Sanofi (Euronext: SAN; Nasdaq: SNY) announced the termination of its MOBILIZE Phase III trial of riliprubart (SAR445088, BIVV020) in CIDP patients refractory to standard-of-care, after an independent data monitoring committee determined the study was unlikely to demonstrate sufficient efficacy. The failure narrows Sanofi's complement inhibitor program in CIDP to a single remaining study and raises questions about whether C1s inhibition can deliver meaningful benefit in patients who have already failed conventional therapies. Riliprubart is an IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway, with the rationale that blocking upstream complement activation can interrupt the inflammatory cascades driving demyelination and axonal damage in CIDP.
The MOBILIZE study enrolled patients with CIDP refractory to standard-of-care treatment — a population defined by prior treatment failure, and therefore one of the more challenging groups to demonstrate efficacy in. The independent data monitoring committee's interim analysis concluded that the study was unlikely to achieve sufficient efficacy to meet its primary endpoint, triggering the early termination decision. No safety signals related to riliprubart were identified at the time of the interim analysis, indicating the termination was driven entirely by futility rather than tolerability concerns. Full MOBILIZE data will be analyzed to inform future research directions, as per Sanofi.
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