Key Takeaways
Genentech, a member of the Roche Group (RHHBY), announced Tuesday that its investigational oral drug fenebrutinib cut the annualized relapse rate for relapsing multiple sclerosis (RMS) by 51.1% in a late-stage study.
The positive data came from the Phase III FENhance 1 and 2 studies, which met their primary endpoint. "The studies showed that fenebrutinib, an investigational non-covalent Bruton's tyrosine kinase (BTK) inhibitor, reduced the annualized relapse rate," the company said in a statement, a result that translates to approximately one relapse every 17 years for patients.
Fenebrutinib is the only non-covalent BTK inhibitor currently in Phase III trials for MS. The drug's mechanism is designed to block the function of BTK, a protein involved in the immune responses that drive nerve damage in patients with multiple sclerosis.
The successful trial results are a significant step toward regulatory approval, positioning fenebrutinib as a potential major new revenue source for Roche. The positive outcome could intensify competition for other major players in the multiple sclerosis drug market, such as Novartis and Sanofi. Genentech plans to submit the data to regulatory authorities globally.
This article is for informational purposes only and does not constitute investment advice.
