MS Breakthrough? Fenebrutinib Stuns Disease Progression for Two Years!

Harper ClarkMay 30, 2025
An artistic rendering of a neuron being powerfully shielded from the damaging effects of MS, with a bright, hopeful light emanating from the protected cell, symbolizing renewed health and control over the disease.
  • Disease Standstill: Astonishing new data reveals fenebrutinib maintained near-complete suppression of MS activity for an incredible two years5, 7.
  • Disability Defied: Patients with relapsing MS experienced NO disability progression while on the investigational drug for up to 96 weeks.
  • A New Dawn for MS? This unique, reversible BTK inhibitor in Phase III trials offers a powerful new hope against the relentless march of multiple sclerosis4, 6.

In a stunning development that could reshape the future of multiple sclerosis treatment, Genentech's investigational drug, fenebrutinib, has demonstrated an extraordinary ability to hold the line against this debilitating disease. New 96-week data from the Phase II FENopta open-label extension study shows that patients with relapsing multiple sclerosis (RMS) not only maintained near-complete suppression of disease activity but also, crucially, showed no disability progression for up to two years5, 7.

The results, presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, paint a picture of profound impact: an annualized relapse rate so low it equates to just one relapse every 17 years. Furthermore, MRI scans revealed that fenebrutinib treatment effectively silenced disease activity in the brain, with zero new active inflammatory lesions detected at the 96-week mark1, 2, 5.

Fenebrutinib is not just another hopeful; it's a potent, highly selective, and the only reversible Bruton’s tyrosine kinase (BTK) inhibitor currently in Phase III trials for MS4, 6. Its innovative dual mechanism, targeting both B-cell and microglia activation, is believed to be key to its power in reducing both MS disease activity and disability progression—potentially addressing a critical unmet need for those living with MS6, 8.

With Phase III trial results eagerly anticipated by the end of 2025, the MS community watches with renewed optimism4, 6. Fenebrutinib stands as a beacon, signaling a potential turning point in the long battle against multiple sclerosis.


References

  1. mstrust.org.uk
  2. www.clinicaltrialsarena.com
  3. genentech-clinicaltrials.com
  4. www.gene.com
  5. www.neurology.org
  6. www.labiotech.eu
  7. www.biospace.com
  8. www.roche.com

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