Roche's Investigational Drug For Relapsing Multiple Sclerosis Reduces Brain Lesions, Data Shows

Roche Holdings AG's  RHHBY Phase 2 FENopta study of oral fenebrutinib for relapsing forms of multiple sclerosis (RMS) met its primary and secondary endpoints.

The data showed oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. 

Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase 3 trials for MS.

Fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared to the placebo, the trial's primary endpoint (p=0.0022). 

Additionally, fenebrutinib significantly reduced the number of new or enlarging T2 brain lesions compared to placebo, a secondary endpoint. 

Furthermore, more patients treated with fenebrutinib were free from new gadolinium-enhancing T1 brain lesions and new or enlarging T2-weighted brain lesions compared to placebo. 

T1 lesions are a marker of active inflammation, and T2 lesions represent the disease burden or lesion load.

The Phase 3 fenebrutinib clinical trial program in RMS and primary progressive MS (PPMS) is ongoing.

Competitor Merck KGaA MKGAF said in April that FDA placed a partial clinical hold on initiating new patients on evobrutinib in the Phase 3 EVOLUTION trial for RMS.

Reuters noted that Merck was previously seen to lead the race to win approval in the MS segment.

Sanofi SA SNY encountered similar problems with its drug candidate.