Novartis has announced that its multiple sclerosis (MS) effort, ofatumumab, was able to reduce annualised MS relapse rates (ARR) by 50.5% and 58.5% in the ASCLEPIOS I and II trials respectively, compared to Sanofi's Aubagio (teriflunomide).
The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), showed that both studies met their primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses. The treatment also showed highly significant suppression of both Gd+ T1 lesions and new or enlarging T2 lesions compared to Aubagio.
Further, ofatumumab showed a relative risk reduction of 34.4% in three-month confirmed disability progression (CDP) and 32.5 in six-month CDP versus the Sanofi drug.
The drug, a fully human anti-CD20 monoclonal antibody, is self-administered by a once-monthly subcutaneous injection that is in development for MS and works by binding to the CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion.
“It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is great need for potent, safe, and convenient therapy that can be used to treat MS from the start,” said Professor Stephen L. Hauser, director of the UCSF Weill Institute for Neurosciences.
He continued, “The results from ASCLEPIOS are wonderful news for patients who would like to take an extremely effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion center.”
The ASCLEPIOS I and II studies enrolled 1,882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5.