Novartis, a global leader in neuroscience, announced positive results for ofatumumab (OMB157) from the Phase III ASCLEPIOS I and II studies.
In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio® (teriflunomide) in patients with relapsing forms of multiple sclerosis (RMS). The ASCLEPIOS studies investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once-daily oral Aubagio® 14mg in adults with RMS.
Both studies met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR). Key secondary endpoints of delaying time to confirmed disability progression were also met. The top-line results of the Phase III ASCLEPIOS studies will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place September 11-13, 2019, in Stockholm, Sweden.
Overall ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered sustained efficacy with a favorable safety profile. The safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results. Novartis plans to initiate submissions to health authorities by end of 2019.
“It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is a high 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.
“The results from ASCLEPIOS are wonderful news for patients who would like to take an effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion center.”
“Ofatumumab, if approved, could be a highly attractive treatment option for a broad RMS patient population, including early MS,”
said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis.
“The powerful study results are a reflection of our commitment to reimagine MS treatment at all stages of the disease.”