GeNeuro and Karolinska Institute collaborate in multiple sclerosis

The 12-months trial, which will kick-off in QI/2020, will be led by Dr. Fredrik Piehl, head of research at the MS clinic at ASC in Stockholm, which is home to approximately 2,400 patients. It will enroll patients whose disability progresses without relapses, and will document the safety and tolerability of temelimab following higher doses, as well as efficacy based on the latest biomarkers associated with disease progression.

Geneuro’s temelimab targets pHERV-W Env, the envelope protein of a Human Endogenous Retrovirus (HERV). Based on Phase IIb data, Geneuro believes its expression to be reactivated in order to trigger activation of microglia, the brain’s immune system resulting myelin destruction. Furthermore, the reactivated endogenous gene may impair the remyelination capacity of the brain through the inhibition of oligodendrocyte precursor cell differentiation.

The development of temelimab (GNbAC1) is the result of 25 years of research into human endogenous retroviruses (HERVs), before GeNeuro was founded in 2006. HERVs are present in the human genome and some have been associated with various auto-immune diseases. The viral envelope protein encoded by a HERV in the HERV-W family (pHERV-W Env) has been found in MS patients and particularly in active lesions, as well as in the pancreas in type-1 diabetes patients. By neutralising pHERV-W Env, temelimab could simultaneously block the pathological inflammation process and restore the remyelination process in MS patients, and maintain insulin production in type-1 diabetes patients