HERV in Multiple Sclerosis (MS)
The pioneering research made by GeNeuro and others led to the discovery of a potentially causal factor of multiple sclerosis: the HERV-W Env (or “W-ENV”) protein, which is present in the brain of MS patients and has been observed to activate microglial cells into aggressive phenotypes attacking myelin, and to hamper the remyelination capacity of oligodendrocyte precursor cells. These are two of the core mechanisms creating permanent damage to the brain and fueling the long term progression of disability in MS patients.
GeNeuro has developed temelimab, a monoclonal antibody having completed Phase II clinical development, as a treatment for multiple sclerosis. Temelimab neutralizes W-ENV and has shown in almost 250 patients treated a decrease of all key imaging and soluble biomarkers associated with disease progression.
The last clinical step of temelimab’s Phase II development has been completed at the Karolinska Institutet’s Academic Specialist Center in Stockholm, with results presented at ECTRIMS 2022 in Amsterdam. This trial offered one-year treatment with temelimab to patients whose disability was progressing without relapses, as they were previously treated with rituximab, a highly potent and efficacious drug against acute disease activity. The primary endpoint of this study was met, with results confirming the excellent safety profile and tolerability of higher doses of temelimab administered concomitantly with rituximab, an anti-CD20 treatment, a high-efficacy anti-inflammatory drug.
Efficacy data, obtained in this patient group already effectively treated against inflammation, showed that temelimab has a favorable impact on key MRI parameters measuring neurodegeneration, while new exploratory data on soluble biomarkers also showed favorable impact on measures of neurodegeneration at one year. The results on these biomarkers confirm the synergistic potential to treat neurodegeneration with temelimab in addition to a high-efficacy anti-inflammatory therapy in MS.