Roche's BTK inhibitor shines in multiple sclerosis trial - Clinical Trials Arena
Roche's Phase II study of BTK inhibitor fenebrutinib shows 96% of RMS patients relapse-free at one year, with no disability change and 99% free of T1-Gd+ lesions. The safety profile remains consistent, with ongoing Phase III trials expected to validate these results.
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Fenebrutinib, Roche’s BTK inhibitor, effectively suppressed disease activity and halted disability progression in RMS patients for up to 48 weeks, with 96% experiencing no relapses and 99% free of T1-Gd+ lesions. The drug's safety profile remained consistent, with mild AEs reported.
Roche's Phase II study of BTK inhibitor fenebrutinib shows 96% of RMS patients relapse-free at one year, with no disability change and 99% free of T1-Gd+ lesions. The safety profile remains consistent, with ongoing Phase III trials expected to validate these results.
Roche's fenebrutinib achieved a mid-stage win in RMS, showing near-total elimination of disease activity, while Sanofi's tolebrutinib had mixed results, missing primary endpoints in two Phase III studies but succeeding in a third, delaying disability progression in progressive MS. Both drugs face safety concerns, particularly liver injury, which will be a key focus at upcoming presentations. Despite mixed results, tolebrutinib is expected to generate $2.6 billion in sales by 2030, while fenebrutinib is projected to reach $810 million.