Genmab A/S announces that its collaboration partner Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrolment of patients expected to start in September 2016.
The studies will compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS. Details of the studies will shortly become available on clinicaltrials.gov.
“Ofatumumab has the potential to be a best-in-class anti B-cell therapy for relapsing MS,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to swift execution and outcome of these trials and to further development of ofatumumab in this disease area.”
The Phase III trials are randomized, double-blind, double-dummy studies comparing the efficacy and safety of subcutaneous ofatumumab versus teriflunomide, a standard treatment in MS, in approximately 900 patients with relapsing MS per study. Patients will be randomized to receive either subcutaneous injections of ofatumumab every four weeks or of teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo). The primary endpoint of the studies is annualized relapse rate (ARR), which is the number of confirmed relapses in a 12 month period. The studies will be conducted by Novartis.