Sanofi’s Frexalimab Shows Promise in Multiple Sclerosis with Positive Phase 2 Results

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Phase 2 Success:
Sanofi's frexalimab, a CD40L monoclonal antibody, has shown significant efficacy in reducing disease activity in patients with relapsing multiple sclerosis (MS) in a Phase 2 trial.

Efficacy Data:
The study demonstrated a significant reduction in new gadolinium-enhancing T1-lesions (a measure of active inflammation) by 89% at the high dose and 79% at the low dose compared to placebo after 12 weeks.

Safety Profile:
The drug was well-tolerated, with the most common adverse events being mild to moderate cases of COVID-19 and headaches. No thromboembolic events were reported, which had been a concern with previous CD40L blockade approaches.

Future Plans:
Sanofi has initiated Phase 3 trials to further assess the efficacy and safety of frexalimab in relapsing MS and non-relapsing secondary progressive MS.

Market Potential:
Sanofi estimates that frexalimab could generate peak annual sales of $5.4 billion or more, reflecting its potential as a high-efficacy treatment option for MS.

Mechanism of Action:
Frexalimab works by blocking CD40L, a signaling protein involved in immune cell activation, without causing lymphocyte depletion, which is a common side effect of other MS therapies.