Novartis’ Ofatumumab Demonstrates Superiority Over Sanofi’s Aubagio in Head-to-Head Phase III Trials for Relapsing Multiple Sclerosis

August 31, 2019 News /BioonBIOON/ -- Swiss pharmaceutical giantNovartis(Novartis) recently announced positive results from two Phase III clinical studies (ASCLEPIOS I, II) of ofatumumab (OMB157) for the treatment of multiple sclerosis.Both studies were head-to-head (H2H) trials conducted in patients with relapsing multiple sclerosis (RMS), evaluating the efficacy and safety of once-monthly subcutaneous injections of 20 mg ofatumumab versus once-daily oral administration of 14 mg Aubagio (teriflunomide).

Aubagio is an oral multiple sclerosis medication from Sanofi. The results showed that both studies met their primary endpoints: when assessed by annualized relapse rate, ofatumumab demonstrated a highly significant and clinically meaningful reduction in the number of confirmed relapses compared with Aubagio. In addition, the studies also achieved the key secondary endpoint of time to confirmed disability progression. Overall, ofatumumab exhibited sustained efficacy and a favorable safety profile. The safety observations for ofatumumab in the two studies were consistent with those from Phase II trials.

Based on the results of these two studies,NovartisThe plan is to initiate the submission of application documents for ofatumumab in the treatment of RMS to regulatory authorities by the end of 2019.Positive topline data from the two ASCLEPIOS studies will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held in Stockholm, Sweden, from September 11–13, 2019.Meetingpublished above.

Professor Stephen L. Hauser, Director of the Weill Institute for Neurosciences at the University of California, San Francisco, stated, “It is clear that early initiation of high-efficacy therapy for multiple sclerosis can improve long-term outcomes, and there is a strong need for potent, safe, and convenient treatment options available from the outset. For patients who desire effective B-cell therapy with lower monitoring requirements and wish to avoid visits to infusion centers, the results from the ASCLEPIOS studies are welcome news.”

NovartisJohn Tsai, Global Drug Development Director and Chief Medical Officer at Novartis, stated: “If approved, ofatumumab could be a highly attractive treatment option for a broad population of patients with relapsing multiple sclerosis (RMS), including those with early-stage disease. These robust study results reflect our commitment to reshaping the treatment landscape for MS across all stages of the disease.”

Ofatumumab is a monoclonal antibody drug targeting CD20, approved for the treatment of chronic lymphocyticLeukemia(CLL), marketed under the brand name Arzerra. ButNovartisOfatumumab has been assigned a new R&D code, OMB157, and is being developed as a next-generation B-cell depleting agent. This drug features more rapid B-cell depletion and potentially favorable safety profiles that preserve immunity, along with the convenience of once-monthly subcutaneous administration. It is poised to challenge Roche’s rapidly growing CD20-targeted therapy, Ocrevus (ocrelizumab), whose sales surged by 172% in 2018 to reach an impressive CHF 2.353 billion.

Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody administered via monthly subcutaneous self-injection. It exerts its therapeutic effect by binding to CD20 molecules on the surface of B cells, thereby inducing effective B-cell lysis and depletion. Positive Phase IIb results for ofatumumab in patients with multiple sclerosis (MS) were announced in 2014, demonstrating a significant reduction in the number of new brain lesions during the first 24 weeks of treatment. In August 2016, Novartis initiated the Phase III clinical program evaluating ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS). In December 2015,NovartisAcquired the rights to ofatumumab for all indications, including multiple sclerosis (MS), from Genmab.

Multiple sclerosis (MS) disrupts the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue damage, affecting approximately 2.3 million people worldwide. The disease is typically classified into three types: relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS, generally defined by the overall accumulation of cognitive and physical changes and disability), and primary progressive multiple sclerosis (PPMS). Approximately 85% of patients initially present with relapsing forms of multiple sclerosis.

Original Source:Novartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studies