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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.