April 23, 2024

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Sanofi’s Frexalimab Demonstrates Potential as a Leading Therapy for Multiple Sclerosis

Sanofi’s Frexalimab Demonstrates Potential as a Leading Therapy for Multiple Sclerosis



Sanofi’s Frexalimab Demonstrates Potential as a Leading Therapy for Multiple Sclerosis

Sanofi’s Potential “Best-in-Class” Monoclonal Antibody Reduces Brain Lesions by Nearly 90% According to Publication in The New England Journal of Medicine.

On February 18th, Sanofi announced that the positive results of its phase 2 trial of the potential “best-in-class” monoclonal antibody frexalimab for treating patients with multiple sclerosis (MS) have been published in The New England Journal of Medicine. The study demonstrates that frexalimab significantly slows disease activity in patients with relapsing MS. Sanofi has initiated phase 3 clinical trials of frexalimab for treating relapsing MS and non-relapsing progressive MS.

Sanofi's Frexalimab Demonstrates Potential as a Leading Therapy for Multiple Sclerosis

The results published in The New England Journal of Medicine are from a phase 2 clinical trial that randomly assigned 129 adults with relapsing MS 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, subjects received 1200 mg of frexalimab by intravenous injection every 4 weeks. In the low-dose treatment group, subjects received 300 mg of frexalimab by subcutaneous injection every 2 weeks. The analysis after 12 weeks of treatment showed:

  • Both doses of frexalimab significantly reduced the number of new Gadolinium-enhancing (GdE) T1 magnetic resonance imaging (MRI) brain lesions in patients. Compared to placebo, the ratio of new GdE T1 lesions in the high and low-dose frexalimab groups was 0.11 (95% CI: 0.03-0.38) and 0.21 (95% CI: 0.08-0.56), respectively, meaning that the higher and lower doses of frexalimab reduced the number of new GdE T1 lesions by 89% and 79%, respectively, achieving the primary endpoint of the trial.
  • Both doses of frexalimab significantly reduced the number of new/enlarging T2 lesions in patients. Compared to placebo, the ratio of new GdE T2 lesions in the high and low-dose frexalimab groups was 0.08 (95% CI: 0.03-0.26) and 0.14 (95% CI: 0.05-0.41), respectively, meaning that the higher and lower doses of frexalimab reduced the number of new GdE T2 lesions by 92% and 86%, respectively, achieving a secondary endpoint of the trial.

Both doses of frexalimab significantly reduced the total number of GdE T1 lesions in patients. Compared to placebo, the ratio of total GdE T1 lesions in the high and low-dose frexalimab groups was 0.12 (95% CI: 0.04-0.36) and 0.20 (95% CI: 0.07-0.53), respectively, meaning 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%) subjects completing Part A of the trial and continuing into the open-label Part B.

Frexalimab (SAR441344) is a novel monoclonal antibody believed to block the CD40/CD40L cell pathway necessary for activation and function of adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cells without the need for lymphocyte depletion.

Sanofi’s Frexalimab Demonstrates Potential as a Leading Therapy for Multiple Sclerosis

(source:internet, sanofi, reference only)


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