Novartis reports positive Phase III results for oral MS drug remibrutinib

Novartis has reported positive topline results from its Phase III REMODEL-1 and REMODEL-2 clinical trials for remibrutinib, an investigational oral Bruton’s tyrosine kinase (BTK) inhibitor. The studies, which involved approximately 2,000 patients globally, demonstrated that remibrutinib significantly reduced the annualized relapse rate (ARR) in adults with relapsing multiple sclerosis (RMS) compared to teriflunomide.

The trials met primary endpoints and showed superiority across key secondary measures, including a reduction in inflammatory brain lesions detected via MRI. Novartis also reported encouraging trends regarding disability progression, specifically achieving nominal statistical significance for six-month confirmed disability progression (6mCDP).

Regarding safety, the company stated that remibrutinib was generally well tolerated and, notably, showed no apparent liver safety signals, an issue that has affected other drugs in the BTK inhibitor class. While the topline results confirm the achievement of endpoints, specific data regarding exact relapse rates, lesion counts, and detailed adverse event breakdowns are expected to be released during a late-breaking presentation in October.