Multiple Sclerosis Society of Canada

Fenebrutinib

Overview:

  • Also known as: GDC-0853, RG7845
  • Pharmaceutical Company: Genentech (subsidiary of Hoffman-La Roche)
  • Route of Administration: Oral
  • Type: Immunomodulator
  • Emerging Treatment for: Relapsing Multiple Sclerosis (RMS); Progressive Multiple Sclerosis 
  • Status: In Phase III clinical trial

How it works

Fenebrutinib selectively inhibits the protein, Bruton’s tyrosine kinase or BTK, in order to reduce the proliferation of B cells that contribute to brain and spinal cord inflammation in MS. Fenebrutinib has also been proposed to prevent the activity of specific immune cells in the brain called microglia, which have been linked to MS progression.

Research and Results

Trials in relapsing MS

Phase III Trial: FENhance

FENhance is a phase III, randomized, double-blind, multi-center clinical trial testing the efficacy and safety of fenebrutinib compared with Aubagio (teriflunomide). The trial is recruiting 734 adults that will be randomly assigned to receive either oral fenebrutinib or oral Aubagio for 96 weeks. The primary outcome measures will evaluate changes in annualized relapse rates and time to confirmed disability progression. The trial will also assess the efficacy of fenebrutinib compared to Aubagio on disability progression and MRI lesions.

Participant recruitment for the FENhance trial is ongoing. The anticipated study completion date is November 2024.

Trials in progressive MS

Phase III Trial: FENtrepid

FENtrepid is a phase III, randomized, double-blind, multi-center clinical trial testing the efficacy and safety of fenebrutinib compared with Ocrevus (ocrelizumab) in people with PPMS. The trial is recruiting 946 adults that will be randomly assigned to receive either daily oral fenebrutinib or intravenous Ocrevus for up to 120 weeks. The primary outcome measures will evaluate the efficacy of fenebrutinib in delaying disability progression in people with PPMS. The trial will also assess the efficacy of fenebrutinib compared to Ocrevus on changes in brain volume and cognitive performance.

Participant recruitment for the FENtrepid trial is ongoing. The anticipated study completion date is May 2028.

References:

Roche. Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab). 2020; retrieved from Roche Press Release.

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