GeNeuro: 12-month-results underpinning hope

MS is a disease of the central nervous system (brain and spinal cord) that affects more than two million people worldwide. It is a consequence of inflammatory and neurodegenerative processes leading to damage of the protective myelin sheath surrounding the neurons, and of the neurons themselves, what is called neurodegeneration.

The data of GeNeuro’s trial showed that GNbAC1 administration had a significant, consistent positive impact on key neuroprotection markers known to be linked to disease progression. This is the first time that the benefit of a treatment targeting endogenous retrovirus protein is shown in a clinical trial.

“What is impressive is the consistency of the effect already observed at one year across all these key markers of neurodegeneration, and that this effect appears to be independent from an anti-inflammatory action,” noted Prof Hans-Peter Hartung, chairman of the Department of Neurology of the University Hospital Düsseldorf and Lead Investigator of the study. “These positive effects are very promising, and may open new doors towards addressing the key unmet medical need of disease progression in MS.”
 
“The positive impact of GNbAC1 on neuroprotection markers opens a novel therapeutic perspective for MS, in line with Servier’s ongoing commitment to bringing new, safe and effective treatments to patients. Based on this joint achievement, we will now assess the next development steps with our partner to bring these benefits to patients,” stated Dr. Christian de Bodinat, Director of Servier’s Neuro-psychiatry Centre for Therapeutic Innovation.

Achieving these positive Phase 2b results through the neutralization of pathogenic HERV-W protein supports its causal role in the neurodegenerative mechanisms of MS. GNbAC1 may provide a safe treatment option against neurodegeneration unrelated to inflammation in all forms of the disease, a major objective that is not addressed by currently available MS treatments.
 
“These results are a significant success for GeNeuro as they demonstrate the role played by pathogenic HERV-W protein in patients affected by MS. It supports the concept of altering the neurodegenerative course of MS by treating a causal factor of the disease, as suggested by preclinical research,” stated Jesús Martin-Garcia, CEO of GeNeuro. “These clinical results support GeNeuro’s efforts to develop this approach in other HERV-related diseases such as Type 1 Diabetes, CIDP and Amyotrophic Lateral Sclerosis”.

CHANGE-MS Phase 2b study was fully funded through a €362.5 million partnership signed with Servier in 2014, in which Servier is involved in the development and potential commercialization of GNbAC1 in MS in territories ex USA and Japan.

About GNbAC1
The development of GNbAC1 is the result of more than 25 years of research into human endogenous retroviruses (HERVs), including 15 years at Institut Mérieux and INSERM, a French national medical research institute. Found in the human genome, certain HERVs have been linked to various autoimmune and neurodegenerative diseases. The retroviral envelope protein, encoded by a pathogenic member of the HERV-W family (pHERV-W env) has been identified in brain lesions of patients with MS, particularly in active lesions, and in the pancreas of type 1 diabetes (T1D) patients. By neutralizing pHERV-W env, GNbAC1 could at the same time block pathological inflammatory processes and restore remyelination in MS patients and maintain insulin production in T1D patients. As pHERV-W env has no known physiological function, GNbAC1 is expected to have a good safety profile, without affecting the patient’s immune system, as observed in all clinical trials to date.

(Press release)