Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 84

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 84
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 3 studies for the treatment of MS (see details in “— c ) Neurology ”) below, and in Phase 2 studies for the treatment of systemic lupus erythematosus and adults and adolescents with newly diagnosed type 1 diabetes. In 2024, the clinical development of frexalimab in Sjogren’s syndrome was discontinued based on results from the Phase 2 study; the data confirmed pharmacological activity and a well-tolerated safety profile, but not the necessary efficacy outcomes to continue to move the development forward in this indication. balinatunfib ( SAR441566 ) the first small molecule TNFR1 signaling inhibitor, is intended to provide patients with an oral alternative to anti-TNFa monoclonal antibodies in the range of inflammatory indications where these have been approved. Balinatunfib is a ‘pipeline-in-a-product’ asset currently being evaluated in two Phase 2b clinical studies for the treatment of psoriasis and RA, respectively. In these two indications, results are expected in the first and second half of 2025, respectively. In 2024, a Phase 2 study was initiated to assess balinatunfib in adults with moderate-to-severe Crohn’s disease. itepekimab (SAR440340) is a human anti-IL33 monoclonal antibody co-developed with Regeneron. A Phase 3 clinical program is evaluating itepekimab for the treatment of COPD in former smokers (AERIFY-1 and AERIFY-2 studies) and in current smokers (AERIFY-2); results are expected in the second half of 2025. In addition, an exploratory Phase 2a study (AERIFY-3) is evaluating the mechanism of action of itepekimab and its impact on airway inflammation in former and current smokers with COPD. Itepekimab has FDA fast-track designation for the treatment of COPD. In 2024, an additional Phase 2 study evaluating itepekimab for the treatment of patients with bronchiectasis was initiated. rilzabrutinib (SAR444671) is a covalent and reversible inhibitor of Bruton’s tyrosine kinase under evaluation in multiple clinical studies across a range of autoimmune/inflammatory indications. Positive results were obtained in 2024 from the RILECSU Phase 2 study, showing that rilzabrutinib significantly improved itch,