Press Release

New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis

New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis

• Data support frexalimab as a potential first-in-class, high-efficacy, non-lymphocyte depleting treatment for relapsing multiple sclerosis
• 96% of participants receiving high-dose intravenous frexalimab had no new Gd+ T1 lesions and an annualized relapse rate of 0.04 after 48 weeks
• Sanofi has initiated global phase 3 studies of frexalimab in relapsing MS and non-relapsing secondary progressive MS
  
  

Paris, April 17, 2024. Sanofi’s CD40L antibody, frexalimab, demonstrated sustained reduction of disease activity and favorable tolerability after nearly one year in participants with relapsing multiple sclerosis. These data will be presented today at the American Academy of Neurology (AAN) 2024 Annual Meeting in Denver, Colorado, US. Results from the 12-week double-blind study period were previously published in The New England Journal of Medicine.

Patrick Vermersch, MD, PhD
University of Lille, CHU Lille, France
“These 48-week data showed that treatment with frexalimab resulted in further decreases in the number of lesions and a sustained reduction in disease activity. The preliminary clinical results are promising with a very low annual relapse rate. This strengthens the rationale for targeting CD40L in MS and supports further development of frexalimab as a potential high-efficacy therapy in relapsing MS.”

From the initial 12-week double-blind period, 97% (125/129) of study participants entered the open-label extension (OLE) of the phase 2 study. Of all participants receiving frexalimab, both on high- and low-dose regimens and participants who switched from placebo at the start of the open-label extension period (week 12), 87% (112/129) remained in the study at the 48-week cut-off. During the OLE, participants in the high- (n=50) and low-dose (n=49) arms continued to receive frexalimab 1200 mg intravenously every four weeks, or frexalimab 300 mg subcutaneously every two weeks, respectively, while those initially receiving placebo switched to the aforementioned high or low dose frexalimab treatment arms (n=12 and n=14, respectively).