Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi SA is conducting a 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 effectiveness of Frexalimab in delaying disability progression in adults with nonrelapsing secondary progressive multiple sclerosis (nrSPMS) and assess its safety over a 36-month period. This research is significant as it targets a challenging phase of multiple sclerosis with limited treatment options.
The intervention being tested is Frexalimab, administered intravenously. It is designed to slow down the progression of disability in nrSPMS patients. The study also includes a placebo group for comparison.
The study follows a randomized, double-blind, placebo-controlled, parallel-group design. It involves quadruple masking, meaning that the participants, care providers, investigators, and outcomes assessors are all unaware of the group allocations. The primary purpose is treatment-focused.
The study began on December 27, 2023, and is currently recruiting participants. It is expected to last for 43 months, with the primary completion date yet to be determined. The last update was submitted on July 29, 2025, indicating ongoing progress.
The successful development of Frexalimab could positively impact Sanofi’s stock performance by enhancing its portfolio in the multiple sclerosis market, potentially increasing investor interest. As competition in the pharmaceutical industry remains fierce, advancements in treatment options for nrSPMS could provide Sanofi with a competitive edge.
The study is ongoing, with further details available on the ClinicalTrials portal.