Sanofi BTK Inhibitor Reduces Relapsing MS Disease Activity in Phase 2b Trial
Sanofi's investigational brain-penetrant BTK inhibitor, SAR442168, significantly reduced disease activity in relapsing multiple sclerosis (MS) patients during a Phase 2b trial, the company reported. Four Phase 3 trials are being initiated.
Sanofi announced on April 23, 2020, that its investigational Bruton's tyrosine kinase (BTK) inhibitor, SAR442168, met primary and secondary endpoints in a Phase 2b trial evaluating efficacy and safety in relapsing forms of multiple sclerosis (MS). The oral, brain-penetrant small molecule demonstrated a significant reduction in MS disease activity as measured by MRI.
The Phase 2b study assessed multiple doses over 12 weeks. For the primary endpoint measuring new gadolinium-enhancing T1 lesions, the 60mg dose achieved an 85% relative reduction compared to placebo. The secondary endpoint, measuring new or enlarging T2 lesions, showed an 89% relative reduction with the same dose.
SAR442168 is designed to modulate both adaptive and innate immune cells, including central nervous system microglia, which are implicated in MS-related neuroinflammation and neurodegeneration. Sanofi plans to initiate four Phase 3 clinical trials to further evaluate the drug in both relapsing and progressive forms of MS.
Approximately 1.2 million people in the U.S. and Europe have MS. Despite current treatments, many patients experience ongoing disability accumulation. Sanofi believes its BTK inhibitor shows promise in potentially addressing neuroinflammation and neurodegeneration, key drivers of disability progression in MS.