GENEVA & SURESNES, France--(BUSINESS WIRE)--GeNeuro SA, a pioneer of new therapies for neurology and autoimmune disorders, announced today that it has initiated its planned Phase IIb study “CHANGE-MS” (Clinical trial assessing the HERV-W Env ANtagonist GNbAC1 for Efficacy in Multiple Sclerosis) with its lead antibody GNbAC1 in Relapsing-Remitting Multiple Sclerosis (RRMS). The study plans to enroll 260 patients in 68 clinical centers in the European Union and Eastern Europe. Preliminary results are expected by the end of 2017.
Simultaneous with the start of Phase IIb, development partner Servier has exercised its equity investment option, as part of an agreement signed in November 2014, to become a minority shareholder in GeNeuro by purchasing shares from existing shareholder Eclosion2. The terms of the partnership agreement provide for GeNeuro to receive US$40 (€37.5) million from Servier for the completion of the Phase IIb study. Subject to exercising its option for a licensing agreement, Servier has agreed to finance the global Phase III development program and pay GeNeuro up to an additional US$355 (€325) million in future development and sales related milestones, as well as royalties on future sales.
The aim of the Phase IIb study is to demonstrate on RRMS patients the clinical benefit of GNbAC1 in neutralizing the MSRV-Env protein, which has been identified as a potential key factor fueling the inflammatory and neurodegenerative components of MS. Efficacy will be based on multiple brain magnetic resonance imaging scans, with an initial endpoint analysis after 6 months followed by a 6-month extension. By targeting MSRV-Env, GeNeuro aims to bring to patients a safe and effective treatment for both relapsing-remitting and progressive forms of the disease without hampering the patient’s immune system.
“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,” stated Jesús Martin-Garcia, CEO of GeNeuro.
“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.
“Servier is willing to bring to patients innovative treatments targeting serious diseases with major unmet medical needs. This Phase IIb study will assess both the efficacy and the safety of a novel disease modifying approach representing a potential unprecedent progress in the treatment of MS,” underlined Christian de Bodinat, Director of the Neuro-psychiatry Therapeutic Innovation Center.
About GeNeuro and its technology
GeNeuro was created in 2006 by Eclosion, the Geneva life sciences accelerator, as a spin-off of Institut Mérieux of France. It develops first-in-class therapies against diseases associated with the expression of pathogenic proteins of human endogenous retroviral origin (HERV). GeNeuro’s lead product, GNbAC1, is a therapeutic antibody that targets MSRV-Env, a protein expressed in Multiple Sclerosis (MS) lesions from an early stage, which has been shown to be both pro-inflammatory and an inhibitor of remyelination, the two major drivers of MS progression.
The Multiple Sclerosis associated retrovirus (MSRV) is normally latent in the genome of individuals, but it can be re-activated by viral infections and other co-factors to express a pathogenic protein, MSRV-Env. MSRV-Env provides a missing link between the observation that viral infections are associated with the onset of the disease and expression of the pathogenic factor (the MSRV-Env protein), which can then explain the inflammatory and demyelinating characteristics of MS.
By targeting a potential key factor present in all types of MS that fuels both inflammation and neurodegeneration, GeNeuro aims to bring to patients a safe, long-term treatment with the potential to reduce or stop progression of the disease. As the first drug intended to address a potential causal factor of the disease, it may radically change the way MS patients are treated.
Further information can be found at: www.geneuro.com.
Servier is an independent French-based pharmaceutical company with a strong international presence in 145 countries. It employs more than 21,000 people. Its development is driven by the pursuit of innovation in the therapeutic areas of cancer, cardiovascular, metabolic, central nervous system, psychiatric, bone, muscle and joint diseases. In 2014, the company recorded a turnover of €4 billion. 28% of this turnover was reinvested in Research and Development.