Sanofi SA
reported Wednesday new data from a Phase 2 study in relapsing multiple sclerosis.
What Happened: The company’s CD40L antibody, frexalimab, demonstrated sustained reduction of disease activity. It also demonstrated favorable tolerability after nearly one year in participants with relapsing multiple sclerosis.
"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," said Patrick Vermersch.
Results of the phase 2 OLE at week 48 showed:
- 96% of patients who continued receiving high-dose frexalimab. Eighty-seven percent of those who continued receiving low-dose frexalimab were free of Gd+ T1 lesions at week 48, respectively.
- Additionally, among patients who switched from placebo to high and low-dose frexalimab at the start of the open-label extension (OLE) at week 12, declines were seen at Week 24, and 90% and 92% were free of Gd+ T1 lesions at week 48, respectively.
- The number of Gd+ T1-lesions (mean [SD]) remained low in participants who continued receiving frexalimab (high dose: 0.0 [0.2]; low dose: 0.2 [0.5]) and continued to decline in those who switched from placebo to frexalimab at week 12 (high dose: 0.2 [0.6]; low dose: 0.1 [0.3]).
- The number and volume change of new or enlarging Gd+ T2-lesions remained low through week 48.
- Lymphocyte counts remained stable.
- Participants who continued receiving high-dose frexalimab experienced a low annualized relapse rate (ARR) of 0.04 over the 48-week treatment period. Up to 96% were free of relapses.
- ARR in the initial low-dose arm was 0.22, and ARR in patients who switched to high and low-dose frexalimab were 0.09 and 0.40, respectively, through week 48.
- Frexalimab was generally well-tolerated through week 48.
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