A formulation of ofatumumab (brand name Arzerra) to be injected under the skin (subcutaneous) was found to be safe and effective in the treatment of relapsing-remitting multiple sclerosis (RRMS), even when given at lower doses compared with Arzerra, which is administered intravenously, according to the results of a Phase 2 trial.
Besides offering the possibility of self-administration by the patient, treatment with subcutaneous ofatumumab was seen to effectively reduce the number of brain lesions without leading to severe depletion of immune B-cells, one of the consequences of treatment with intravenous Arzerra.
The study reporting the findings is titled “Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis — The MIRROR study,” and was published in the journal Neurology.
Ofatumumab is a human monoclonal antibody targeting the CD20 molecule, which is found on the surface of B-cells or lymphocytes — key cells of the immune system also implicated in the development of multiple sclerosis.
Arzerra is currently the only approved ofatumumab formulation, indicated for the treatment of chronic lymphocytic leukemia (CLL), a blood cancer that typically develops in B-cells.
By targeting CD20, ofatumumab is able to direct the body’s immune system to fight both normal and cancerous B-cells. The medication is marketed and developed by the Danish biotech company Genmab, under a development and commercialization agreement with Novartis.
The new subcutaneous formulation of ofatumumab showed promising effects in the treatment of RRMS in preclinical studies of animal models.
That, together with positive safety and toxicity data obtained in Phase 1 trials, prompted the launching of a larger Phase 2 study, called MIRROR (NCT01457924), to evaluate the effectiveness and safety of subcutaneous ofatumumab for the treatment of people with RRMS.
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