Roche's Fenebrutinib Shows Promising Phase III Results for Multiple Sclerosis
- Fenebrutinib significantly reduced relapses in RMS compared to teriflunomide over 96 weeks.
- In PPMS, fenebrutinib was non-inferior to OCREVUS in delaying disability progression over 120 weeks.
- Full data from both studies will be shared at upcoming medical meetings, with regulatory submission expected after FENhance 1 results in 2026.
- Fenebrutinib targets B cells and microglia, addressing both acute inflammation and chronic damage.
Phase III Study Results
Roche's fenebrutinib has shown promising results in Phase III trials for multiple sclerosis. In the FENhance 2 study, fenebrutinib significantly reduced the annualized relapse rate in relapsing multiple sclerosis (RMS) compared to teriflunomide over 96 weeks. In the FENtrepid study for primary progressive multiple sclerosis (PPMS), fenebrutinib was non-inferior to OCREVUS in delaying disability progression over 120 weeks.
Future Data and Submission Plans
Full data from both studies will be presented at upcoming medical meetings. The results from the second RMS study, FENhance 1, are expected in the first half of 2026. Once available, all data will be considered for submission to regulatory authorities.
Mechanism of Action
Fenebrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor targeting B cells and microglia. This dual targeting helps control acute inflammation and addresses chronic damage, potentially reducing both disease activity and disability progression in multiple sclerosis.
Study Design
The FENhance 1 and 2 studies are multicenter, randomized, double-blind trials comparing fenebrutinib with teriflunomide in 1,497 RMS patients. The FENtrepid study involves 985 PPMS patients, comparing fenebrutinib with OCREVUS. Both studies include an open-label extension phase where all patients can receive fenebrutinib.
Source: Roche