By VETTAPHARMA reporter – Derek Roche: Sanofi announced that it will discontinue the Phase 3 MOBILIZE study (NCT06290128) evaluating riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who were refractory to standard-of-care treatment.
The decision follows a planned interim analysis conducted by an independent data monitoring committee, which concluded that the study was unlikely to demonstrate sufficient efficacy.
Importantly, no new safety signals related to riliprubart were identified during the interim review. Sanofi stated that it will work with investigators and study sites to ensure an orderly wind-down of the trial and appropriate transition of care for enrolled participants.
The company also noted that the future of other ongoing riliprubart development programs, including the VITALIZE Phase 3 study (NCT06290141) in intravenous immunoglobulin (IVIg)-treated CIDP patients, will be evaluated in light of the MOBILIZE findings.
Riliprubart (SAR445088, BIVV020) is an investigational IgG4 humanized monoclonal antibody designed to selectively inhibit activated C1s within the classical complement pathway. The therapy is being studied for its potential to reduce inflammatory mechanisms associated with demyelination and axonal damage in CIDP.
Sanofi plans to conduct a comprehensive analysis of the MOBILIZE dataset to better understand the outcome and inform future research efforts in CIDP. The company stated that terminating the study will not result in significant financial costs and does not affect its 2026 financial guidance.
CIDP is a rare neurological disorder characterized by progressive weakness and sensory impairment in the arms and legs. According to Sanofi, approximately 30% of patients do not respond to currently available therapies. Among those who do respond, around 70% experience only partial improvement, while fewer than one-third achieve sustained remission without ongoing treatment.
Quick FAQs
1. What Is Riliprubart?
Riliprubart (SAR445088, BIVV020) is an investigational IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system.
2. What Happened?
Sanofi announced the discontinuation of the Phase 3 MOBILIZE study after an independent interim analysis determined that the trial was unlikely to demonstrate sufficient efficacy in treatment-refractory CIDP patients.
3. What Is The MOBILIZE Study?
MOBILIZE (NCT06290128) is a Phase 3 clinical trial evaluating riliprubart in patients with chronic inflammatory demyelinating polyneuropathy who were refractory to standard-of-care treatment.
4. What Is Chronic Inflammatory Demyelinating Polyneuropathy?
CIDP is a rare immune-mediated neurological disorder in which the immune system attacks the myelin sheath surrounding peripheral nerves, leading to progressive weakness and sensory dysfunction.
5. What Were The Key Results?
An interim analysis by an independent data monitoring committee found that the study was unlikely to provide sufficient efficacy. No safety signals related to riliprubart were identified during the review.
6. Why Is This Important?
The decision represents a setback for riliprubart’s development in refractory CIDP, a population with substantial unmet medical need. The findings may also influence the evaluation of Sanofi’s ongoing VITALIZE Phase 3 study while contributing additional scientific insights into CIDP treatment research.
