Roche’s Fenebrutinib Shows Promising Results in Relapsing Multiple Sclerosis Phase II Trial

Near-Complete Suppression of Disease Activity:
Roche's investigational BTK inhibitor, fenebrutinib, demonstrated near-complete suppression of disease activity and disability progression in patients with relapsing multiple sclerosis (RMS) in the Phase II FENopta study.

High Efficacy Rates:
96% of patients treated with fenebrutinib were free of relapses at one year, with an annualized relapse rate (ARR) of 0.04. Additionally, 99% of patients were free of T1 gadolinium-enhancing lesions, markers of active inflammation, at 48 weeks.

Safety Profile:
The safety profile of fenebrutinib was consistent with previous and ongoing clinical trials, with the most common side effects being urinary tract infection, COVID-19, and pharyngitis.

Comparison with Sanofi's Tolebrutinib:
Roche's positive results come after Sanofi reported back-to-back late-stage failures for its BTK inhibitor, tolebrutinib, in relapsing MS. However, tolebrutinib showed therapeutic potential in non-relapsing secondary progressive multiple sclerosis (nrSPMS).

Ongoing Phase III Trials:
Roche is conducting Phase III trials (FENhance 1 and 2) for fenebrutinib in relapsing MS and another trial (FENtrepid) in primary progressive MS. These trials are expected to provide further insights into the drug's efficacy and safety.

Potential Impact:
If validated in late-stage studies, fenebrutinib could significantly advance the treatment landscape for multiple sclerosis, addressing a key unmet medical need.