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Roche Expands its MS Portfolio with the Initiation of P-III Clinical Program of Fenebrutinib and Ocrevus (ocrelizumab)

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Roche Expands its MS Portfolio with the Initiation of P-III Clinical Program of Fenebrutinib and Ocrevus (ocrelizumab)

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  • Roche has initiated the P-III program for fenebrutinib (BTK inhibitor) in RMS and PPMS which include two identical P-III trials in RMS (FENhance 1& FENhance 2) and one P-III trial in PPMS (named FENtrepid). The studies target clinical disability progression and have a 1EPs of 12wks. cCDP-12- with the addition of a co-primary endpoint of ARR in the RMS studies
  • Roche is initiating two new P-IIIb trials- one in RMS (MUSETTE) and one in PPMS (GAVOTTE)- which will assess a higher OCREVUS dose vs its 600mg dose- with both evaluated at the twice-yearly (six-monthly) dosing schedule
  • Additionally- Roche has initiated P-IV CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) study in African-Americans and Hispanic- and Latinx-Americans with RMS. All the new clinical trials are under progress and anticipated to initiate recruitment in the coming months

­ Ref: Roche | Image: Roche 

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