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The results of the study confirm the results of the previous population PK study, demonstrating safe and effective anticoagulation and delivery of ferric pyrophosphate ferric citrate
Wixom, Michigan, November 16, 2021 (Global News Agency)-Rockwell Medical Corporation (NASDAQ: RMTI) is a biopharmaceutical company dedicated to changing iron deficiency and anemia To improve the treatment of patients around the world, today announced the results of a study published in the Journal of Bioequivalence and Bioavailability. The study aims to investigate intravenous (IV) ferric pyrophosphate citrate (FPC, Triferic® and unfractionated heparin (UFH) are passed through the HD-machine syringe pump as a mixture. The study shows that there is no clinically relevant drug interaction between FPC and UFH that affects UFH, nor does it affect the ability of FPC to provide bioavailable iron when these drugs are co-administered as a single mixture through the HD machine syringe pump.
"These findings are significant because they prove that there is no clinically relevant drug interaction between FPC and unfractionated heparin, which has long been the standard for anticoagulation for hemodialysis patients," Rockwell Chief Medical Officer Marc Hoffman Medical The doctor said medical. "In addition, the results of the study confirm the results of the previous study, which uses a population pharmacokinetic model of anti-Xa activity to confirm the effective anticoagulant dose of UFH, and is consistent with our FPC clinical experience in the real environment, which has been safe More than 160,000 doses were administered."
The prospective, single-center, open-label, three-phase, crossover trial aims to study the ability of the FPC/UFH mixture to maintain adequate anticoagulation in the dialyzer circuit, and to evaluate the effect of the mixture administration on iron in hemodialysis-dependent chronic kidney disease (HDD- CKD) Patient's FPC delivery. The study investigated three treatment options in a random order. The anti-Xa activity, activated prothrombin time (aPTT), thrombin time (TT) and serum iron parameters were measured. Use non-compartmental methods to determine pharmacokinetics and pharmacodynamics, and use standard bioequivalence methods to calculate the comparison of Cmax and AUC.
The study found that the average anti-Xa activity, activated prothrombin time (aPTT), and thrombin time (TT) concentrations were comparable at baseline and at all time points throughout the study. The concentration-time curve of iron and TSAT is the same between FPC/UFH mixture and FPC/UFH administered by different routes. FPC and UFH were well tolerated, and no adverse events were reported.
FPC is approved by the FDA in the United States to replace iron to maintain hemoglobin in adult patients with HDD-CKD. FPC can be administered in the dialysate, or through the pre-dialysis infusion line, the post-dialysis infusion line, or through a separate connection with the venous blood line during hemodialysis, in a slow continuous intravenous infusion within three to four hours. In vitro drug-drug interaction studies have shown that FPC can be mixed with unfractionated heparin and maintain its efficacy for up to 24 hours.
About Triferic Dialysate and Triferic AVNU
Triferic Dialysate (ferric citrate pyrophosphate) and Triferic AVNU (ferric citrate pyrophosphate injection) are the only FDA-approved therapies in the United States to replace iron in hemodialysis patients and maintain hemoglobin during each dialysis treatment. Triferic Dialysate and Triferic AVNU have unique and differentiated mechanisms of action, which may benefit patients and healthcare economically. Triferic Dialysate and Triferic AVNU represent potentially innovative medical advances in iron management for hemodialysis patients-with the potential to become the standard of care in the future.
Both Triferic Dialysate and Triferic AVNU provide approximately 5-7 mg of iron per hemodialysis treatment to make up for continuous loss to maintain hemoglobin without increasing iron reserves. Both formulas immediately donate the iron completely to transferrin (the carrier of iron in the body), and then transport it to the bone marrow to bind to hemoglobin. Due to this unique mechanism of action, ferritin (a measure of stored iron) will not increase. Triferic and Triferic AVNU address the major medical needs for the treatment of functional iron deficiency in patients with end-stage renal disease.
In controlled clinical trials in patients with end-stage renal disease, the safety of Triferic is similar to that of placebo. Since approval, there have been no safety-related changes to product labels.
Important safety information for TRIFERIC and TRIFERIC AVNU
TRIFERIC and TRIFERIC AVNU are suitable for replacing iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
TRIFERIC and TRIFERIC AVNU are not suitable for patients on peritoneal dialysis. TRIFERIC and TRIFERIC AVNU have not been studied in patients receiving home hemodialysis.
According to reports, patients receiving parenteral iron products have severe hypersensitivity reactions, including allergic reactions, some of which have been life-threatening and fatal. Patients may experience shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for allergy symptoms and signs during and after hemodialysis until clinically stable. Personnel and therapy should be provided immediately to treat severe hypersensitivity reactions. In two randomized clinical trials, 1 out of 292 patients treated with TRIFERIC (0.3%) reported a hypersensitivity reaction.
The iron status should be determined based on blood samples taken before dialysis. Serum iron parameters after dialysis may overestimate serum iron and transferrin saturation.
Adverse reactions The most common adverse reactions in controlled clinical studies (incidence ≥3% and at least 1% higher than placebo) include: headache, peripheral edema, fatigue, AV fistula thrombosis, urinary tract infection, AV fistula site bleeding, fever , Fatigue, programmed hypotension, muscle cramps, limb pain, back pain, and breathing difficulties.
Rockwell Medical is a commercial-stage biopharmaceutical company that is developing and commercializing its next-generation iron technology platform for injection, ferric citrate pyrophosphate (FPC), which has the potential to lead a transformative treatment of iron deficiency in a variety of disease states. Reduce medical costs and improve patients’ lives. The company has two FDA-approved therapies for patients undergoing hemodialysis. These 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 receive intravenous drugs in a home infusion environment. In addition, Rockwell Medical is one of the two major suppliers of life-saving hemodialysis concentrate products for kidney dialysis clinics in the United States. For more information, please visit www.RockwellMed.com.
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may", "may", "will", "should", "believe", "expect", "anticipate", "estimate", "continue", "may", "may", "will", etc. , "Development", "plan", "potential", "forecast", "forecast", "project", "intention" or the negative words of these terms, and similar expressions or statements about intentions, beliefs or current expectations, yes Forward-looking statements, including statements related to Triferic's potential interests. Although Rockwell Medical believes that these forward-looking statements are reasonable, it should not place undue reliance on any such forward-looking statements, which are based on information available to us on the date of this press release. These forward-looking statements are based on current estimates and assumptions and are subject to various risks and uncertainties (including but not limited to the risks and uncertainties specified in Rockwell Medical’s SEC documents), many of which exceed Within our control and may change. Actual results may be very 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), as well as the FDA’s response time, the risks of current treatment models in the iron-deficiency anemia family infusion environment, and whether the FDA will Raise any questions to the IND during its review; these risks are in our quarterly report on Form 10-Q for the period ended September 30, 2021 and our annual report on Form 10-K for the year ended December 31, 2020. The “Risk Factors” section is discussed more fully, and such descriptions may be revised or updated in any future reports we submit to the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, unless required by law.
Investor: Argot Partners 212.600.1902 Rockwell@argotpartners.com
Media: David Rosen Argot Partners 212.600.1902 david.rosen@argotpartners.com
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