Phase III clinical trial program initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS)
Phase IIIb clinical trial program of higher-dose Ocrevus to evaluate impact on reducing disability progression in RMS and PPMS
Ocrevus CHIMES study exclusively focused on disease insights and more tailored care for minority populations with MS
South San Francisco, CA — September 8, 2020 —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today 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 Latinx-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.
“We remain committed to advancing the science in MS by investigating potential new medicines such as fenebrutinib, with the ultimate goal of halting progression of this disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “In addition, over 170,000 people have been treated with Ocrevus, our first-in-class B-cell therapy, and we are incorporating years of clinical trial data and real-world evidence to optimize its potential to improve outcomes for patients with MS.”
Fenebrutinib Phase III clinical trial programGenentech 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.