GeNeuro Launches Phase IIb study “CHANGE-MS”

GeNeuro SA, a pioneer of new therapies for neurology and autoimmune disorders, 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.

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.

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.

COPAXONE Approved in Japan

Teva Pharmaceutical Industries Ltd. announced the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) of once-daily COPAXONE^® (glatiramer acetate injection) 20mg injection for the prevention of relapse of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Limited (Takeda). 

In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the MHLW. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize COPAXONE^® in Japan.  

The Japanese approval for COPAXONE^® is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries. 

COPAXONE^® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE^® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.