Genmab to Begin Phase 3 Trials of Ofatumumab to Treat Relapsing Multiple Sclerosis

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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MS clinical trials

GenmabĀ announced plans to soon begin a Phase 3Ā clinical trial program assessing the subcutaneous formulation of ofatumumabĀ as a potential treatment forĀ relapsing multiple sclerosis (MS). The company, workingĀ in collaboration with its partnerĀ Novartis, will begin enrolling patients in September in trials that willĀ evaluate the efficacy and safety of ofatumumab compared toĀ teriflunomide (Aubagio), an approved relapsing MS treatment.

Ofatumumab is a human monoclonal antibody targeting an epitope in the CD20 molecule, which isĀ found on the surface of B-cells, important immune cells thatĀ are involved in the pathogenesis of MS and also cancer. By targeting CD20, ofatumumab is able to direct the body’s immune system to fight normal and cancerous B-cells.

The Phase 3 trials (ASCLEPIOS I and II studies)Ā are randomized, double-blind studies to compare the safety and efficacy of ofatumumab versus teriflunomide, in approximately 900 patients with relapsing MS inĀ eachĀ study. Patients will be randomized to receive either subcutaneous injections of ofatumumab every four weeks, or teriflunomide orally once daily. The trials’ primary endpoint is theĀ annualized relapse rate (ARR), meaningĀ the number of confirmed relapses in a 12-month period. Novartis will be conducting the studies.

ā€œOfatumumab has the potential to be a best-in-class anti B-cell therapy for relapsing MS,ā€ Jan van de Winkel, PhD, chief executive officer of Genmab, said in aĀ press release. ā€œWe look forward to swift execution and outcome of these trials and to further development of ofatumumab in this disease area.ā€

A Phase 2Ā clinical trial for relapsing-remitting MS (RRMS) investigating the subcutaneous formulation of ofatumumab has been completed, and top-line results demonstrated significant reduction in the cumulative number of new brain lesions, according to a Genmab statement.

Ofatumumab, under the trade name Arzerra, is currently approved in the United States, in combination with chlorambucil, for the treatment ofĀ previously untreated patients withĀ chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

More information on the plannedĀ Phase 3Ā studies is expected to beĀ available soon.

MS is aĀ demyelinating diseaseĀ of unknown etiology in which theĀ insulating covers (myelin) ofĀ nerve cellsĀ in theĀ brainĀ andĀ spinal cordĀ are damaged.Ā This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range ofĀ signsĀ andĀ symptoms, including physical,Ā mental, and sometimes psychiatric problems.

MS affects approximately 2.5 million people worldwide. The most common form of MS, accounting for 80% of the cases,Ā is RRMS, which is characterized by unpredictable recurrent attacks where the symptoms usually evolve over days and are followed by either complete, partial or no neurological recovery. No progression of neurological impairment is experienced between attacks.