Rockwell Medical Presents Triferic® Real World Evidence Update at ASN Kidney Week 2021
05 November 2021 - 7:01AM
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 presented new Real World Evidence from a Mid-Sized
Dialysis Organization (MDO) pilot observational analysis program at
the American Society of Nephrology (ASN) Kidney Week 2021 in San
Diego, California. Results indicated that Triferic (Ferric
Pyrophosphate Citrate, FPC) is well-tolerated for the replacement
of iron to maintain hemoglobin in adult patients with
hemodialysis-dependent chronic kidney disease (HDD-CKD), findings
which are consistent with prior Real World Evidence of Triferic and
pivotal clinical trials. The abstract can be viewed online here.
“This new Real World Evidence confirms findings from our prior
Real World Evidence publications and from our pivotal clinic
trials, namely, that the integration of Triferic into anemia
management protocols results in the reduction of IV iron and ESA
use, and potentially to a significant reduction in overall cost of
treatment,” said Marc Hoffman, M.D., Chief Medical Officer at
Rockwell Medical. “Today’s results are relevant not only for
patients and caregivers but for dialysis clinics and the medical
community, and further strengthen Triferic’s position as an
important part of the treatment arsenal for patients on
hemodialysis.”
In the study, Triferic was added to centrally delivered liquid
bicarbonate to provide 110 µg Fe/L dialysate, and all patients
received Triferic at each dialysis appointment. Anonymized
prospective data were provided between September 2020 and April
2021. During the first three months of administration of Triferic,
clinics in the study observed a modest 23 percent reduction of IV
iron. Subsequently, a new iron management protocol was released
specifically designed to guide IV iron use in conjunction with
Triferic; this was adopted by nine clinics while five clinics chose
to maintain their standard of care. Within three months of
initiation of the new protocol, iron utilization in the Triferic
group decreased by 81 percent, while iron utilization increased by
19 percent in the standard of care group. During this same period,
hemoglobin remained stable in both groups (+/- 0.2 g/dL from
baseline). Concurrent with these changes, Mircera® (methoxy
polyethylene glycol-epoetin beta) dose remained stable in the
standard of care group but was reduced 37 percent (from
post-adoption baseline) in the Triferic group.
Additional clinics continued to adopt the new protocol over
time. Taking into account the staggered adoption of the protocol,
after eight months, the aggregate iron utilization across all 14
clinics was reduced by 51 percent and trending lower. Mircera dose
was stable (decreased 5 percent) and hemoglobin remained
stable.
For more information about real-world evidence related to
Triferic or to directly access the publications, please visit
www.triferic.com/resources.
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. The Company is
developing FPC for the treatment of iron deficiency in patients
outside of dialysis, who are receiving intravenous medications in
the home infusion setting, a large and rapidly growing segment of
healthcare, and where these patients suffer from chronic diseases
associated with high incidence of iron deficiency and anemia. 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.
CONTACTSInvestors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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