- Roche (RHHBY, Financial) reports promising 96-week data on fenebrutinib for relapsing multiple sclerosis, showing no disability progression.
- The Phase II study recorded an annualized relapse rate of 0.06, equivalent to one relapse every 17 years.
- The safety profile was consistent with previous data, with common adverse events including COVID-19 and urinary tract infection.
Roche (RHHBY) announced new 96-week data from the Phase II FENopta open-label extension study, revealing that fenebrutinib demonstrated sustained efficacy in treating relapsing multiple sclerosis (RMS). Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, showcased no disability progression and low levels of disease activity for up to two years.
The study noted an impressive annualized relapse rate of 0.06, which equates to approximately one relapse every 17 years. Additionally, the study reported zero new T1 gadolinium-enhancing lesions after 96 weeks, indicating robust suppression of disease activity in the brain. Ninety-nine patients initially entered the extension study, and 93 remained active participants by the 96-week mark.
In terms of safety, the profile of fenebrutinib aligned with prior data, with common adverse events such as COVID-19 and urinary tract infections recorded in 10% of participants each. Two patients experienced serious adverse events, and one patient discontinued treatment due to elevated liver enzymes. Currently, three Phase III trials are in progress, with initial outcomes anticipated by the end of 2025.
Fenebrutinib remains the only reversible BTK inhibitor undergoing Phase III evaluation in multiple sclerosis, potentially addressing the significant unmet need for reducing disability progression in individuals with the condition.
