Rozrolimupab is a recombinant antibody mixture, specifically containing 25 Rhesus D, or

RhD Rh blood group, D antigen also known as Rh polypeptide 1 (RhPI) or cluster of differentiation 240D (CD240D) is a protein that in humans is encoded by the ''RHD'' gene. The RHD gene codes for the RhD erythrocyte membrane protein that is the Rh fa ...

, human antibodies, and is currently under development by

Symphogen Symphogen is a biotechnology company located in Copenhagen, Denmark that develops protein drugs based on recombinant monoclonal antibody mixtures. These drugs are different from the polyclonal antibody, polyclonal antibodies, as each antibody in the ...

for the treatment of immune thrombocytopenic purpura (ITP) and for the prevention of hemolytic disease of the newborn (HDN).

Clinical trials

Phase two trials have proved to be promising. Utilizing a single

intravenous Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutrie ...

infusion dosing, this phase was held in 41 centers across the United States, Europe, and Asia in order to evaluate an effective dose. The 61 patient study was assessing rozrolimupab's ability to effectively treat ITP and HDN as well as how safe and tolerable the drug is. Common adverse effects included mild to moderate headache, pyrexia, chills, and fatique. The study showed that administration of the drug did effect platelet responses in the blood, with a median time of response of roughly two and a half days, and on average lasting a total of 14 days.

Current ITP and HDN treatment

While the current blood-derived treatment has proved successful, its dependence on a donor population proves problematic. Rozrolimupab's manufactured antibody mixture may be an alternative.

References

Polyclonal antibodies {{blood-drug-stub