HERV in Multiple Sclerosis (MS)

Approximately 80% of MS patients are affected by an increase of disability over time, despite the availability of highly effective drugs against inflammatory activity and relapses. GeNeuro’s focus is to address this critical unmet medical need of blocking disability progression independent of relapse activity. The results generated to date with temelimab suggest that it has the potential to bring a safe and novel treatment addressing this need for MS patients. 

The pioneering research made by GeNeuro and others led to the discovery of a potentially causal factor of multiple sclerosis: the pHERV-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 pHERV-W Env and has shown in over 200 patients treated for two years a decrease all key MRI markers associated with disease progression. 

The last clinical step of temelimab’s Phase II development is presently underway at the Karolinska Institutet’s Academic Specialist Center in Stockholm. This trial proposes one-year treatment with temelimab to patients whose disability is progressing without relapses, as they have been previously treated with rituximab, a highly potent and efficacious drug against acute disease activity. The study will assess safety, tolerability of higher doses of temelimab, as well as efficacy measures based on the latest biomarkers associated with disease