Roche RHHBY recently announced that the late-stage study, FENhance 1, evaluating fenebrutinib for relapsing multiple sclerosis (RMS), met its primary endpoint.
Fenebrutinib is an experimental oral, central nervous system-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimized pharmacokinetic profile.
The fenebrutinib phase III program includes two similarly designed trials in RMS (FENhance 1 and 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against Ocrevus.
More on RHHBY’s FENhance 1 Study Results
FENhance 1 and FENhance 2 are two phase III multicenter, randomized, double-blind, double-dummy, parallel-group studies to evaluate the efficacy and safety of investigational fenebrutinib compared with teriflunomide in a total of 1,497 adult patients with RMS.
Results from the FENhance 1 study showed that fenebrutinib significantly reduced relapses by 51% compared to teriflunomide in RMS, consistent with FENhance 2 results showing 59% reduction.
Secondary endpoints in both RMS studies show statistically significant and clinically meaningful reductions in brain lesions.
FENhance 1 represents the final pivotal readout in the fenebrutinib MS program, following positive results from FENhance 2 in RMS and FENtrepid in primary progressive MS.
Results across all three pivotal studies consistently show that fenebrutinib delivers strong benefits across both relapsing and progressive disease processes.
Safety findings were broadly comparable to teriflunomide, with similar liver enzyme elevations and one Hy’s Law case reported in each treatment arm, both resolving after discontinuation.
The comprehensive data from all three phase III studies will be submitted to regulatory authorities.
Per RHHBY, fenebrutinib could become the first high-efficacy oral therapy that penetrates the brain and treats both RMS and PPMS, with strong effects across relapsing and progressive disease biology.
The successful development of the candidate will boost Roche’s neuroscience portfolio.
Roche’s Ocrevus is approved for RMS and relapsing-remitting MS. The drug is a top-growth driver for the company.
Roche is developing more than a dozen therapies for neurology portfolios, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy.
RHHBY’s Efforts to Broaden Portfolio
Strong growth from key products is helping RHHBY offset revenues from legacy drugs.
The MS drug Ocrevus and the ophthalmology drug Vabysmo continue their stellar performances. Growth in hemophilia treatment Hemlibra and breast cancer drug Phesgo has also boosted RHHBY’s top line.
Vabysmo has given stiff competition to Regeneron’s REGN ophthalmology drug Eylea. Positive data from additional studies bode well for the drug.
Regeneron co-developed Eylea with Bayer.
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities. Positive data on its breast cancer candidate giredestrant and its multiple sclerosis candidate fenebrutinib have increased the likelihood of regulatory approval, which could serve as a meaningful catalyst for the stock.
Novartis’ NVS Kesimpta is indicated for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Kesimpta has put up a strong performance since approval, boosting NVS’ top line. Sales in 2025 came in at $4.4 billion in 2025.
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Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Novartis AG (NVS): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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