Servier and Geneuro to present six-month results from CHANGE-MS phase 2b study in multiple sclerosis at MSParis2017
Top line efficacy and safety data on primary and secondary endpoints previously announced on August 28, 2017
Presentation of results and post-hoc analyses supporting the hypothesis of a delayed onset of action of GNbAC1 as well as target engagement in the central nervous system
September 19, 2017 – Servier and GeNeuro (Euronext Paris: CH0308403085 – GNRO) announced today that 6-month data from the CHANGE-MS Phase 2b study will be presented at MSParis2017, the 7th Joint ECTRIMS-ACTRIMS meeting held 25-28 October 2017, in Paris, France. The presentation will cover efficacy and safety data, and will include post-hoc analyses supporting the hypothesis of a delayed onset of action of GNbAC1 as well as target engagement in the central nervous system.
What: 6-month efficacy and safety data from CHANGE-MSWho: Prof. Hans-Peter Hartung, chairman of the Department of Neurology of the University Hospital Düsseldorf and principal investigator of the CHANGE-MS study
When: Saturday, October 28 at 09:30 am, in the Late Breaking News session
Further details will be communicated right after the conference.
CHANGE-MS is an international, randomized, double-blind, placebo-controlled study of 270 RRMS patients, investigating GNbAC1 for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). GNbAC1 is a monoclonal antibody which neutralizes a retroviral envelope protein encoded by a pathogenic member of the HERV-W family (pHERV-W env).
(Clinical trial assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in Multiple Sclerosis)
- Randomized, double-blind, placebo-controlled study of 270 RRMS patients in 50 clinical centers in 12 European countries
- 6-month study with extension up to one year for secondary endpoints
- Primary endpoint: assess the efficacy based on the number of inflammatory lesions on brain MRI, assessed at the end of the placebo-controlled period
- Secondary endpoints: MRI measures of neurodegeneration, clinical parameters at 6 and 12 months, and biomarkers, including pHERV-W env
CHANGE-MS is fully funded through a partnership with Servier signed in 2014, in which Servier is involved in the development and potential commercialization of GNbAC1 in MS in territories ex USA and Japan. Under this agreement and depending on achievement of development milestones, GeNeuro could receive a maximum of €362.5M, excluding royalties.
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. Researchers have demonstrated that the retroviral envelope protein associated with a pathogenic form of HERV-W [pHERV-W, formerly referred to as the Multiple Sclerosis RetroVirus (MSRV)] has been identified in brain lesions of patients with MS, particularly in active lesions, and in the pancreas of T1D patients. By neutralizing pHERV-W env, GNbAC1 could at the same time block these 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 directly affecting the patient’s immune system, as observed in all clinical trials to date.
GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis and Type 1 diabetes, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA.
GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has 30 employees and rights to 16 patent families protecting its technology.
For more information, visit: www.geneuro.com
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover
(excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric disease, oncology and diabetes, as well as by its activities in high-quality generic drugs.
Servier has a solid commitment to neuropsychiatry and to proposing innovative therapies to patients suffering from neurological conditions. Its research teams are investigating new ways of treating diseases such as Alzheimer’s and Parkinson’s, as well as a broad range of neurodegenerative disorders, by targeting the toxic proteins that lead to neuron degeneration. The priority is to focus on the causes of the diseases rather than their symptoms. Currently, there are 5 projects at different stages of research in this promising area. Regarding development, where Servier’s team has a strong expertise in international clinical development and in investigator training in neurology and psychiatry, current phase II/III projects focus on autism, major depressive disorder, post-stroke functional recovery and multiple sclerosis.
For more information, visit: www.servier.com
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