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Genmab Has Plans to Begin Phase 3 Trials of Ofatumumab

June 13, 2016

Genmab has announced its plans to soon begin a Phase 3 clinical trial program that assesses the subcutaneous formulation of ofatumumab, which could be a potential treatment for relapsing multiple sclerosis. Collaborating along with their partner Novartis, they will begin enrolling patients into trials this September, where the safety and efficiency of ofatumumab will be evaluated and compared to the approved relapsing MS treatment, teriflunomide (Aubagio).

The human monoclonal antibody, ofatumumab, targets an epitope in the CD20 molecule found on the surface of B-cells. Ofatumumab is able to direct the body’s immune system into fighting normal and cancerous B-cells by targeting CD20.

Each study will have around 900 patients with relapsing MS and will be randomized as well as double-blind studies in order to compare the safety and efficiency in ofatumumab to the currently approved treatment. The patients are chosen at random to be treated with ofatumumab every four weeks or teriflunomide once daily. Novartis will be conducting these studies by using the annualized relapse rate (ARR) which confirms the number of confirmed relapses throughout the year.

After the Phase 2 clinical trials for RRMS investigating ofatumumab was completed, it was demonstrated that there had been significant reduction in the cumulative number of new brain lesions. Ofatumumab, or its trade name Arzerra, is currently approved in the US. It was combined with chlorambucil and used to treat patients with chronic lymphocytic leukemia (CLL) where fludarabine-based therapy is considered inappropriate.

Phase 3 trials are expected to begin soon and there is more information that should be available very soon.