Rockwell Medical Inc (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today the publication of the PRIME study results in Kidney International. Triferic is the only iron product FDA approved for delivery via dialysate to replace iron and maintain hemoglobin in hemodialysis patients in the United States.
Dr. Ajay Gupta, lead author and Chief Scientific Officer of Rockwell Medical stated, “We are very pleased with the publication of this important study inKidney International. The study data demonstrate that Triferic is the perfect iron agent to address the unmet need of treating functional iron deficiency. Its ability to improve ESA responsiveness and reduce ESA requirements highlights its role as the ideal vehicle to deliver iron and maintain hemoglobin, while not increasing ferritin, in the HD population. Importantly, the safety and pharmaco-economic benefits of ESA reduction are realized without the occurrence of oxidative stress or iron sequestration/overload. The PRIME study data provide clear practical guidance for integrating Triferic into the management of anemia in chronic hemodialysis patients.”
“We are extremely pleased to see the PRIME study results published in a premier peer-reviewed nephrology journal,” stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell Medical. “The study data showing Triferic’s ability to reduce ESA use in treating anemia in hemodialysis patients should translate into significant cost savings in dialysis care, while also potentially lowering patient safety concerns associated with the current iron replacement products. Triferic’s benefits, coupled with the high interest level for the drug from dialysis providers, strengthens our belief that Triferic will become the standard of care for iron maintenance therapy treatment in CKD-HD patients.”
The PRIME study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study conducted in the United States to determine the safety and efficacy of Triferic (ferric pyrophosphate citrate) as a treatment to reduce ESA while maintaining hemoglobin. Iron-replete chronic hemodialysis patients were randomized to dialysate containing Triferic-iron versus conventional dialysate. A total of 103 patients received blinded study drug (52 Triferic, 51 Placebo).
The primary objective of the PRIME study was to determine whether regular administration of Triferic via dialysate reduced the need for erythropoiesis stimulating agents (ESA) by optimizing iron delivery and maintaining iron balance. The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period). After adjusting for differences in baseline hemoglobin, the Triferic arm required 35% less ESA dose compared to placebo. The difference between the two groups was statistically significant (p=0.045). The ESA sparing effect from Triferic was observed without an increase in serum ferritin or transferrin saturation above the baseline values. In a pre-specified secondary analysis of the 20% of patients who were hyporesponsive to ESA ( > 13,000 epoetin units/week), the Triferic group used 74.4% (p=NS) less ESA than placebo, further confirming the effect on ESA observed in the entire study cohort. (Original Source)
Shares of Rockwell Medical closed last Friday at $16.97. RMTI has a 1-year high of $18.04 and a 1-year low of $8.10. The stock’s 50-day moving average is $13.97 and its 200-day moving average is $11.33.
On the ratings front, Oppenheimer analyst Ling Wang reiterated a Buy rating on RMTI, with a price target of $26, in a report issued on June 22. The current price target implies an upside of 53.2% from current levels. According to TipRanks.com, Wang has a total average return of 1.7%, a 44.7% success rate, and is ranked #1916 out of 3694 analysts.
Rockwell Medical Inc is a biopharmaceutical company targeting end-stage renal disease and chronic kidney disease with products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.