Genentech announced that it will present new data from three Phase 3 clinical trials of its experimental multiple sclerosis (MS) therapy Ocrevus (ocrelizumab) at the 68th annual meeting of the American Academy of Neurology (AAN) being held in Vancouver, Canada, from April 15–21, 2016.
Additionally, results of a new endpoint for the trials — no evidence of disease activity (NEDA) in relapsing MS patients — will be revealed on Wednesday, April 20, at the Clinical Trials Plenary Session. The three trials are Opera I and Opera II, conducted in 1,656 people with relapsing-remitting MS (RRMS), and Oratorio, conducted in 732 people with primary progressive MS.
NEDA, also referred to as freedom from disease activity, is an emerging goal in MS treatment. The aim is to treat people with RRMS with disease modifying drugs (DMDs) until they are found to have reached a point of no relapses, no increase in disability, and no new or active (enhancing) lesions on their magnetic resonance imaging (MRI) scans over a specified period of time.
“The data being presented at AAN show that ocrelizumab significantly reduced disability progression and brain tissue damage in both relapsing and primary progressive forms of MS,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, in a press release. “The analyses demonstrate ocrelizumab’s consistent effect across important measures of disease activity and provide further insights into the clinical effect of ocrelizumab in people with MS.”
More details on presentations being made at the AAN meeting is available on its website.
Genentech is also funding an Industry Therapeutic Update. Fred Lublin, MD, the director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center, will present a study, “Evolving Perspectives on Disease Activity: What Is Lying Beneath the Surface?”, at the Hyatt Regency Ballroom C, on Tuesday, April 19.
MS is a demyelinating disease in which the insulating covers (myelin) of nerve cells in the brain and spinal cord are damaged. This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms.
Ocrelizumab is an investigational humanized anti-CD20 monoclonal antibody, also called a CD20 antagonist. CD20-positive B-cells play a critical role in myelin and axonal damage. Ocrelizumab targets mature B lymphocytes and is an immunosuppressive drug candidate. Ocrelizumab was the first investigational medicine for primary progressive MS to be granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration.