Ofatumumab meets in Phase II RRMS trial

Genmab A/S (CSE:GEN) said all doses of subcutaneous ofatumumab met the primary endpoint in the Phase II MIRROR trial to treat relapsing-remitting multiple sclerosis (RRMS). Ofatumumab led to a 65% reduction in the cumulative number of new T1-weighted gadolinium-enhancing brain lesions as measured by MRI scans over 12 weeks compared to placebo (p<0.001). The double-blind, international trial enrolled 232 patients to receive 3, 30 or 60 mg ofatumumab every 12 weeks; 60 mg ofatumumab every four weeks; or placebo followed by 3 mg ofatumumab at week 12. The treatment period was 24 weeks.

Genmab deferred to partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) on next steps for ofatumumab in the indication. GSK, which has worldwide co-development and commercialization rights to the human mAb against CD20 from Genmab, said it would be unable to respond in time for publication. ...