BioCentury
ARTICLE | Product Development

BTKs for MS: Phase II win for Roche as Sanofi falters in Phase III

Data from tolebrutinib, fenebrutinib to be presented at ECTRIMS this month

September 4, 2024 9:32 PM UTC

While Sanofi became the latest company to see a BTK inhibitor fail in Phase III for relapsing multiple sclerosis, Roche reported new Phase II data that it believes bode well for bucking the trend when its Phase III trials read out next year.

On Tuesday, Sanofi (Euronext:SAN; NASDAQ:SNY) announced that oral BTK inhibitor tolebrutinib missed the primary endpoint of improvement in annualized relapse rate (ARR) versus its marketed therapy Aubagio teriflunomide in the Phase III GEMINI 1 and 2 studies in relapsing multiple sclerosis (RMS). The result marks the second Phase III miss in the past year for a BTK inhibitor to treat RMS, after Merck KGaA (Xetra:MRK) announced in December that first-in-class evobrutinib missed the same endpoint against the same active comparator in the Phase III evolutionRMS 1 and 2 trials...

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