Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical
company dedicated to transforming the treatment of iron deficiency
and anemia management and improving outcomes for patients around
the world, today announced the publication of results in the
Journal of Bioequivalence & Bioavailability from a study
designed to investigate the co-administration of intravenous (IV)
Ferric Pyrophosphate Citrate (FPC, Triferic
®) with
unfractionated heparin (UFH) as an admixture via the HD-machine
syringe pump. The study demonstrated no clinically relevant
drug-drug interaction between FPC and UFH on the effects of UFH nor
on the ability of FPC to deliver bioavailable iron when these
agents are co-administered as a single admixture via an HD-machine
syringe pump.
“These findings are significant because they
demonstrated no clinically relevant drug-drug interaction between
FPC and unfractionated heparin, the latter of which has long been
the standard to provide anticoagulation in patients on
hemodialysis,” said Marc Hoffman, M.D., Chief Medical Officer
of Rockwell Medical. “Furthermore, the findings confirm
results of a previous study which used a population pharmacokinetic
model for anti-Xa activity to confirm the effective
anti-coagulation dose of UFH and are consistent with our clinical
experience of FPC in the real-world setting, in which more than
1.6mm million doses have been safely administered.”
The prospective, single-center, open-label,
three-period, crossover trial was conducted to investigate the
ability of an FPC/UFH admixture to maintain adequate
anticoagulation of the dialyzer circuit and to assess the impact of
administration of the admixture on the iron delivery of FPC in
patients with Hemodialysis Dependent Chronic Kidney Disease
(HDD-CKD). The study investigated three treatment regimens in
randomized sequence. Anti-Xa activity, activated prothrombin time
(aPTT), Thrombin time (TT) and serum iron parameters were measured.
Pharmacokinetics and pharmacodynamics were determined using
non-compartmental methods and comparisons of Cmax and AUC were
calculated using a standard bio-equivalence approach.
The study found that mean anti-Xa activity,
activated prothrombin time (aPTT), Thrombin time (TT)
concentrations were comparable across all timepoints at baseline,
and throughout the study. The concentration-time profiles for iron
and TSAT were the same between the FPC/UFH admixture and FPC/UFH
administered by separate routes. FPC and UFH were well tolerated
with no reported adverse events.
FPC is FDA-approved in the United States for the replacement of
iron to maintain hemoglobin in adult patients with HDD-CKD. FPC may
be administered in the dialysate or as a slow continuous IV
infusion over three to four hours via the pre dialyzer infusion
line, via the post-dialyzer infusion line, or via a separate
connection to the venous blood line during hemodialysis. In vitro
drug-drug interaction studies have demonstrated that FPC can be
admixed with unfractionated heparin and retain its pharmacodynamic
effect for up to 24 hours.
About Triferic Dialysate and Triferic AVNU
Triferic Dialysate (ferric pyrophosphate citrate) and Triferic
AVNU (ferric pyrophosphate citrate injection) are the only
FDA-approved therapies in the U.S. indicated to replace iron and
maintain hemoglobin in hemodialysis patients during each dialysis
treatment. Triferic Dialysate and Triferic AVNU have a unique and
differentiated mechanism of action, which has the potential to
benefit patients and health care economics. Triferic Dialysate and
Triferic AVNU represent a potential innovative medical advancement
in hemodialysis patient iron management – with the potential to
become the future standard of care.
Triferic Dialysate and Triferic AVNU both deliver approximately
5-7 mg iron with every hemodialysis treatment to replace the
ongoing losses to maintain hemoglobin without increasing iron
stores. Both formulations donate iron immediately and completely to
transferrin (carrier of iron in the body), which is then
transported to the bone marrow to be incorporated into hemoglobin.
Because of this unique mechanism of action, there is no increase in
ferritin (a measure of stored iron). Triferic and Triferic AVNU
address a significant medical need in treating functional iron
deficiency in end-stage kidney disease patients.
The safety profile of Triferic is similar to placebo in
controlled clinical trials in patients with end-stage kidney
disease. Since approval, there have been no safety related changes
to the product labeling.
IMPORTANT SAFETY INFORMATION FOR TRIFERIC AND TRIFERIC
AVNU
INDICATION
TRIFERIC and TRIFERIC AVNU are indicated for the replacement of
iron to maintain hemoglobin in adult patients with
hemodialysis-dependent chronic kidney disease (HDD-CKD).
Limitations of Use
TRIFERIC and TRIFERIC AVNU are not intended for use in patients
receiving peritoneal dialysis. TRIFERIC and TRIFERIC AVNU have not
been studied in patients receiving home hemodialysis.
Warnings and Precautions
Serious hypersensitivity reactions, including anaphylactic-type
reactions, some of which have been life-threatening and fatal, have
been reported in patients receiving parenteral iron products.
Patients may present with shock, clinically significant
hypotension, loss of consciousness, and/or collapse. Monitor
patients for signs and symptoms of hypersensitivity during and
after hemodialysis until clinically stable. Personnel and therapies
should be immediately available for the treatment of serious
hypersensitivity reactions. Hypersensitivity reactions have been
reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two
randomized clinical trials.
Iron status should be determined on pre-dialysis blood samples.
Post-dialysis serum iron parameters may overestimate serum iron and
transferrin saturation.
Adverse ReactionsMost common adverse reactions (incidence ≥3%
and at least 1% greater than placebo) in controlled clinical
studies include: headache, peripheral edema, asthenia, AV fistula
thrombosis, urinary tract infection, AV fistula site hemorrhage,
pyrexia, fatigue, procedural hypotension, muscle spasms, pain in
extremity, back pain, and dyspnea.
About Rockwell Medical
Rockwell Medical is a commercial-stage biopharmaceutical company
developing and commercializing its next-generation parenteral iron
technology platform, Ferric Pyrophosphate Citrate (FPC), which has
the potential to lead transformative treatments for iron deficiency
in multiple disease states, reduce healthcare costs and improve
patients’ lives. The Company has two FDA-approved therapies
indicated for patients undergoing hemodialysis, which are the first
two products developed from the FPC platform. Rockwell Medical is
also advancing its FPC platform by developing FPC for the treatment
of iron deficiency anemia in patients outside of dialysis, who are
receiving intravenous medications in the home infusion setting. In
addition, Rockwell Medical is one of two major suppliers of
life-saving hemodialysis concentrate products to kidney dialysis
clinics in the United States. For more information, visit
www.RockwellMed.com.
Rockwell Medical Forward-Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws. Words such as, “may,” “might,” “will,” “should,”
“believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,”
“can,” “would,” “develop,” “plan,” “potential,” “predict,”
“forecast,” “project,” “intend” or the negative of these terms, and
similar expressions, or statements regarding intent, belief, or
current expectations, are forward looking statements, including
statements relating to the potential benefits of Triferic. 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, but are not limited to: the impact of the COVID-19
pandemic on Rockwell’s business, including any clinical trials, and
the FDA’s response time, the risks of current treatment patterns in
the home infusion setting for iron deficiency anemia and whether
the FDA will raise any issues with the IND during its review
period; and those risks more fully discussed in the “Risk Factors”
section of our Quarterly Report on Form 10-Q for the period ended
September 30, 2021 and of our Annual Report on Form 10-K for the
year ended December 31, 2020, as such description may be amended or
updated in any future reports we file with the SEC. Rockwell
Medical expressly disclaims any obligation to update our
forward-looking statements, except as may be required by law.
ROCKWELL MEDICAL CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Apr 2023 to Apr 2024