Danish biotechnology firm Genmab has unveiled positive results from a Phase II study of its sclerosis drug candidate ofatumumab in relapsing-remitting multiple sclerosis (RRMS).
In a randomized study of 232 patients with RRMS, treatment with all doses of ofatumumab compared to subjects treated with placebo over a period of 12 weeks has seen reduction of cumulative number of new active brain lesions.
Britain's GlaxoSmithKline (GSK) has carried out the multi-center, randomized, double-blind, placebo controlled Phase II study in patients with RRMS and there were no unexpected safety findings in the study, according to Genmab.
Main aim of the study was to see whether 3, 30 or 60 mg of ofatumumab given subcutaneously reduces the number of new T1-weighted active brain lesions in RRMS patients.
RRMS is the most common form of multiple sclerosis, which is an inflammatory disease of the central nervous system.
Ofatumumab, which is sold under the name Arzerra, is Genmab's first marketed antibody approved for treatment of chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development.
Arzerra is being developed under a co-development and commercialization agreement between Genmab and GSK.
