Sanofi has reported one-year follow-up findings from an ongoing Phase II clinical trial of its complement C1s inhibitor, riliprubart, in chronic inflammatory demyelinating polyneuropathy (CIDP) patients.
The international, open-label, multi-centre study assessed riliprubart in CIDP patients across three cohorts.
These arms included subjects who had received standard of care and were separated into SOC-treated, SOC-refractory, or SOC-naïve.
Participants received the treatment for 24 weeks in the part A portion, followed by an optional treatment extension for 52 weeks in the part B segment.
According to the latest data, the treatment showed encouraging efficacy and safety in trial subjects.
In part A, riliprubart offered disease-controlling benefits, with improving or stable disease, including those who failed or had an inadequate response to SOC treatment, as well as those with residual disability on SOC.
In part B, the inhibitor offered disease-controlling benefits in all cohorts.
The therapy was also shown to improve subject-reported fatigue and quality-of-life measurements, as well as biomarkers linked to CIDP disease progression.
Among the SOC-treated, SOC-refractory, and SOC-naïve subjects, 87%, 89%, and 92%, respectively, showed improvement or were stable when switching from SOC treatment to riliprubart after 24 weeks.
Riliprubart was also demonstrated to have a favourable safety profile, with headache, nasopharyngitis, and Covid-19 being the most frequently seen adverse events.
Sanofi Neurology Development global head Erik Wallström said: “CIDP is a debilitating disease, often with challenging comorbidities, and nearly a third of patients fail to respond or do not adequately respond to available therapies.
“Our riliprubart CIDP study is the only one evaluating a broad spectrum of participants, including those who experienced failure of standard-of-care therapy, as well as the first study to investigate neurofilament light chain levels as a key biomarker of CIDP progression. These results bring us hope that riliprubart may reduce disability and underlying nerve cell damage, further validating our ongoing CIDP Phase III studies.”
Last month, the company reported positive outcomes from a Phase II trial of rilzabrutinib for adults with uncontrolled moderate-to-severe asthma.
