GeNeuro announced today that its GNbAC1 humanized monoclonal antibody was found to have a very good safety profile when administered to patients with relapsing and progressive forms of Multiple Sclerosis as part of a Phase 2a study. GNbaC1 is a first-in-class monoclonal antibody targeting a toxic protein of endogenous retroviral origin that has been identified as a potential key factor in the onset and development of multiple sclerosis. Enrollment of patients into a multinational Phase 2b study is expected to begin during the first half 2014.
“The safety data achieved in this Phase IIa study is excellent and supports the future development of GNbaC1 in both relapsing remitting and progressive MS” commented François Curtin CEO of GeNeuro. “While presenting at the recent ECTRIMS1 congress in Copenhagen last month GeNeuro’s approach was highlighted as one of the most innovative and promising new treatments in clinical development against MS as it specifically targets a potential causal factor of the disease.”
In the completed Phase 2a clinical study including a six-month extension conducted to establish safety and pharmacokinetics GNbAC1 demonstrated very good safety following repeated administration at 2 mg/kg and 6 mg/kg. The repeated administrations did not affect the immune system the TLR4 function was preserved and no signs of induction of immunogenicity were observed.
About the ENV toxic Protein and its role in Multiple Sclerosis and other pathologies
The sequencing of the human genome revealed human endogenous retroviruses (HERV) represent more than 8% of the human genome and result from the integration of exogenous retroviruses DNA during the primate evolution.
The Multiple Sclerosis associated retrovirus (MSRV) is a member of the HERV-W family and was initially isolated in cell cultures from patients affected with Multiple Sclerosis in the 90’s. MSRV 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 MS lesions from an early stage is pro-inflammatory and inhibits remyelination.
GeNeuro is a Swiss-based company created by Eclosion in 2006 as a spin-off of bioMérieux and co-funded by Eclosion and the Institut Mérieux. GeNeuro is developing first-in-class therapies against diseases associated with human endogenous retroviruses expression. Its lead product GNbAC1 targets MSRV-ENV protein closely linked to the onset and development of Multiple Sclerosis. Endogenous retroviral proteins are also associated with other diseases including Type 1 diabetes schizophrenia and chronic inflammatory demyelinating polyneuropathy (CIDP).
Further information can be found at: www.geneuro.com.
1 European Committee for Treatment and Research in Multiple SclerosisBusiness Wire
Last updated on: 04/11/2013