GeNeuro initiates GNbAC1 Phase IIb study in Relapsing-Remitting Multiple Sclerosis

Dec 21 2015

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.