Roche’s oral drug fenebrutinib showed positive results in treating both primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in its phase 3 trial, FENhance 2.
Fenebrutinib is an investigational Bruton’s tyrosine kinase (BTK) inhibitor with high potency, selectivity, and reversibility. It targets both B cells to control acute inflammation that leads to relapses and microglia to prevent chronic damage in the brain that appears to be responsible for long-term disability progression.
The drug significantly reduced the annualized relapse rate (ARR) in patients with RMS compared to teriflunomide. The results of the study also showed that fenebrutinib is non-inferior compared to Roche's Ocrevus (ocrelizumab), the only approved therapy for PPMS. Patients on the drug experienced a delay in the onset of composite confirmed disability progression throughout the observation period.
FENhance 2 is one of two phase 3 clinical trials. The other, FENhance 1, has a similar design and is also an RMS study. The data for this trial will be released in the first half of 2026, when Roche will consider it for submission to regulatory authorities along with the data from FENhance 2.