GeNeuro’s ProTEct-MS Phase 2 Trial Data, Presented at the ECTRIMS 2022 Congress in Amsterdam, Confirms Synergistic Neuroprotective Potential of Temelimab in MS

Regulatory News:

GeNeuro (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC, long-COVID or post-COVID), today announced that the primary analysis of the Phase 2 ProTEct-MS study was presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2022) Congress in Amsterdam, Netherlands, by Dr. Fredrik Piehl, Professor of Neurology at the Department of Clinical Neurosciences of the Karolinska Institutet, head of research at the MS clinic of the Academic Specialist Center (ASC), and Principal Investigator of the study.

The ProTEct-MS study enrolled a very homogenous cohort of 42 patients being treated with temelimab (18, 36 and 54mg/kg) vs. placebo for 48 weeks. The patients included in the study had confirmed disability progression without relapses, following previous treatment with the anti-CD20 drug rituximab, a highly potent and efficacious drug against relapses and brain lesion formation. The one-year Phase 2 trial, conducted at the Karolinska Institutet’s ASC in Stockholm, Sweden, evaluated the administration of temelimab in patients with relapsing remitting MS to address disease progression independent of relapses following treatment with rituximab.

The data presented showed that, after one year of treatment, temelimab appeared to be a safe add-on to anti-CD20 treatment. The drug was well tolerated with no treatment related discontinuations, no serious or severe treatment emergent adverse events, and no differences in overall clinical or laboratory safety findings, which meets the primary endpoint of the study.

Also, as already announced in the top-line results in March 2022, MRI biomarkers showed a favourable impact of temelimab in preserving neocortical anatomy and myelin integrity. The effect sizes were of comparable magnitude to those previously observed in the prior CHANGE-MS and ANGEL-MS trials. The combined treatment of temelimab and rituximab protected against loss of cortical thickness by more than 50% relative to rituximab alone. Furthermore, cortical tissue integrity, as measured by magnetization transfer saturation, was improved with temelimab, potentially reflecting remyelination.