Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) 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 assess the efficacy of frexalimab in delaying disability progression and its safety over a 36-month period in adults with nonrelapsing secondary progressive multiple sclerosis (nrSPMS).
The intervention being tested is frexalimab, administered intravenously, alongside MRI contrast-enhancing agents. Frexalimab is an experimental drug intended to treat nrSPMS by potentially slowing down the progression of the disease.
This study is designed as a randomized, double-blind, placebo-controlled trial with a parallel group model. It involves quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are all unaware of the group assignments. The primary purpose of the study is treatment-focused.
The study began on December 27, 2023, with an estimated completion timeline of 43 months from the randomization of the first participant. The primary completion date is yet to be determined, and the last update was submitted on July 1, 2025.
The outcome of this study could significantly impact Sanofi’s stock performance and investor sentiment, particularly if frexalimab proves effective. This would position Sanofi competitively within the pharmaceutical industry, especially in the treatment of multiple sclerosis, a field with ongoing research and development by various companies.
The study is currently ongoing, with further details available on the ClinicalTrials portal.