On September 13, Novartis announced the positive results of the Phase III ASCLEPIOS I and ASCLEPIOS II studies at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
The ASCLEPIOS I and ASCLEPIOS II studies employed identical randomized, double-blind, multicenter designs with different treatment durations (up to 30 months) to evaluate the differences in safety and efficacy between monthly subcutaneous injections of 20 mg ofatumumab and once-daily oral Aubagio (teriflunomide) in 1,882 adult patients aged 18–55 years with relapsing multiple sclerosis.
Data show that both the ASCLEPIOS I and ASCLEPIOS II studies met their primary endpoints. Ofatumumab demonstrated a clinically meaningful significant improvement in reducing the number of relapses, defined as the annualized relapse rate (ARR). In the two studies, the ARR for ofatumumab was 0.11 and 0.10, respectively, compared with 0.22 and 0.25 for teriflunomide, representing a reduction in ARR of 50.5% and 58.8%, respectively, with ofatumumab versus teriflunomide.
Furthermore, MRI assessment results demonstrated that ofatumumab significantly suppressed gadolinium-enhancing T1 lesions and new or enlarging T2 lesions compared with teriflunomide, suggesting more sustained anti-inflammatory activity. According to established pooled analysis results, ofatumumab reduced the risk of 3-month confirmed disability progression by 34.4% and the risk of 6-month confirmed disability progression by 32.5%.
In terms of safety, ofatumumab was consistent with previous Phase II data. Novartis plans to submit a marketing application to regulatory authorities by the end of 2019 for ofatumumab in the treatment of multiple sclerosis. Ofatumumab is a humanized monoclonal antibody targeting the CD20 antigen on the surface of B cells. It was first approved by the FDA on October 26, 2009, for the treatment of chronic lymphocytic leukemia.