Novartis Phase III ASCLEPIOS trials demonstrate robust efficacy of ofatumumab in patients with relapsing multiple sclerosis
Both ASCLEPIOS I and II studies met their primary endpoints in patients with relapsing forms of MS (RMS) ; overall ofatumumab (OMB157), a subcutaneous, potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favorable safety profile. RMS patients on ofatumumab had a reduction in annualized relapse rate (ARR) by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25) compared to Aubagio * (teriflunomide) (both studies p<0.001) in ASCLEPIOS I and II studies respectively - Ofatumumab showed highly significant suppression of gadolinium (Gd) T1 lesions when compared to Aubagio , demonstrating a profound suppression of new inflammatory activity - Ofatumumab showed a relative risk reduction of 34.4% in 3-month confirmed disability progression (CDP+) (p=0.002) and 32.5% in 6-month CDP (p=0.012) versus Aubagio in pre-specified pooled analyses - Ofatumumab, if approved, will potentially become a treatment for a broad RMS population and the first B-cell therapy that is easy to start and manage in a monthly self-administered injection at home Basel, September 13, 2019 - Novartis, a global leader in neuroscience, today presented positive results of the Phase III ASCLEPIOS I and II studies at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden.
