title: A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients - a twelve month follow-up.
abstract: GNbAC1 is a humanized monoclonal antibody targeting MSRV-Env, an endogenous retroviral protein, which is expressed in multiple sclerosis (MS) lesions, is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation. This paper describes the open-label extension up to 12months of a trial testing GNbAC1 in 10 MS patients at 2 and 6mg/kg. The primary objective was to assess GNbAC1 safety, and other objectives were pharmacokinetic and pharmacodynamic assessments. During the extended study, no safety issues occurred in the 8 remaining patients. No anti-GNbAC1 antibodies were detected. GNbAC1 appears well tolerated.
authors.affiliation: Neurology Department, Basel University Hospital, Petersgraben 4, Basel, Switzerland.
authors.forename: Tobias
authors.initials: T
authors.lastname: Derfuss
authors.affiliation: GeNeuro SA, Chemin des Aulx 18, CH 1228 Plan-les-Ouates, Geneva, Switzerland. Electronic address: fc@geneuro.com.
authors.forename: François
authors.initials: F
authors.lastname: Curtin
authors.affiliation: Neurology Department, Basel University Hospital, Petersgraben 4, Basel, Switzerland.
authors.forename: Claudia
authors.initials: C
authors.lastname: Guebelin
authors.affiliation: Department of Clinical Neurosciences, Division of Neurology, Unit of Neuroimmunology and Multiple Sclerosis, Geneva University Hospital, 1211 Geneva, Switzerland.
authors.forename: Claire
authors.initials: C
authors.lastname: Bridel
authors.affiliation: Neurology Department, Basel University Hospital, Petersgraben 4, Basel, Switzerland.
authors.forename: Maria
authors.initials: M
authors.lastname: Rasenack
authors.affiliation: Pharmacology and Toxicology Division & Clinical Trial Unit, Geneva University Hospital, Rue Gabrielle Perret-Gentil, 1214 Geneva, Switzerland.
authors.forename: Alain
authors.initials: A
authors.lastname: Matthey
authors.affiliation: Neurology Department, Lausanne University Hospital, Rue du Bugnon 46, 1011 Lausanne, Switzerland.
authors.forename: Renaud
authors.initials: R
authors.lastname: Du Pasquier
authors.affiliation: Neurology Department, Lausanne University Hospital, Rue du Bugnon 46, 1011 Lausanne, Switzerland.
authors.forename: Myriam
authors.initials: M
authors.lastname: Schluep
authors.affiliation: Pharmacology and Toxicology Division & Clinical Trial Unit, Geneva University Hospital, Rue Gabrielle Perret-Gentil, 1214 Geneva, Switzerland.
authors.forename: Jules
authors.initials: J
authors.lastname: Desmeules
authors.affiliation: GeNeuro SA, Chemin des Aulx 18, CH 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Alois B
authors.initials: AB
authors.lastname: Lang
authors.affiliation: GeNeuro SA, Chemin des Aulx 18, CH 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Hervé
authors.initials: H
authors.lastname: Perron
authors.affiliation: GeNeuro SA, Chemin des Aulx 18, CH 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Raphael
authors.initials: R
authors.lastname: Faucard
authors.affiliation: GeNeuro SA, Chemin des Aulx 18, CH 1228 Plan-les-Ouates, Geneva, Switzerland; Pharmacology Department, University of Pretoria, South Africa.
authors.forename: Hervé
authors.initials: H
authors.lastname: Porchet
authors.affiliation: Neurology Department, Heinrich Heine University, Moorenstrasse 5, D-40225 Düsseldorf, Germany.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Hartung
authors.affiliation: Neurology Department, Basel University Hospital, Petersgraben 4, Basel, Switzerland.
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.affiliation: Department of Clinical Neurosciences, Division of Neurology, Unit of Neuroimmunology and Multiple Sclerosis, Geneva University Hospital, 1211 Geneva, Switzerland; Department of Genetic and Laboratory Medicine, Division of Laboratory Medicine, Geneva University Hospital, 1211 Geneva, Switzerland; Department of Pathology and Immunology, Faculty of Medicine, University of Geneva, 1211 Geneva, Switzerland.
authors.forename: Patrice H
authors.initials: PH
authors.lastname: Lalive
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology / Q000627:therapeutic use*; D015331:Cohort Studies; D020077:Endogenous Retroviruses / Q000187:drug effects* / Q000276:immunology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000276:immunology; D014759:Viral Envelope Proteins / Q000037:antagonists & inhibitors* / Q000276:immunology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D014759:Viral Envelope Proteins; C581064:temelimab
keywords: Clinical trial; Human endogenous retrovirus; Monoclonal antibody; Multiple sclerosis; Safety