ANGEL-MS extension study will offer the 260 patients enrolled in the on-going Phase IIb CHANGE-MS study the opportunity to continue their treatment for an additional two years and will provide additional efficacy and tolerance data
GeNeuro, a biopharmaceutical company developing new treatments for autoimmune diseases, including multiple sclerosis, and Servier, a leading independent international pharmaceutical company, announce the setting-up of ANGEL-MS, a long-term extension study for patients with multiple sclerosis (MS) and treated with GNbAC1.
GNbAC1, developed by GeNeuro, is the first drug candidate directly targeting a potential cause of MS. GNbAC1 is a monoclonal antibody designed to neutralise MSRV-Env, a toxic protein potentially associated with the inflammatory and neurodegenerative components of the disease.
To collect long-term data on this new treatment, particularly on its tolerance, the durability of its effect and the patients’ quality of life, GeNeuro and Servier have decided to set up an the ANGEL-MS (Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an open label Long-term Safety Study in patient with Multiple Sclerosis) study, which is an extension of the CHANGE-MS study currently under way.
ANGEL-MS will give patients an opportunity to continue their treatment. This study is expected to last two years and will start in April 2017, once the first patient included in the CHANGE-MS study will have completed the 12-month participation. GeNeuro is the study sponsor, and as with CHANGE-MS, the ANGEL-MS study will be fully funded by Servier.
As per the terms of its partnership signed with GeNeuro in 2014, Servier is funding the European, double-blind, and placebo-controlled clinical study on GNbAC1 CHANGE-MS (Clinical trial assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in Multiple Sclerosis.
The primary endpoint of this 12-month study is the cumulative number of active brain lesions shown on an MRI at 6 months. The primary results after 6 months are expected in Q4 2017.
ANGEL-MS will be conducted in parallel with any Phase III studies that might be launched based on the results of the CHANGE-MS study.