GeNeuro announced that the top-line results of the ProTEct-MS study confirm the excellent safety profile and tolerability of higher doses of temelimab, up to 54mg/kg, used in combination with rituximab, a high-efficacy anti-CD20 drug, thus meeting the primary endpoint of the ProTEct-MS study. This study, performed at the Karolinska Institutet's Academic Specialist Center in Stockholm under the leadership of Prof. Fredrik Piehl, enrolled 41 Multiple Sclerosis (MS) patients treated with rituximab and in whom disability was worsening in the absence of relapses. The primary outcome of the study was a safety evaluation.

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. Efficacy data (secondary & exploratory measures) demonstrated that temelimab, which had been used as a monotherapy in previous trials, showed beneficial trends on key parameters of neurodegeneration measured by MRI. These benefits were seen in a patient population that was already treated for at least one year with rituximab, a highly effective anti-neuroinflammatory medication.

Although the small study size precluded statistical demonstration of treatment effects, the analyses showed a favorable impact of temelimab in preserving neocortical anatomy and myelin integrity. The effect sizes were of comparable magnitude to those previously observed in the 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.