Ofatumumab demonstrates superiority versus Aubagio in two head-to-head Phase III multiple sclerosis studies

Novartis announced positive results for ofatumumab (OMB 157) 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.

About ASCLEPIOS: The ASCLEPIOS I and II studies (NCT02792218 and NCT02792231) are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase III studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus Aubagio 14mg oral tablets taken once daily in adults with a confirmed diagnosis of RMS. The 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. The studies were conducted in over 350 sites in 37 countries. The primary endpoint of both studies was to demonstrate that ofatumumab is superior to Aubagio in reducing the frequency of confirmed relapses as evaluated by the ARR in patients treated up to 30 months. Secondary endpoints included time to disability progression confirmed at three and six months respectively, confirmed disability improvement at 6 months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions, serum levels of neurofilament light chain (NfL), and rate of brain volume loss. Safety and the pharmacokinetic properties of ofatumumab were also measured throughout the treatment period.