Experimental RRMS Therapy to Be Tested in a Phase 2b Clinical Trial

Experimental RRMS Therapy to Be Tested in a Phase 2b Clinical Trial

GeNeuro SA, a company developing therapies for neurological and autoimmune disorders, recently announced the initiation of a Phase 2b clinical trial to assess its lead investigational antibody GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called “CHANGE-MS,” plans to enroll 260 patients across 68 centers across the European Union and Eastern Europe.

GNbAC1 is an humanised monoclonal antibody against the multiple sclerosis-associated retrovirus (MSRV)-Env, a protein of endogenous retroviral origin expressed in MS lesions. The MSRV-Env protein is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation (oligodendrocytes are the cells producing myelin, the protective sheath around neurons that is degraded in MS).

The Phase 2b trial will be a randomized, double-blind, placebo-controlled and dose-escalation study followed by a six-month open-label phase to test GNbAC1 in RRMS patients. The study aims to assess the clinical benefit of GNbAC1 in neutralizing the MSRV-Env protein, identified as a potential key factor fueling the inflammatory and neurodegenerative components of MS. The assessment of GNbAC1’s efficacy will be based on the analysis of multiple brain magnetic resonance imaging (MRI) scans. Preliminary data are anticipated for the end of 2017.

The company also announced that Servier, its partner in developing GNbAC1, has exercised its equity investment option under a November 2014 agreement to become a minority shareholder in GeNeuro (acquiring shares from Eclosion). Under the terms of the agreement, Servier will pay GeNeuro $40 million (€37.5 million) to complete the Phase 2b trial. Subject to exercising its option for a licensing agreement, Servier has agreed to finance the global Phase 3 development program and pay GeNeuro up to an additional $355 million (€325 million) in future development- and sales-related milestones, as well as royalties on sales.

“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,” said Jesús Martin-Garcia, CEO of GeNeuro, in a press release.

“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.

GeNeuro was created in 2006 by Eclosion, the Geneva life sciences accelerator, to be a spin-off of Institut Mérieux of France. The company develops first-in-class therapies against diseases associated with the expression of pathogenic proteins of human endogenous retroviral origin (HERV).

One comment

  1. Joanne Bowman says:

    I’ve been diagnosed with MS for a little over a year now but was being treated for Lupus since 1991. There have been so many things that have happened to me over the years from stroke like symptoms, tia’s, hoshimoto’s, chronic fatigue syndrome, Epstein Barr Virus, fibromyalgia, extreme fatigue, chronic muscle spasms, degenerative disc disease, rheumatoid arthritis, pulmonary embolism, chronic vitamin D deficiency, memory loss/cognitive issues and depression/anxiety. I’ve been told I don’t have Lupus by two very good Rheumatologist, and have been told I’ve probably had MSthis whole time. For nine months I was on Tecfidera, and then had an allergic reaction (Angioadema), lips & mouth, but was also on Vesicare for only a couple of months (I think this was the culprit), but they took me off both medications and am currently taking 40mg., Copaxone and I don’t feel as good as I did when I was on the Tecfidera. I do water therapy 3 days a week and it does make me feel good, but not as good as when I was on the Tecfidera. I have a twin sister,that was diagnosed with MS (fraternal) and now the oldest of my two daughters age 31 was diagnosed with MS 2 months ago and currently also taking Copaxone (same strength as I, both of us M-W-F’s. I also have a cousin (non-biological), my sister & I were adopted, and my dear mother in law has the progressive reoccurring MS, was on betaceron for 22 years but has recently been taken off this because her body is rejecting it. We are all from Michigan, (cousin and mother in law live in California and Arizona, but Michigan seems to be linked to many MS patients. I have one lesion at the base of my skull, and four more from cervical to lumbar, lumbar and cervical being the areas where degenerative disc disease is worst and muscle spasms as well. I use a cane for stability when I go anywhere that requires a lot of walking and a walker for days that my body hurts and is exhausted. My sister has several lesions in her brain, none in spine area, and my daughter has the same as me. My mother in law has lesions throughout her spine and is currently wheelchair ridden. I’m curious about the future of MS medications and the outlook to these drugs. Please keep me up to date on what your strides are and am interested in any medical trials.

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