Novartis has reported that the Phase III ASCLEPIOS I and II clinical trials of ofatumumab (OMB157) have met the primary endpoints in adults suffering from relapsing forms of multiple sclerosis (RMS).
The head-to-head studies compared the safety and efficacy of monthly subcutaneous 20mg ofatumumab to once-daily oral 14mg dose of Sanofi’s Aubagio.
Ofatumumab is a fully human monoclonal antibody (mAb) that targets the CD20 molecule present on the B-cell surface. It has been formulated for self-administration by patients at home.
The identical design ASCLEPIOS I and II trials involved a total of 1,882 patients, aged between 18 and 55 years, at more than 350 sites across 37 countries.
The primary endpoint was the superiority of ofatumumab over Aubagio in decreasing the frequency of confirmed relapses in participants treated up to 30 months.
The trials’ secondary endpoints included time to disability progression at three and six months, disability improvement at six months, the number of new or enlarging T2 lesions, gadolinium-enhancing T1 lesions, levels of neurofilament light chain (NfL) in serum and rate of brain volume loss.
Ofatumumab met the primary endpoint in both studies with a significant and clinically meaningful decrease in the confirmed relapses. Furthermore, the studies showed delayed time to confirmed disability progression.
The safety profile of Novartis’ drug was found to be consistent with its Phase II data.
Novartis chief medical officer and global drug development head John Tsai said: “Ofatumumab, if approved, could be a highly attractive treatment option for a broad RMS patient population, including early MS. The powerful study results are a reflection of our commitment to reimagine MS treatment at all stages of the disease.”
The company intends to file applications seeking regulatory approvals for ofatumumab by the end of the year.
If approved, the drug will expand Novartis’ multiple sclerosis portfolio, which includes Gilenya (fingolimod), Mayzent (siponimod) and Extavia.