GeNeuro has announced a collaboration for a new clinical trial of temelimab in multiple sclerosis (MS) with clinical researchers of Karolinska Institutet and the Academic Specialist Center (ASC), Stockholm, Sweden.
This single-center study will be led by Dr. Fredrik Piehl, Professor of Neurology at the Department of Clinical Neurosciences of the Karolinska Institutet, and head of research at the MS clinic at ASC.
The largest MS center in Sweden
The trial will be conducted at Center for Neurology of ASC, the largest MS center in Sweden with approximately 2,400 patients. The one-year trial 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. The study aims to start enrolling patients in Q1 2020.
“It is evident that currently available disease modulatory therapies for MS exert very limited effects on the progressive aspect of MS and that this phase starts early in the disease course. A role of pHERV-W Env in progressive disease worsening is supported by accumulating preclinical and clinical evidence. We are excited to explore the therapeutic potential of temelimab in patients progressing without relapses. This constitutes a key unmet medical need in MS and will allow us to push the boundaries of current therapeutic possibilities,” said Prof. Fredrik Piehl, Principal Investigator of the study.
Temelimab is a monoclonal antibody designed to neutralize a pathogenic envelope protein, pHERV-W Env, which has been shown to activate microglia in the brain resulting in an aggressive phenotype attacking myelin, and to impair the remyelination capacity of the brain through the inhibition of oligodendrocyte precursor cell differentiation. This collaboration follows the data from GeNeuro’s ANGEL-MS clinical trial results, presented at ECTRIMS, which demonstrated positive results at two years on key markers associated with disease progression.
“Long-term data have confirmed the neuroprotective effect of temelimab in MS and demonstrated its potential to make significant improvements in the lives of patients. We are very proud to be working with Prof. Piehl, who is recognized for his leading research at the Karolinska Institutet and the ASC, to further advance the development of temelimab as a potential treatment against disability progression in MS,” said Jesús Martin-Garcia, CEO of GeNeuro.