Reduce the annual recurrence rate of multiple sclerosis by 50% Novartis CD20 antibodies to reach the clinical end of Phase 3.

MS is a chronic disease of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerve and spinal cord through inflammation and tissue damage.
progression of MS leads to increased loss of physical function (e.g. walking) and cognitive function (e.g. memory).
there are three main types of relapsed relapsed MS (RRMS), secondary progress MS (SPMS), and primary progress MS (PPMS).
RMS is characterized by a well-defined recurrence and remission process, i.e. recurrence, seizure or deterioration, followed by a partial or full recovery period.
, there are about 2.3 million MS patients worldwide, and about 85% of MS patients are initially diagnosed with RMS.
Ofatumab is a fully humanized CD20 antibody.
by binding to CD20 on the surface of B lymphocytes, it is able to remove B cells from the blood that play an important role in stimulating autoimmune responses in MS patients.
the treatment allows patients to be injected once a month at home through subskin injections.
not only provides a convenient way to control the disease, but also can better target B cells in the lymph nodes, reducing the damage to B cells in the spleen.
previously, ofatumab had been approved by the FDA as a leukemia treatment.
the FDA accepted a supplementary biologics licensing application (sBLA) in February and is expected to respond in September.
ASCLEPIOS I and II were two phase 3 clinical trials of the same randomized double-blind, active control group.
results showed that the annual recurrence rate (ARR) of MS was reduced by 51% and 58% respectively in the two trials compared to the active control group.
the critical secondary endpoint of delaying disease progression was also met, with MS confirming a 34 per cent reduction in the risk of disability progression (CDP) after 3 months (p-0.002) and 32 per cent (p-0.01) after 6 months compared to the active control group.
addition, ofatumab's security is consistent with previous Phase 2 study data.
SCLEPIOS study found that ofofatumumab significantly reduced new inflammation and reduced clinical recurrence and progress events," said Professor Stephen L. Hauser, director of the Weill Institute of Neuroscience at the University of California, San Francisco (UCSF) and co-chair of the ASCLEPIOS I and II Research Steering Committee.
it represents a potentially new option for RMS patients, with good efficacy and safety characteristics, and is easy to self-dosing once a month without infusion.
" References: novartis announces NEJM publication of Phase III ASCLEPIOS trials of the production of superior efficacy of of oftumab in patients with relapsing multiple sclerosis. Retrieved August 5, 2020, from.