Roche’s MS Drug Hits Phase II Mark, Rivals Remain Under Clinical Holds
BIOMARKER
1. Roche's subsidiary Genentech announced that its candidate, fenebrutinib, met the endpoints in a Phase II trial for multiple sclerosis (MS) by significantly reducing brain lesions in patients with relapsing forms of the disease.
2. The study compared the number of new T1 and new or enlarging T2 brain lesions using MRI scans and found positive results for fenebrutinib.
3. No new safety concerns were identified in the top-line data of the Phase II study.
4. Fenebrutinib will continue to Phase III studies in patients with primary progressive MS and relapsing MS.
5. The market for disease-modifying therapies in MS is estimated to reach $30 billion by the end of the decade.
6. Four Bruton's tyrosine kinase (BTK) inhibitors are currently in Phase III for MS, with Sanofi's tolebrutinib expected to lead the sales forecast at $2.6 billion.
7. However, tolebrutinib, orelabrutinib, and evobrutinib are currently under FDA clinical holds due to safety concerns related to liver injury.
8. Roche's fenebrutinib is the only reversible BTK inhibitor among the contenders, potentially giving it a competitive advantage.
9. Roche's already approved MS treatment, Ocrevus, generated $6.6 billion in sales last year, but its patent is expected to expire in the coming years.
10. The approval of fenebrutinib could help Roche maintain its presence in the MS market and offset potential sales drop-offs from Ocrevus patent expiration.