Rockwell Medical Inc (NASDAQ: RMTI) stock price surged 82.6% after the publishing of the results of a clinical study to investigate the co-administration of unfractionated heparin (UFH) with intravenous (IV) Ferric Pyrophosphate Citrate (FPC, Triferic) as an admixture via an HD-machine syringe pump.
The results were published in the Journal of Bioequivalence & Bioavailability, where the results did not show any clinically-relevant drug-to-drug interactions.
Investors cheered the news, as evidenced by Rockwell’s premarket rally, as the study results now allow for the two drugs to be administered at the same time since they can work in tandem without either losing their effectiveness.
The study was conducted to determine if the FPC/UFH admixture would maintain adequate anticoagulation of the dialyser circuit and to assess the impact of administration of the admixture on the iron delivery of FPC in patients with Hemodialysis Dependent Chronic Kidney Disease (HDD-CKD).
The study results showed no impairments in each of the two drugs that remained highly effective when the two drugs were administered when mixed using the HD-machine syringe pump.
The study investigated three treatment regimens in a randomised pattern, which measured the activated prothrombin time (aPTT), Anti-Xa activity, Thrombin time (TT), and serum iron parameters.
The pharmacokinetics and pharmacodynamics were measured using non-compartmental methods, while the comparisons of Cmax and AUC were calculated using a standard bio-equivalence approach.
The results showed that activated prothrombin time (aPTT), anti-Xa activity, and Thrombin time (TT) concentrations were comparable across all time points starting from the baseline and throughout the entire study.
Marc Hoffman, M.D., Rockwell Medical’s Chief Medical Officer, said: “These findings are significant because they demonstrated no clinically relevant drug-drug interaction between FPC and unfractionated heparin, the latter of which has long been the standard to provide anticoagulation in patients on hemodialysis. Furthermore, the findings confirm the results of a previous study that used a population pharmacokinetic model for the anti-Xa activity to confirm the effective anti-coagulation dose of UFH and are consistent with our clinical experience of FPC in the real-world setting, in which more than 1.6mm million doses have been safely administered.”
*This is not investment advice. Always do your due diligence before making investment decisions.
Rockwell Medical stock price.
Rockwell Medical stock price surged 82.61% premarket to trade at $0.8787, rising from Tuesday’s closing price of $0.4812.
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