Sanofi reports ‘positive’ results from Phase 2 RILECSU study

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria, or CSU, whose symptoms are not adequately controlled by H1 antihistamines, according to Sanofi. These results were presented today in a late-breaking poster at the 2024 American Academy of Allergy, Asthma and Immunology, or AAAAI, Annual Meeting in Washington, DC and form the basis for the Phase 3 program which is on track to start in 2024. In the intent-to-treat population which included either patients who were previously naive or incomplete responders to omalizumab, Rilzabrutinib 400 mg TID demonstrated: Significant reduction from baseline in weekly itch severity score at Week 12, a key symptom of the disease; Significant changes in ISS7 were seen as early as Week 1. Significant reduction from baseline to week 12 in weekly urticaria activity score; Significant reduction from baseline to week 12 in weekly hives severity score. Rilzabrutinib was generally well-tolerated with no events of cytopenia, bleeding or atrial fibrillation seen with other BTK inhibitor. Naimish Patel, M.D. Head of Global Development, Immunology and Inflammation, Sanofi, said: “These data reinforce the potential of rilzabrutinib as a treatment option for patients with moderate-to-severe CSU and we believe that the rapid improvement of itch could make a meaningful difference in alleviating the physical and psychosocial burden these patients suffer from. Based on these data, later this year we will advance rilzabrutinib into Phase 3 development in both CSU and prurigo nodularis, another skin disorder characterized by relentless itching. We also look forward to data readouts for rilzabrutinib in 2024 with the opportunity to further demonstrate its potential impact across multiple immune-mediated diseases.”