Genentech/Roche initiates phase III trial programme for fenebrutinib in multiple sclerosis.

Genentech, a member of the Roche Group announced the initiation of an innovative Phase III clinical trial program for its investigational medicine fenebrutinib in multiple sclerosis (MS), along with a higher-dose Phase III clinical trial program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with MS . Overviews of clinical trials and scientific rationale will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from September 11-13, 2020. Genentech is initiating a Phase III clinical trial program for fenebrutinib, an investigational oral Bruton’s tyrosine kinase (BTK) inhibitor in relapsing MS (RMS) and primary progressive MS (PPMS). Increasing evidence suggests that B cells and myeloid lineage cells contribute to disease progression in MS. Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell activation, which may conceivably offer a novel approach to suppress disease activity and slow disease progression by targeting both acute and chronic inflammatory aspects of MS, which will be studied in the Phase III clinical trial program. Pre-clinical data have shown fenebrutinib is highly selective and acts as a non-covalent agent with a slow release rate from its target. The Phase III clinical trial program includes two identical Phase III trials in RMS (named FENhance 1 and FENhance 2) and one Phase III trial in PPMS (named FENtrepid) . All three trials are targeting clinical disability progression and have a primary endpoint of 12-week composite confirmed disability progression (cCDP-12), with the addition of a co-primary endpoint of annualized relapse rate in the RMS trials. The PPMS study is the first study in this patient population to have an active comparator – Ocrevus – rather than placebo.