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

Shots:

• 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

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