Phase III ASCLEPIOS trials yield positive results for Novartis

Novartis has reported positive results of the Phase III ASCLEPIOS I and II studies which involved 1,882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale score between 0 and 5.5. Data from both studies show ofatumumab (OMB157) was superior to Aubagio (teriflunomide) in patients with relapsing forms of MS. Additional secondary endpoints included confirmed disability improvement at 6 months, serum levels of neurofilament light chain, and rate of brain volume loss.
Novartis’ John Tsai, Head of Global Drug Development and CMO, said: “Ofatumumab showed high efficacy and a favorable safety profile in people with RMS, offering a potential first B-cell therapy that can be self-administered in the home. This is a big step forward in our relentless efforts to advance and reimagine treatment in the MS journey of each patient.”
Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences, said: “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. 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.”