Phase III trials to start in Novartis/Genmab multiple sclerosis collaboration

pharmafile | June 2, 2016 | News story | Research and Development Arzerra, Genmab, Novartis, multiple sclerosis, ofatumumab, phase III 

Genmab (NASDAQ: GEN) has announced that its collaboration partner, Novartis, is set to initiate Phase III trials for ofatumumab in the treatment of multiple sclerosis.

The drug, marketed under the name Arzerra under a collaboration agreement between Novartis and Genmab, is approved for the treatment of chronic lymphocytic leukaemia. It is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes.

Ofatumumab was being trialled in other indications, but with mixed results. Genmab terminated a Phase III trial for the drug in relapsed follicular non-Hodgkin’s lymphoma after it was found unlikely to show superiority to Roche’s MabThera (rituximab). It also discontinued late-stage trials for the drug in autoimmune conditions last March.

The Phase III trial is expected to begin enrolling multiple sclerosis patients in September 2016. It is expected that approximately 900 patients will participate in the study. The primary endpoint will be annualised relapse rate (ARR), which is the number of confirmed relapses in a 12 month period.

Jan van de Winkel, CEO at Genmab, says: “Ofatumumab has the potential to be a best-in-class anti B-cell therapy for relapsing MS. We look forward to swift execution and outcome of these trials and to further development of ofatumumab in this disease area.”

Sean Murray

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