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

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

Sanofi is conducting a clinical study titled ‘Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis.’ The study aims to assess the annualized relapse rate (ARR) in patients with relapsing forms of multiple sclerosis, comparing the effects of Frexalimab against Teriflunomide. This research is significant as it could offer new insights into effective treatments for this chronic condition.

The study tests Frexalimab, an experimental drug administered via infusion, and compares it to Teriflunomide, an established oral medication. Frexalimab is intended to reduce relapse rates in multiple sclerosis patients, potentially offering a new therapeutic option.

This interventional study employs a randomized, parallel assignment model with quadruple masking (participant, care provider, investigator, outcomes assessor) to ensure unbiased results. The primary purpose is treatment-focused, aiming to determine the efficacy and safety of the interventions.

The study began on December 13, 2023, with an estimated completion timeline of approximately 40 months for the first participant and 20 months for the last. The most recent update was submitted on July 22, 2025, indicating ongoing progress.

The outcome of this study could significantly impact Sanofi’s stock performance by potentially introducing a new treatment for multiple sclerosis, enhancing its market position. Investors should monitor this development, as positive results could shift market dynamics and influence competitor strategies.

The study is currently recruiting, with further details available on the ClinicalTrials portal.