Novartis’ Phase III studies of ofatumumab achieve primary goals

16th September 2019 (Last Updated December 23rd, 2019 09:26)

Novartis has reported positive findings from the Phase III ASCLEPIOS I and II clinical trials of ofatumumab (OMB157), which met their primary endpoints in relapsing forms of multiple sclerosis (RMS) patients.

Novartis’ Phase III studies of ofatumumab achieve primary goals
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Novartis has reported positive findings from the Phase III ASCLEPIOS I and II clinical trials of ofatumumab (OMB157), which met their primary endpoints in relapsing forms of multiple sclerosis (RMS) patients.

Ofatumumab is an anti-CD20 monoclonal antibody (mAb) designed to cause B-cell lysis and depletion. It has been formulated for once-monthly, subcutaneous self-administration.

The identical design, double-blind, randomised, multi-centre ASCLEPIOS I and II studies compared the safety and efficacy of 20mg ofatumumab monthly injections with a 14mg once-daily dose of Sanofi’s Aubagio oral tablets.

The trials were performed in 1,882 patients at 350 sites across 37 countries.

ASCLEPIOS I and II met the primary endpoint of demonstrating a significant and clinically meaningful decrease in the annualised relapse rate (ARR), which was measured as the number of confirmed relapses.

Ofatumumab led to a 50.5% and 58.8% ARR reduction in ASCLEPIOS I and II, respectively.

Patients treated with Novartis’ drug also experienced significant suppression of Gd+ T1 lesions and T2 lesions versus Aubagio.

Pooled analyses revealed a 34.4% and 32.5% relative risk reduction in three-month and six-month confirmed disability progression, respectively, with ofatumumab.

Novartis added that the safety profile of its drug in these Phase III trials is similar to the Phase II data. The company is planning to file regulatory submissions by the end of this year.

Novartis global drug development head and chief medical officer John Tsai said: “Ofatumumab showed high efficacy and a favourable 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.”

This announcement comes after Janssen Pharmaceutical’s positive data from a Phase III trial comparing its ponesimod to Sanofi’s Aubagio in MS patients.