Novartis posts strong Phase III data for remibrutinib

Novartis (NVS) announced positive Phase III results from its REMODEL-1 and REMODEL-2 trials, showing that remibrutinib delivered comprehensive disease control in adults with relapsing multiple sclerosis. The oral Bruton’s tyrosine kinase inhibitor demonstrated superior relapse control and a clinically meaningful delay in disease progression compared with teriflunomide, the active comparator in the studies. These pivotal data were presented on October 23, 2026, and support describing remibrutinib as providing robust efficacy with a favorable safety profile in this patient population.

Across both REMODEL trials, remibrutinib significantly reduced the annualized relapse rate versus teriflunomide, achieving a statistically significant and clinically meaningful relative reduction of 35.2%.

In terms of disability progression, remibrutinib achieved a clinically meaningful delay. The risk of 6‑month confirmed disability progression was reduced by 29.2% compared with teriflunomide, with a consistent positive trend showing a 20.5% reduction in 3‑month confirmed disability progression. Over a 24‑month period, more than 92% of patients receiving remibrutinib remained free from disease progression as assessed by 6‑month confirmed disability progression, highlighting sustained control of disability.

Remibrutinib also showed superiority on all key secondary endpoints within each trial, notably in measures of brain lesion activity on MRI. Compared with teriflunomide, the drug significantly reduced annualized T2 lesion activity, a marker of chronic disease burden, and significantly lowered the rate of Gd+ T1 lesions per scan, a marker of active inflammation. Reductions in T2 lesion activity were 65% and 70%, and Gd+ T1 lesions were reduced by 66% across the two trials.

Serum neurofilament light chain outcomes improved with remibrutinib, with a 9.0% improvement in REMODEL‑1, indicating a favorable impact on a biomarker of neuroaxonal injury.

Safety findings from the Phase III program indicated that remibrutinib maintained a robust safety profile consistent with its broader development program. No liver safety signal was observed, including no Hy’s Law cases, which have been reported in other late‑stage BTK inhibitor programs. Across both REMODEL trials, patients treated with remibrutinib experienced fewer liver enzyme elevations at every threshold than those on teriflunomide.

For alanine aminotransferase levels greater than three times the upper limit of normal, 2.0% of patients on remibrutinib were affected compared with 7.4% on teriflunomide, with the remibrutinib rate in line with placebo groups seen in prior relapsing multiple sclerosis studies. Numerically fewer patients on remibrutinib experienced adverse events and serious adverse events, and treatment discontinuations due to adverse events were nearly 50% fewer with remibrutinib than with teriflunomide. Two deaths occurred in the remibrutinib group and were assessed by investigators as unrelated to the study treatment.

REMODEL‑1 and REMODEL‑2 are identical multicenter, randomized, double‑blind, active comparator‑controlled Phase III studies in adult patients with relapsing multiple sclerosis. Approximately 2,000 patients globally with evidence of recent disease activity and an Expanded Disability Status Scale score between 0.0 and 5.5 were randomized 1:1 to receive remibrutinib 100 mg or teriflunomide. The core double‑blind portion of the studies has a flexible duration of up to 30 months, followed by an open‑label extension of up to five years.

Remibrutinib is described as a highly selective, covalent, oral BTK inhibitor designed to block the BTK pathway, reducing activation of B cells and innate immune cells to modulate immune regulatory networks and related neuroinflammation. It has been designed to modulate BTK signaling without chronic B‑cell depletion, providing a differentiated approach to immune regulation. The same molecule, under the brand name Rhapsido, has received regulatory approvals for chronic spontaneous urticaria, and is also being studied in other immune‑mediated conditions.