Genmab A/S, an international biotechnology company, announced 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.

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system that affects approximately 2.5 million people worldwide.1 MS is twice as common in females as in males, occurring with a peak incidence at the age of 30 years and incidence varies widely in different populations and ethnic groups. The etiology of MS remains unknown, but the geographic variation points towards possible environmental and genetic factors. Relapsing MS is characterized by unpredictable recurrent attacks and accounts for 80% of MS cases.2

Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes.

Ofatumumab is approved and marketed for intravenous use in certain chronic lymphocytic leukemia indications under the trade name Arzerra.

Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis also has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.

Ofatumumab is not approved anywhere in the world as a treatment for relapsing MS.

Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.