Sanofi (NASDAQ:SNY) said on Wednesday that it has decided to discontinue the phase 3 MOBILIZE trial evaluating riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who have not responded to standard treatments.
The decision follows an interim assessment conducted by an independent data monitoring committee, which concluded that the study was unlikely to achieve sufficient efficacy endpoints. The committee also reported that no safety concerns linked to riliprubart were identified during the review.
Sanofi stated that it will assess the future of its other ongoing riliprubart programmes, including the phase 3 VITALIZE study involving CIDP patients currently receiving intravenous immunoglobulin (IVIg) therapy.
The company will work closely with investigators and clinical sites to conclude the MOBILIZE trial and ensure enrolled participants are transitioned appropriately to alternative care. Sanofi also plans to undertake a comprehensive review of the study data to help guide future research and contribute to a broader understanding of CIDP.
Management noted that ending the MOBILIZE study is not expected to result in any material financial impact, and the company reiterated that its 2026 financial guidance remains unchanged.
Riliprubart is an IgG4 humanised monoclonal antibody designed to selectively block activated C1s within the classical complement pathway of the innate immune system. The treatment remains investigational, and its safety and effectiveness have not been approved by any regulatory authority.
CIDP is a rare neurological disorder characterised by progressive muscle weakness and sensory dysfunction affecting the arms and legs. Around 30% of patients do not respond to currently available therapies, while approximately 70% of those who do respond fail to achieve a full recovery.
More about Sanofi
Sanofi is a global healthcare company focused on developing medicines and vaccines across a range of therapeutic areas, including immunology, rare diseases, oncology, neurology and vaccines. The group operates worldwide and invests heavily in research and development to advance innovative treatments for patients with unmet medical needs.