GeNeuro Phase 2 aiming HERVs in multiple sclerosis, first time with benefit shown in clinical trial

GeNeuro’s results from the Phase 2b study of its novel therapeutic treatment of multiple sclerosis (MS) showed a significant, consistent positive impact on key neuroprotection markers known to be linked to disease progression, which is the first time that the benefit of a treatment targeting endogenous retrovirus protein is shown in a clinical trial, GeNeuro said.The study was conducted with 270 patient in 12 European countries, with MRI showing a coherent neuroprotective benefit on brain atrophy and benefits were seen in cortical and thalamic atrophy. GeNeuro said the whole brain atrophy revealed a 29% relative reduction in brain volume loss over 12 months for the highest dose versus the control group.
For most MRI measures of neuroinflammation, all groups improved from Month 6 to Month 12, however there was no significant separation between treatment groups. The trend seen in post-hoc analyses at 6 months on neuroinflammatory markers, after the primary endpoint of reducing the total number of cerebral Gadolinium-enhancing lesions as measured by MRI was not met, did not translate into a relevant result at 12 months, GeNeuro said.
Jesús Martin-Garcia, CEO of GeNeuro said: “These clinical results support GeNeuro’s efforts to develop this approach in other HERV-related diseases such as Type 1 Diabetes, CIDP[3] 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.

Dr. Christian de Bodinat, Director of Servier’s Neuro-psychiatry Centre for Therapeutic Innovation, said: “Based on this joint achievement, we will now assess the next development steps with our partner to bring these benefits to patients.” 

GeNeuro is presently conducting a 60-patient Phase IIa with GNbAC1 in T1D with expected top line results in September 2018, and has received an Orphan Drug Designation from the FDA for GNbAC1 in CIDP. In 2017, GeNeuro entered into a research agreement with the US NIH for developing new approaches against pHERV-K protein as a target in the treatment of Amyotrophic Lateral Sclerosis (ALS).

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.