Rozrolimupab
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Rozrolimupab is a recombinant antibody mixture, specifically containing 25 Rhesus D, or RhD, 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 Immune thrombocytopenic purpura (ITP), also known as idiopathic thrombocytopenic purpura or immune thrombocytopenia, is an autoimmune primary disorder of hemostasis characterized by a low platelet count in the absence of other causes. ITP often ...
(ITP) and for the prevention of
hemolytic disease of the newborn Hemolytic disease of the newborn, also known as hemolytic disease of the fetus and newborn, HDN, HDFN, or erythroblastosis fetalis, is an alloimmune condition that develops in a fetus at or around birth, when the IgG molecules (one of the five ...
(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 nutr ...
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 Fever or pyrexia in humans is a symptom of an anti-infection defense mechanism that appears with body temperature exceeding the normal range caused by an increase in the body's temperature set point in the hypothalamus. There is no single agre ...
, 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