Rockwell Medical Presents Triferic® Real World Evidence Update at ASN Kidney Week 2021

Rhea-AI Summary

Rockwell Medical presented findings at ASN Kidney Week 2021, highlighting positive results from a pilot observational analysis on Triferic (Ferric Pyrophosphate Citrate) for hemodialysis patients. The study showed a 23% reduction in IV iron usage during the first three months, increasing to 81% reduction with a new iron management protocol. Hemoglobin levels remained stable throughout. These results align with prior pivotal trials and suggest potential cost savings in anemia management for dialysis clinics.

Positive

• 23% reduction in IV iron usage during initial three months.
• 81% reduction in IV iron utilization with new protocol adoption.
• Stable hemoglobin levels maintained throughout the study.
• Supportive findings align with prior trials and Real World Evidence.

Negative

• None.

-Results from pilot observational analysis demonstrate maintenance of hemoglobin and reduction of total IV iron requirement in adult patients on Triferic receiving chronic hemodialysis- 

-Findings align with pivotal trials of Triferic and prior Real World Evidence-

WIXOM, Mich., Nov. 04, 2021 (GLOBE NEWSWIRE) -- 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.

CONTACTS
Investors:
Argot Partners
212.600.1902
Rockwell@argotpartners.com

Media:
David Rosen
Argot Partners
212.600.1902
david.rosen@argotpartners.com 

FAQ

What were the results of Rockwell Medical's pilot analysis on Triferic presented at ASN Kidney Week 2021?

The results indicated a 23% reduction in IV iron usage initially, which increased to 81% with the new management protocol, while hemoglobin levels remained stable.

How does Triferic benefit patients undergoing hemodialysis?

Triferic helps maintain hemoglobin levels and reduces the need for IV iron, potentially lowering overall treatment costs.

What is the significance of the new iron management protocol in the study?

The protocol significantly reduced IV iron usage by 81% in clinics that adopted it, demonstrating a more effective approach to anemia management.

When was the pilot observational analysis conducted?

The analysis provided anonymized data from September 2020 to April 2021.

What are the implications of the study's findings for dialysis clinics?

The findings suggest improved anemia management with reduced treatment costs, which is beneficial for both clinics and patients.