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167 Fenebrutinib maintains low disease activity in relapsing multiple sclerosis: results from the FENopta open-label extension
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167 Fenebrutinib maintains low disease activity in relapsing multiple sclerosis: results from the FENopta open-label extension
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Journal Article
167 Fenebrutinib maintains low disease activity in relapsing multiple sclerosis: results from the FENopta open-label extension
2025
Overview
BackgroundFenebrutinib is a potent, highly selective, noncovalent, reversible Bruton’s tyrosine kinase inhibitor. In the Phase II FENopta study (NCT05119569), participants received Fenebrutinib 200mg orally BID or placebo. Fenebrutinib reduced inflammatory disease activity in RMS and demonstrated CNS penetrance during the 12-week double blind treatment period. Here we present open label extension study results through Week 48, during which all participants received Fenebrutinib 200 mg BID.Results99 participants enrolled in the OLE; and 96 (97%) remain. At OLE week 48, 96% of participants were relapse free (ARR 0.04) and mean T1 Gd+ lesions were 0.015 lesions per scan (n=67), with 99% of participants free of T1Gd+ lesions. T2 lesion volume decreased in both groups during the OLE.Median EDSS change from baseline was 0 for each arm.The most common AEs were UTI (8%), COVID-19 (7%) and pharyngitis (5%). Serious AEs occurred in one participant (1%) as did asymptomatic ALT elevation (1%), which resolved with treatment discontinuation.Conclusions1 year of fenebrutinib treatment resulted in low ARR, stable EDSS and low MRI activity in participants with RMS, with a favourable safety profile. Ongoing Phase III trials will better characterise the effects of fenebrutinib on disease progression across MS phenotypes.sophie.wrigley@roche.com
Publisher
BMJ Publishing Group LTD
Subject
