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 Triferic Phase 3 CRUISE studies (CRUISE 1 and 2) inNephrology Dialysis Transplantation (NDT). Triferic is the only FDA approved iron product indicated for delivery via dialysate to replace iron and maintain hemoglobin in hemodialysis patients in the United States.
Dr. Steven Fishbane, lead author and Chief, Division of Kidney Diseases and Hypertension, North Shore University Hospital and Long Island Jewish Medical Center stated, “I’m very excited to see this Triferic data published. Our study is important and should be of interest to the entire renal community, including patients, because it shows Triferic is an effective iron agent that is able to maintain hemoglobin without inducing iron overload. Triferic is administered at each dialysis session and its iron is immediately donated to transferrin, very similar to the slower natural way iron is used in the body to maintain hemoglobin. Until Triferic, patients undergoing dialysis have been treated almost exclusively with IV iron for their iron replacement, which injects a large amount of iron directly into the blood stream and gets sequestered in the liver resulting in higher and higher ferritins, and which has been associated with a risk of oxidative stress, inflammation, infection, anaphylaxis and tissue iron overload. I believe Triferic is an important new option for iron replacement therapy in patients on chronic hemodialysis.”
Dr. Raymond Pratt, MD FACP, Chief Medical Officer of Rockwell Medical stated, “We are very pleased with the publication of the Phase 3 CRUISE study results in NDT. The study data demonstrates that Triferic is the ideal vehicle to deliver iron and maintain hemoglobin concentration in the HD population, and that it is able to do so without increasing ferritin is a direct result of the iron being immediately utilized for hemoglobin synthesis, avoiding the liver sequestration that occurs with IV iron. Importantly, the safety profile of Triferic, in these two large-scale studies demonstrates a favorable benefit-to-risk ratio for hemodialysis patients.”
“We are thrilled to see the CRUISE study results published in a premier peer-reviewed nephrology journal,” stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell Medical. “Triferic has a unique mode-of-action that enables it to deliver iron immediately and consistently over every patient treatment, without increasing iron stores. As a result, we see Triferic providing optimal patient safety and efficacy benefit as well as significant cost savings in dialysis care. We expect Triferic will become the standard of care for iron delivery for hemodialysis patients in the U.S., and ultimately world-wide.”
The CRUISE studies were randomized, single blind, placebo controlled, efficacy and safety studies in chronic hemodialysis patients. Triferic was added to the bicarbonate hemodialysis concentrate while placebo patients received standard hemodialysate without Triferic. A total of 599 patients participated in both studies with 290 randomized to receive Triferic and 295 to placebo. Patients completed the Phase 3 study when they met pre-specified anemia centered criteria or lasted 48 weeks without achieving the criteria. After completing randomized treatment, patients entered open-label treatment.
The primary objective of the CRUISE studies was to determine whether regular administration of Triferic via dialysate could maintain hemoglobin concentrations by optimizing iron delivery and maintaining iron balance. The primary endpoint was the mean change in hemoglobin from baseline to the end-of-treatment (EoT) defined as the average of all hemoglobin values obtained during the last one-sixth (1/6th) of the time spent in the randomized stage of treatment (Stage 2). Both studies successfully met the primary endpoint with a treatment difference of 0.4 g/dL in hemoglobin concentration in favor of Triferic (P=0.011 for individual studies, 95% confidence interval 0.1 to 0.6 g/dL). During the randomized treatment phase, hemoglobin concentrations remained stable in the Triferic treated group while declined in the placebo group. The safety profile of Triferic was similar to placebo treated patients, with both groups experiencing similar proportions of adverse events. The most frequent adverse event was procedural hypotension which was present in 21.6% of Triferic patients and 19.2% of placebo treated patients. No serious adverse events or deaths were attributed to Triferic. (Original Source)
Shares of Rockwell Medical closed yesterday at $18.02. RMTI has a 1-year high of $18.30 and a 1-year low of $8.10. The stock’s 50-day moving average is $14.19 and its 200-day moving average is $11.45.
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 represents a potential upside of 44.3% from where the stock is currently trading. According to TipRanks.com, Wang has a total average return of 4.2%, a 44.7% success rate, and is ranked #1532 out of 3708 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.