▎Edited by the WuXi AppTec content team
Recently, Sanofi announced positive results from its Phase 2 clinical study RILECSU, with data indicatingRilzabrutinib significantly improved itching, urticaria, and wheal symptoms in adult patients with moderate to severe chronic spontaneous urticaria (CSU) whose symptoms were not adequately controlled by H1 antihistamines.. These results were presented at the 2024 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) and laid the foundation for the Phase 3 clinical research program scheduled to commence in 2024.
In this dose-ranging study, researchers investigated rilzabrutinibDifferent Dosing RegimensThe following doses were evaluated: 400 mg once nightly (QPM); 400 mg twice daily (BID); and 400 mg three times daily (TID). The intent-to-treat population included in this study comprised patients who had previously been non-responders or incomplete responders to omalizumab treatment.After testing, the efficacy of the rilzabrutinib 400 mg TID dosing regimen was confirmed to be effective, with the following results:At Week 12,Weekly Itch Severity Score (ISS7) significantly decreased from baseline (primary endpoint)——This is a major symptom of the disease (Least Squares Mean [LSM] were -9.58 vs -6.31; P=0.0181).Significant changes in ISS7 occurred as early as the first week.From baseline to Week 12, the weekly Urticaria Activity Score (UAS7) significantly decreased.（LSM were -17.95 vs -11.20; p=0.0116).From baseline to week 12, the weekly urticaria severity score (HSS7) significantly decreased.（LSM: -8.31 vs -4.89; p<0.0100).Rilzabrutinib was generally well-tolerated, with no events of cytopenia, bleeding, or atrial fibrillation observed that are typically associated with other Bruton's tyrosine kinase (BTK) inhibitors.Compared with placebo, the treatment-related adverse events that occurred more frequently in the rilzabrutinib group were diarrhea (29.3% TID and BID, 7.9% QPM, 15% placebo), nausea (19.5% TID, 17.1% BID, 13.2% QPM, 5.0% placebo), headache (9.8% TID, 14.6% BID, 5.3% QPM, 0.0% placebo), and abdominal pain (0.0% TID, 12.2% BID, 2.6% QPM, 5.0% placebo).Rilzabrutinib is an oral, reversible, covalent BTK inhibitor,Expected to become a "first-in-class" or "best-in-class" treatment for various immune-mediated diseases. The BTK enzyme is expressed in B cells and mast cells, playing a crucial role in the processes of various immune-mediated diseases. By applying Sanofi's TAILORED COVALENCY technology,Rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of off-target side effects.
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References:
[1] Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria，Retrieved February 26, 2024, from https://www.globenewswire.com/news-release/2024/02/24/2834723/0/en/Press-Release-Phase-2-results-demonstrate-rilzabrutinib-rapidly-reduced-itch-severity-and-significantly-improved-disease-activity-in-adults-with-chronic-spontaneous-urticaria.html
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