ongoing clinical development of
Auryxia, 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: whether we can increase adoption of
Auryxia in patients with CKD on dialysis; the risk that the FDA may
not concur with our interpretation of our Phase 3 study results in
non-dialysis dependent (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; 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, with headquarters in Boston, is focused on
bringing innovative medicines to market for people with renal
disease. In December 2014, the company launched its first
FDA-approved medicine, Auryxia® (ferric citrate) in the United
States. In January 2014, ferric citrate was approved for use
in Japan, where it is being marketed as Riona® by Keryx's 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).
For more information about Keryx, please visit www.keryx.com.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Vice President, Strategic Operations and 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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