Saturday, July 13, 2024

Riliprubart Shows Promising Results in Treating Chronic Inflammatory Demyelinating Polyneuropathy

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Sanofi’s complement C1s inhibitor, riliprubart, has shown encouraging efficacy and safety for participants with chronic inflammatory demyelinating polyneuropathy (CIDP) in an ongoing phase 2 study. The latest findings were presented at the 2024 Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada.

The study evaluated riliprubart across three separate participant cohorts, including those who had failed or had an inadequate response to standard-of-care (SOC) treatment and those who had never received treatment. The results demonstrated a rapid and durable reduction of key biomarkers, including those associated with the classical complement pathway and nerve cell damage, indicating the potential of riliprubart as a first-in-class treatment for demyelinating polyneuropathy.

Efficacy and Safety Across Cohorts on Demyelinating Polyneuropathy

Luis Querol Gutierrez, MD, PhD, from the Department of Neurology at Hospital de la Santa Creu i Sant Pau in Barcelona, Spain, highlighted the significant unmet need for effective demyelinating polyneuropathy treatments. “Many people living with CIDP do not fully respond to available therapies or do not respond at all,” said Gutierrez.

“These phase 2 data for riliprubart are encouraging, as they suggest that riliprubart’s unique mechanism of action reduces the overactive, damaging complement pathways that may drive disease progression.” The study showed that riliprubart improved participant-reported fatigue and quality-of-life measurements, demonstrating its potential to transform the treatment paradigm for CIDP patients.


Phase 2 Study Results

In the phase 2 study, participants with demyelinating polyneuropathy were divided into three cohorts: SOC-treated, SOC-refractory, and SOC-naïve. The results from part A (24 weeks) and part B (one year follow-up) showed that riliprubart was effective across all cohorts. For SOC-treated participants, 87% improved or remained stable after switching from their previous SOC treatment to riliprubart after 24 weeks, with 52% showing improvement beyond their previous therapy. For SOC-refractory participants, 89% improved or remained stable with riliprubart after 24 weeks, with 50% showing improvement. For SOC-naïve participants, 92% improved or remained stable with riliprubart after 24 weeks.

Riliprubart also reduced neurofilament light chain (NfL) levels across all three cohorts throughout the initial 24 weeks and the additional year of treatment, indicating a reduction in disease activity and underlying nerve cell damage. The outcomes included reductions in the RASCH-built Fatigue Severity Scale and improvements in the EuroQoL Visual Analogue Scale, a health-related quality of life assessment. These results bring hope that riliprubart may reduce disability and underlying nerve cell damage, further validating ongoing demyelinating polyneuropathy phase 3 studies.

Safety Profile and Phase 3 Studies

Riliprubart had a manageable safety profile throughout the study. Treatment-emergent adverse events (TEAEs) occurred in 64.6% of SOC-treated and 88.9% of SOC-refractory participants. Two deaths were reported in participants with significant medical comorbidities aside from CIDP. The most common adverse events across all cohorts were headache, nasopharyngitis, and COVID-19. Sanofi has initiated two global phase 3 studies evaluating riliprubart in adults with CIDP who have failed or had an inadequate response to SOC treatment (MOBILIZE) and in adults with demyelinating polyneuropathy receiving maintenance treatment with intravenous immunoglobulin (VITALIZE).

CIDP is a rare neurological condition causing progressive weakness and sensory impairment in the arms and legs. It occurs when the immune system attacks the myelin sheaths around nerve cells in the peripheral nervous system. Timely diagnosis and treatment are crucial to prevent long-term disability. Despite available therapies, many individuals experience residual symptoms leading to long-term morbidity and diminished quality of life. Approximately 30% of demyelinating polyneuropathy patients do not respond to standard therapies, and about 70% of those who do respond have incomplete responses.

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Resource: Sanofi, June 25, 2024

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