Roche Holdings AG (OTC:RHHBY) on Friday announced new 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low disease activity levels for up to two years.
The latest results for this investigational Bruton’s tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.
Ninety-nine patients entered the OLE and 93 remained in the OLE after 96 weeks.
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During the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualised relapse rate (ARR) of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale (EDSS).
MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, were detected.
In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualized rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12-week double-blind period to 0.34 by 96 weeks.
The safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks.
During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation.
Three Phase 3 trials are ongoing, including the FENhance 1 and 2 trials in RMS and the FENtrepid trial in primary progressive multiple sclerosis (PPMS). The first data from these studies are expected at the end of 2025.
In April, Roche announced it would invest $50 billion in the U.S. over the next five years.
These investments further strengthen Roche’s already significant U.S. footprint, which includes 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions.
The investment is expected to create over 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities.
Price Action: RHHBY stock is trading higher by 1.83% to $40.25 at last check Friday.
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