Roche's fenebrutinib curbs MS activity, disability for 2 years

Roche's fenebrutinib curbs MS activity, disability for 2 years

By, Admin 2 June 2025

Roche has announced new 96-week data from the open-label extension (OLE) of its phase II FENopta trial, showing that fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, continues to deliver low disease activity and no disability progression in patients with relapsing multiple sclerosis (RMS).

The results were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Phoenix, Arizona.

Key Highlights from the FENopta OLE Study

  • Annualized Relapse Rate (ARR): 0.06 — equivalent to one relapse every 17 years
  • Disability Progression: No progression observed up to 96 weeks, as measured by the Expanded Disability Status Scale (EDSS)
  • MRI Findings:
    • Zero new T1 gadolinium-enhancing (T1-Gd+) lesions at 96 weeks
    • In patients who switched from placebo to fenebrutinib, new/enlarging T2 lesions dropped from 6.72 to 0.34

Strong Safety Profile Sustained Over Time

  • No new safety signals observed at 96 weeks
  • Common adverse events (≥5%):
    • COVID-19 (10%)
    • Urinary tract infections (10%)
    • Pharyngitis (6%)
    • Respiratory tract infections (5%)
  • Serious adverse events: 2 patients (2%)
  • One patient showed elevated liver enzymes, which resolved after treatment discontinuation

Fenebrutinib: A Reversible, Oral BTK Inhibitor

Fenebrutinib is a highly selective, CNS-penetrant BTK inhibitor that targets both:

  • B-cell activation
  • Microglial (innate immune) activation

This dual mechanism could address both disease activity and disability progression, a major unmet need in MS therapy.

Ongoing Phase III Trials in RMS and PPMS

Three global phase III trials are currently evaluating fenebrutinib across the multiple sclerosis spectrum:

  • FENhance 1 & 2 in Relapsing MS (RMS) (vs. teriflunomide)
  • FENtrepid in Primary Progressive MS (PPMS) (vs. Ocrevus)

Data expected by late 2025.

About the Phase II FENopta Study

  • Design: Randomized, double-blind, placebo-controlled
  • Duration: 12 weeks (core), with up to 192-week optional open-label extension
  • Participants: 109 adults aged 18–55 with RMS
  • Endpoints:
    • Primary: New T1-Gd+ lesions on MRI at 4, 8, and 12 weeks
    • Secondary: New/enlarging T2 lesions and lesion-free status
  • Additional insights: Optional cerebrospinal fluid substudy confirmed CNS penetration and reduced neuronal injury biomarkers

Understanding Multiple Sclerosis

  • Affects over 2.9 million people globally
  • Caused by immune-mediated damage to the central nervous system (CNS)
  • Symptoms: Fatigue, weakness, vision issues, and eventual disability
  • Relapsing MS (RMS): ~85% of cases, marked by relapses and gradual progression
  • Primary Progressive MS (PPMS): ~15% of cases, steadily worsening without relapses

Early diagnosis and treatment are critical to limit progression and long-term disability.

Roche’s Commitment to Neuroscience Innovation

Roche is a leader in neuroscience R&D, actively investigating treatments for:

  • Multiple sclerosis
  • Spinal muscular atrophy
  • Neuromyelitis optica spectrum disorder
  • Alzheimer’s, Parkinson’s & Huntington’s disease
  • Duchenne muscular dystrophy

With more than a dozen neuroscience drugs in development, Roche aims to transform the standard of care in chronic neurological conditions.

About Roche

Founded in 1896 in Basel, Switzerland, Roche is the world’s largest biotechnology company and a global leader in in-vitro diagnostics. The company pioneers scientific innovation to deliver life-saving treatments and improve health outcomes worldwide.

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