• Head to head Phase III ASCLEPIOS studies I & II of OMB157 (ofatumumab) have revealed considerable superiority in reducing the ARR (annualized relapsed rate) in patients suffering from RMS (relapsing forms of multiple sclerosis) in comparison with terinuflomide.
• OMB157 also met the secondary key endpoints of delaying time to confirmed progression of disability.
• Ofatumumab safety profile was in keeping with the Phase II results, delivering sustained effectiveness.

Danish biotechnology expert Genmab A/S has reportedly announced Novartis’ positive results for OMB157 (ofatumumab) observed from the ASCLEPIOS I & II studies in Phase III. The studies, conducted to test the effectiveness and safety of monthly ofatumumab 20g (administered subcutaneously) vs once-daily teriflunomide 14g (administered orally) in adult patients with relapsing multiple sclerosis forms (RMS), showed that both treatments met primary endpoints, with ofatumumab showing profound and clinically significant reduction in confirmed relapse numbers, assessed as the ARR.

Key secondary endpoints for delay in time to confirm disability progression were met as well.

According to Genmab CEO, Jan van de Winkel, PhD, the information gathered through these studies indicates a potential turning point for ofatumumab and reinforces the belief that, if approved, it could become the 1^st subcutaneously administered B-cell therapy for RMS, which patients can self-administer. He further expressed Genmab’s anticipation for the authorities’ feedback and delight for this new stage in the development of ofatumumab.

Novartis, that carries the right to develop and market of atumumab licensed by Genmab, has started plans to begin submissions to health authorities by the end of the year, on the basis of data collected during the ASCLEPIOS studies.

Phase III ASCLEPIOS I & II study results will be presented on the 13^th of September in a late-breaker presentation format, at the esteemed 35^th Congress of the ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis). The event is expected to take place from 11^th to 13^th September 2019, in Stockholm.

Source Credit: https://www.globenewswire.com/news-release/2019/08/30/1908824/0/en/Ofatumumab-Demonstrates-Superiority-Versus-Teriflunomide-in-Two-Head-to-Head-Phase-III-Multiple-Sclerosis-Studies.html