GeNeuro SA announced 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…
Source: Geneuro