Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi has launched a Phase 2b clinical study titled ‘A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy.’ The study aims to evaluate the safety and efficacy of Frexalimab in preserving pancreatic β-cell function in patients with newly diagnosed Type 1 Diabetes (T1D) who are on insulin therapy.
The intervention being tested is Frexalimab, a CD40L-antagonist monoclonal antibody, administered via intravenous infusion initially and followed by subcutaneous injections. It is designed to preserve endogenous insulin secretion in T1D patients.
This interventional study employs a randomized, parallel assignment model with triple masking (participant, care provider, investigator) to ensure unbiased results. The primary purpose is treatment-focused, aiming to assess the potential of Frexalimab in improving patient outcomes.
The study began on December 11, 2023, with primary completion anticipated within 52 weeks, followed by a blinded extension of another 52 weeks. The last update was submitted on July 16, 2025, indicating ongoing recruitment and data collection.
The outcome of this study could significantly impact Sanofi’s market position, potentially boosting investor confidence and stock performance if results are favorable. This study places Sanofi in a competitive position within the diabetes treatment market, where advancements are closely monitored by investors and industry stakeholders.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.