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Fenebrutinib Reduced Relapses and MRI Disease Activity in Pooled Phase 3 Analysis

A combined analysis of the Phase 3 FENhance 1 and FENhance 2 studies found that fenebrutinib reduced relapses and MRI measures of disease activity compared with teriflunomide in people with relapsing multiple sclerosis.

Fenebrutinib is a selective, reversible BTK inhibitor capable of entering the central nervous system. The pooled analysis examined whether its effects extended across clinical relapses, imaging outcomes, disability progression and a blood marker of nerve-fiber injury.

Measure	Fenebrutinib	Teriflunomide
Participants randomized	750	747
Median time since diagnosis, years (range)	1.0	0.8
Median EDSS score (range)	2.5	2.0
Previous disease-modifying therapy use	18.1%	17.9%
Adjusted annualized relapse rate	0.06	0.13
T1 gadolinium-enhancing lesions per scan	0.08	0.32
New or enlarging T2 lesions per year	1.16	5.64

A pooled analysis of the FENhance 1 and FENhance 2 trials included 1,497 participants assigned to fenebrutinib 200 mg twice daily or teriflunomide 14 mg once daily for at least 96 weeks.

The annualized relapse rate was 0.06 with fenebrutinib and 0.13 with teriflunomide, a statistically significant difference.

Fenebrutinib was associated with a 16% lower risk of composite disability progression confirmed over 12 weeks.

The supplied fenebrutinib analysis did not include detailed safety results.

Remibrutinib Met Relapse Endpoints in Both REMODEL Trials

Novartis reported that remibrutinib outperformed teriflunomide on the primary relapse endpoint in REMODEL-1 and REMODEL-2.

	Remibrutinib annualized relapse rate	Teriflunomide annualized relapse rate
REMODEL-1	0.073	0.112
REMODEL-2	0.080	0.116

The company also reported a 29.2% reduction in the risk of disability progression confirmed over six months, with nominal statistical significance. The three-month confirmed progression measure showed a 20.5% reduction, described as a favorable trend.

More than 92% of remibrutinib-treated patients remained free of six-month confirmed disability progression over 24 months. Nominal significance warrants caution because it does not, by itself, establish that a finding met the trial’s multiplicity-adjusted criteria.

Novartis Reports Fewer Liver Enzyme Elevations

According to Novartis, the REMODEL studies identified no liver safety signal and no Hy’s Law cases.