Roche reported the Phase II FENopta study of fenebrutinib in adult patients with relapsing forms of multiple sclerosis (RMC). The drug met both the primary and secondary endpoints, demonstrating that fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo.
Fenebrutinib is an investigational, potent, and highly selective oral Bruton's tyrosine kinase (BTK) inhibitor.
The Phase II study showed that fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared to the placebo, which was the primary endpoint of the trial. Additionally, fenebrutinib demonstrated a significant reduction in the total number of new or enlarging T2 brain lesions compared to placebo, a secondary endpoint. More patients treated with fenebrutinib were found to be free from any new gadolinium-enhancing T1 brain lesions and new or enlarging T2-weighted brain lesions compared to those on placebo.
The safety profile of fenebrutinib in the FENopta study remained consistent with previous and ongoing clinical trials involving over 2,400 participants to date. No new safety concerns were identified.
Roche's Phase III clinical trial program for fenebrutinib in both RMS and primary progressive MS (PPMS) is currently underway.