Experimental RRMS Therapy to Be Tested in a Phase 2b Clinical Trial
GeNeuro SA, a company developing therapies for neurological and autoimmune disorders, recently announced the initiation of a Phase 2b clinical trial to assess its lead investigational antibody GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called “CHANGE-MS,” plans to enroll 260 patients across 68 centers across the European Union and Eastern Europe.
GNbAC1 is an humanised monoclonal antibody against the multiple sclerosis-associated retrovirus (MSRV)-Env, a protein of endogenous retroviral origin expressed in MS lesions. The MSRV-Env protein is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation (oligodendrocytes are the cells producing myelin, the protective sheath around neurons that is degraded in MS).
The Phase 2b trial will be a randomized, double-blind, placebo-controlled and dose-escalation study followed by a six-month open-label phase to test GNbAC1 in RRMS patients. The study aims to assess the clinical benefit of GNbAC1 in neutralizing the MSRV-Env protein, identified as a potential key factor fueling the inflammatory and neurodegenerative components of MS. The assessment of GNbAC1’s efficacy will be based on the analysis of multiple brain magnetic resonance imaging (MRI) scans. Preliminary data are anticipated for the end of 2017.
The company also announced that Servier, its partner in developing GNbAC1, has exercised its equity investment option under a November 2014 agreement to become a minority shareholder in GeNeuro (acquiring shares from Eclosion). Under the terms of the agreement, Servier will pay GeNeuro $40 million (€37.5 million) to complete the Phase 2b trial. Subject to exercising its option for a licensing agreement, Servier has agreed to finance the global Phase 3 development program and pay GeNeuro up to an additional $355 million (€325 million) in future development- and sales-related milestones, as well as royalties on sales.
“Exercising its equity option illustrates Servier’s continued commitment to the long-term development of GeNeuro and GNbAC1, and reflects the excellent quality of the relationship that has been established with a partner that has proven to be truly synergistic with an innovative biotech like ours,” said Jesús Martin-Garcia, CEO of GeNeuro, in a press release.
“We are happy to reinforce our partnership with Geneuro at this new step in the development of GNbAc1, which can be a real breakthrough for the patients suffering from MS. We have found at Geneuro a real alignment on this objective and we are willing to contribute further to this effort in line with Servier’s mission,” added Olivier Laureau, president of Servier.
GeNeuro was created in 2006 by Eclosion, the Geneva life sciences accelerator, to be a spin-off of Institut Mérieux of France. The company develops first-in-class therapies against diseases associated with the expression of pathogenic proteins of human endogenous retroviral origin (HERV).