▎WuXiEdited by Kant Content Team

Today, Sanofi announced that the positive results from the Phase 2 trial of its potential "best-in-class" monoclonal antibody frexalimab for the treatment of multiple sclerosis (MS) have been published in The New England Journal of Medicine. The study showed that frexalimab significantly slowed disease activity in patients with relapsing MS.Sanofi has launched a Phase 3 clinical trial for frexalimab in the treatment of relapsing MS and non-relapsing secondary progressive MS.

The results published in The New England Journal of Medicine were derived from a phase 2 clinical trial, in which 129 adults with relapsing multiple sclerosis were randomly assigned to receive one of two doses of frexalimab (high dose [n=52] and low dose [n=51]) or a matched placebo (high dose [n=12] and low dose [n=14]; data pooled for efficacy analysis). In the high-dose treatment group, participants received intravenous injections of 1200 mg frexalimab every 4 weeks. In the low-dose treatment group, participants received subcutaneous injections of 300 mg frexalimab every 2 weeks. The analysis results after 12 weeks of treatment are as follows:

• Both doses of frexalimab significantly reduced the number of new GdE T1 hyperintense MRI brain lesions in patients.Compared with placebo, the ratios of new GdE T1 lesion counts in patients receiving higher and lower doses of frexalimab were 0.11 (95% CI: 0.03–0.38) and 0.21 (95% CI: 0.08–0.56), respectively, indicating that higher and lower doses of frexalimab reduced new GdE T1 lesion counts by 89% and 79%, achieving the primary endpoint of the trial.

• Both doses of frexalimab significantly reduced the number of new/enlarged T2 lesions in patients. Compared with placebo, the ratios of GdE T2 lesion counts in the higher and lower dose frexalimab groups were 0.08 (95% CI: 0.03-0.26) and 0.14 (95% CI: 0.05-0.41), respectively, indicating that the higher and lower doses of frexalimab decreased the number of newly emerging GdE T2 lesions by 92% and 86%, respectively, achieving the secondary endpoint of the trial.

  
  

  

  
  

• Both doses of frexalimab significantly reduced the total number of GdE T1 lesions in patients. Compared with placebo, the ratios of the total number of GdE T1 lesions in patients receiving the higher and lower doses of frexalimab were 0.12 (95% CI: 0.04-0.36) and 0.20 (95% CI: 0.07-0.53), respectively, indicating that the higher and lower doses of frexalimab reduced the total number of GdE T1 lesions by 88% and 80%, respectively, achieving another secondary endpoint of the trial.

• Frexalimab was well tolerated, with 125 (97%) participants completing part A of the trial and proceeding to the open-label part B.

Frexalimab (SAR441344) is a novel monoclonal antibody believed to block the co-stimulatory CD40/CD40L cellular pathway, which is essential for the activation and function of both adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cells., without the need for lymphocyte depletion.

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