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Clinical Trials

Date: 2018-01-09

Type of information: Completion of patient enrollment

phase: 2a

Announcement: completion of patient enrollment

Company: Geneuro (Switzerland)

Product: GNbAC1

Action mechanism:

  • monoclonal antibody. The monoclonal antibody GNbAC1 targets the envelope protein MSRV-Env of an endogenous retrovirus which could play a critical role in the pathogenesis of multiple sclerosis. Discovered in the early 90’s, the Human endogenous retrovirus of type W is closely associated with multiple sclerosis and, due to its neurotoxic properties, could be a causal factor of the disease. This retrovirus is normally latent in the genome of individuals, but it can be re-activated by certain co-factors to expresses a pathogenic protein, MSRV-Env. Recent evidence has demonstrated that this ENV-protein is expressed in multiple sclerosis lesions from an early stage, is pro-inflammatory and inhibits remyelination. By neutralizing MSRV-ENV, GNbAC1 could block a key factor promoting the inflammation on the plaques, as well as allowing the remyelination repair process to restart.
  • This protein has also been detected in the pancreas of patients with type 1 diabetes. It is thought to be a causal factor of these diseases.
  • The development of GNbAC1 is the result of 25 years of research into human endogenous retroviruses (HERVs), including 15 years with the Mérieux Institute and INSERM, before GeNeuro was founded in 2006.

Disease: type 1 diabetes

Therapeutic area: Autoimmune diseases - Metabolic diseases

Country: Australia

Trial details:

  • The monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous Multiple Sclerosis associated RetroVirus (MSRV), which could play a critical role in different autoimmune disorders, notably type 1 diabetes (T1D).
  • This study is a multicentre study evaluating for the first time the safety and efficacy of GNbAC1 in T1D subjects for a first bouble-blind period of 20 weeks followed by an optional open-label period of 24 weeks. The primary objective of the study is to assess the safety and tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D. Secondary objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of T1D. (NCT03179423)

Latest news:

  • • On January 9, 2018, GeNeuro  announced that patient enrollment in its Australian Phase 2a study of GNbAC1 in type 1 diabetes has been completed on schedule. A total of 60 adult patients in more than 10 centers have been recruited into the study. The primary endpoint is the safety of GNbAC1 in this new population of patients. Secondary endpoints will measure the link between treatment response and pHERV-W Env biomarkers, insulin production based on peptide C levels, and other biomarkers associated with type 1 diabetes, such as insulin consumption, glycaemia and production of diabetic auto-antibodies.

Is general: Yes