Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 85

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 85
---
 hives and urticaria in adults with moderate-to-severe CSU whose symptoms are not adequately controlled by H1-antihistamines; the indication will be further investigated in Phase 3 . Encouraging results from a Phase 2 study showed that treatment with rilzabrutinib at both high and low doses led to a numerical reduction in loss of asthma control events (the primary endpoint) and improvements in symptoms in adults with uncontrolled moderate-to-severe asthma. In the last quarter of 2024, the 52-week open-label two-cohort Phase 2 study of rilzabrutinib in IgG4-related disease showed considerable outcomes on flare-free, steroid-free disease rates. In addition, rilzabrutinib is being evaluated for the treatment of immune thrombocytopenia and warm autoimmune hemolytic anemia (see details in “— b ) Rare diseases ” below ). lunsekimig (SAR443765) is a bispecific NANOBODY ® VHH which blocks both TSLP and IL-13, key upstream and downstream mediators (respectively) of asthma. A Phase 2b study (AIRCULES) is assessing the efficacy, safety, and tolerability of add-on therapy with lunsekimig in adults with moderate-to-severe asthma. In 2024, two additional Phase 2 studies were initiated to assess lunsekimig (i) in adults with asthma who are not eligible for biologic treatments (high-risk asthma), and (ii) in adults with CRSwNP. SAR444656 is a selective, orally administered small molecule targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4), which is necessary for proinflammatory signaling and cytokine production. SAR444656 is developed in partnership with Kymera Therapeutics. Two Phase 2 studies are currently evaluating SAR444656 for the treatment of AD and hidradenitis suppurativa (HS), respectively. duvakitug ( SAR447189 , also known as TEV-48574) is an anti-TL1A monoclonal antibody co-developed with Teva Pharmaceuticals. In 2024, the companies announced that the RELIEVE UCCD Phase 2b study had met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease, the two main types of inflammatory bowel disease (IBD). Sanofi and Teva plan to initiate Phase