I.V. Triferic Data to
Support Upcoming New Drug Application
Rockwell Medical, Inc. (NASDAQ: RMTI) (“Rockwell Medical” or the
“Company”), a global biopharmaceutical company dedicated to
improving outcomes for patients with end-stage renal disease (ESRD)
and chronic kidney disease (CKD), today announced positive data
from two studies evaluating intravenous (I.V.) and peritoneal
dialysate (PD) formulations of Triferic® (ferric pyrophosphate
citrate), the only therapy approved by the U.S. Food and Drug
Administration (FDA) indicated to replace iron and maintain
hemoglobin in adult hemodialysis (HD) patients with chronic kidney
disease. The data from the studies will be presented at the Annual
Dialysis Conference, the largest multi-disciplinary conference on
dialysis, held March 16-19 in Dallas, Texas.
“We are encouraged by the data from this study, which
demonstrates that I.V. Triferic delivers the same quantity of iron
to patients as Triferic delivered via hemodialysate,” said Raymond
D. Pratt, M.D., Chief Medical Officer of Rockwell Medical. “We
believe Triferic has the potential to transform anemia management
for all patients with hemodialysis-dependent chronic kidney
disease. An I.V. formulation would give us the opportunity to
integrate the use of Triferic at all dialysis centers— in the U.S.
and abroad—regardless of the mode of bicarbonate delivery being
used.”
I.V. Triferic for adult HD patients was developed pursuant to a
Special Protocol Assessment (SPA), at which time the FDA confirmed
that an equivalence approach to Triferic delivered via
hemodialysate (Dialysate Triferic) would be acceptable for I.V.
Triferic. The Company expects to submit a New Drug Application
(NDA) for I.V. Triferic to the FDA during the second quarter of
2019, in which the study below will be submitted for FDA
review.
I.V. Infusion of Triferic Delivers Same Quantity of Iron
as Delivery via Hemodialysate
An open-label, randomized, multiple-period single dose study was
conducted in 24 CKD-5HD patients to establish the equivalence of
doses between dialysate and I.V. administration. Each patient
received a baseline iron treatment and three randomized treatments
of either Triferic 6.75 mg Fe I.V. pre-dialyzer; Triferic 6.75 mg
Fe I.V. post-dialyzer; or Triferic 2 μM (110 μg Fe/L of
hemodialysate). Serum and plasma iron were drawn at specified time
points over 12 hours and analyzed for total iron (Fe) and
Transferrin Bound Iron (TBI). Results from the study were as
follows:
- Intravenous infusion of 6.5 mg iron as ferric pyrophosphate
citrate (FPC) during three hours of hemodialysis delivers the same
quantity of iron as when Triferic is delivered via
hemodialysate;
- In Phase 3 clinical studies, Dialysate Triferic maintained iron
status and hemoglobin concentrations;
- The amount of iron delivered in the pivotal clinical trials for
Dialysate Triferic is now established as 6.5 mg Fe/treatment;
and
- Administration of FPC into the pre-dialyzer blood line extends
the ability to provide Triferic iron to all patients receiving
hemodialysis or hemodiafiltration.
“Triferic administered via dialysate provides a safe and
effective method to replace iron and maintain hemoglobin
concentration in adults living with hemodialysis-dependent chronic
kidney disease,” said Stuart Paul, President and Chief Executive
Officer of Rockwell Medical. “Based upon results from our
equivalency study, which demonstrate consistent results for I.V.
Triferic, we plan to submit our data for review by the FDA as a
part of our NDA. The NDA is expected to be submitted with the
FDA during the second quarter of 2019. Additionally, the delivery
of Triferic to peritoneal dialysis patients via the dialysate may
improve patients’ ability to manage their anemia, typically in the
home setting.”
