Sanofi has announced the discontinuation of its Phase 3 MOBILIZE clinical study evaluating riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who did not respond adequately to standard treatments.
The decision was made after an independent Data Monitoring Committee conducted a planned interim analysis of the study. According to the committee, the trial was unlikely to achieve sufficient efficacy to meet its intended objectives. Importantly, the analysis did not identify any new safety concerns related to riliprubart.
The MOBILIZE study, registered under clinical study identifier NCT06290128, was designed to evaluate the effectiveness of riliprubart in patients with treatment-refractory CIDP, a group that continues to face significant challenges despite currently available therapies.
Sanofi stated that it will work closely with investigators and clinical trial sites to ensure an orderly wind-down of the study. The company also emphasized that patient care remains a priority during the transition process. All enrolled participants will receive appropriate support and treatment planning as the study is closed.
In addition, Sanofi plans to conduct a detailed review of all data collected from the trial. The findings may help researchers better understand CIDP and guide future scientific and clinical research efforts.
Future of Other Riliprubart Studies Under Review
While the MOBILIZE study is being discontinued, Sanofi has not yet made a final decision regarding other ongoing riliprubart clinical programs. The company confirmed that it will evaluate the continuation of other studies, including the Phase 3 VITALIZE trial (NCT06290141), which is currently investigating riliprubart in CIDP patients receiving intravenous immunoglobulin (IVIg) treatment. Further updates regarding these programs are expected after additional assessments are completed.
No Impact on Sanofi's Financial Outlook
Sanofi stated that stopping the MOBILIZE trial will not result in any significant financial impact. The company also confirmed that there is no change to its financial guidance for 2026 as a result of this decision.
Understanding Riliprubart
Riliprubart, also known as SAR445088 or BIVV020, is an investigational monoclonal antibody designed to target activated C1s within the classical complement pathway of the immune system. The therapy works by selectively blocking C1s, a protein involved in inflammatory processes that can contribute to nerve damage in CIDP. Researchers believed that by inhibiting this pathway, riliprubart could potentially reduce inflammation, prevent demyelination, and protect nerve fibers from ongoing damage.
However, riliprubart remains an experimental treatment and has not been approved by any regulatory authority.
What Is CIDP?
Chronic inflammatory demyelinating polyneuropathy, commonly known as CIDP, is a rare neurological disorder that affects the peripheral nervous system.
The condition occurs when the body's immune system mistakenly attacks the protective myelin sheath surrounding nerves. This damage interferes with nerve signaling and can lead to symptoms such as:
The disease primarily affects the arms and legs and can gradually worsen over time if not properly managed.
Ongoing Challenges in CIDP Treatment
Although several treatment options are available for CIDP, many patients continue to experience significant disease burden.
According to available data:
Because of these limitations, there remains a strong need for new therapies that can provide more complete and lasting disease control.
Sanofi Continues Focus on Immunology Research
Sanofi remains focused on developing innovative medicines for immune-mediated diseases through its research and development programs. The company continues to invest in understanding the immune system and advancing therapies designed to address serious medical conditions where treatment options remain limited. While the MOBILIZE study has been discontinued, the data generated from the trial may still provide valuable insights for future research efforts in CIDP and other immune-related neurological disorders.