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Sanofi’s Promising Phase 3 Study on Frexalimab for Multiple Sclerosis: A Potential Game Changer

Sanofi’s Promising Phase 3 Study on Frexalimab for Multiple Sclerosis: A Potential Game Changer

Sanofi SA ((SNY)), Sanofi ((SNYNF)), Sanofi ((DE:SNW)) announced an update on their ongoing clinical study.

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Sanofi is conducting a Phase 3 clinical study titled ‘A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis.’ The study aims to evaluate the efficacy of frexalimab in delaying disability progression in adults with nonrelapsing secondary progressive multiple sclerosis (nrSPMS), highlighting its potential significance in treating this condition.

The intervention being tested is frexalimab, administered intravenously, alongside MRI contrast-enhancing agents. Frexalimab is designed to slow down the progression of disability in nrSPMS patients.

This interventional study is randomized and follows a parallel assignment model with quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are blinded. The primary purpose is treatment-focused.

The study began on December 27, 2023, with an expected duration of 43 months, concluding when a target number of 6-month confirmed disability progression events is reached. The last update was submitted on July 14, 2025.

This study could influence Sanofi’s stock performance positively if successful, as it addresses a significant unmet need in the treatment of nrSPMS. Competitors in the multiple sclerosis treatment market may also be impacted as new data emerges.

The study is ongoing, and further details are available on the ClinicalTrials portal.

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