Intraperitoneal Triferic May Serve as Effective and
Simple Iron Replacement Option for Chronic Peritoneal Dialysis
Patients
In a second study, 30 patients were enrolled in an open-label,
randomized, two-period, single ascending dose study of Triferic
administered in peritoneal dialysis fluid (PDF). Results
demonstrated iron absorption from PDF was dose-dependent with peak
serum iron profile (sFe) at approximately six hours with return to
baseline over the next approximately eight hours. Clearance was
similar to Triferic I.V. administration.
“The iron requirements in patients receiving peritoneal dialysis
are less than hemodialysis patients; however, they still require
supplemental iron to manage their anemia,” said Dr. Pratt. “This
single-ascending dose study shows that Triferic can deliver iron to
the systemic circulation when added to peritoneal dialysis fluid
and may serve as an important means to managing anemia in an
outpatient setting.”
Additional studies of Triferic in peritoneal dialysis patients
will be required prior to submission of an NDA.
About TrifericTriferic is the only FDA-approved
therapy indicated to replace iron and maintain hemoglobin in
hemodialysis patients via dialysate during each dialysis treatment,
Triferic delivers approximately 5-7 mg iron with every hemodialysis
treatment to the bone marrow and maintains hemoglobin without
increasing irons stores (ferritin). Unlike IV iron products,
Triferic binds iron immediately and completely to transferrin
(carrier of iron in the body) upon entry into the blood and is then
transported directly to the bone marrow to be incorporated into
hemoglobin, with no increase in ferritin (stored iron and
inflammation) and no anaphylaxis, addressing a significant medical
need in overcoming Functional Iron Deficiency (FID) in ESRD
patients. Please visit www.triferic.com to view the Triferic
mode-of-action (MOA) video and for more information.
About Rockwell MedicalRockwell Medical is a
biopharmaceutical company targeting end-stage renal disease (ESRD)
and chronic kidney disease (CKD). Rockwell Medical’s exclusive
renal drug therapies support disease management initiatives to
improve the quality of life and care of dialysis patients and are
intended to deliver safe and effective therapy, while decreasing
drug administration costs and improving patient convenience.
Rockwell Medical’s anemia drug Triferic is the only FDA-approved
product indicated for iron replacement and maintenance of
hemoglobin in hemodialysis patients. Rockwell Medical is also an
established manufacturer, supplier and leader in delivering
high-quality hemodialysis concentrates/dialysates (used to maintain
human life by removing toxins and replacing critical nutrients in
the dialysis patient’s bloodstream) to dialysis providers and
distributors in the U.S. and abroad. Please visit
www.rockwellmed.com for more information.
Forward-Looking Statements Certain statements
in this press release may constitute "forward-looking statements"
within the meaning of the federal securities laws, including, but
not limited to, Rockwell's intention to bring to market Triferic,
and IV Triferic. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "could," "plan," "potential," "predict," "forecast,"
"project," "plan", "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are
forward-looking statements. While Rockwell Medical believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release.
These forward-looking statements are based upon current estimates
and assumptions and are subject to various risks and uncertainties
(including, without limitation, those set forth in Rockwell
Medical's SEC filings), many of which are beyond our control and
subject to change. Actual results could be materially different.
Risks and uncertainties include: statements about the timing and
success of our planned NDA filing to be submitted to the FDA for IV
Triferic; the potential market opportunity for IV Triferic and
other Rockwell products; pricing and reimbursement status for IV
Triferic, including eligibility for add-on reimbursement under
TDAPA; liquidity and capital resources; expected duration of
Rockwell Medical's existing working capital; plans, timing and
success of our planned commercialization of Triferic; and timing
and success of our efforts to renegotiate economic terms of our
concentrate business. Rockwell Medical expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Triferic® is a registered trademark of Rockwell Medical,
Inc.
Investor Contact:Lisa Wilson In-Site
Communications, Inc.(917) 543-9932lwilson@insitecony.com
Media Contact:Jerica PittsW2O Group(312)
858-3469jpitts@w2ogroup.com
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