First MS Patients in CHANGE-MS Trial Receive Novel Treatment

GeNeuro, a biopharmaceutical company that focuses on novel treatments for autoimmune diseases such as multiple sclerosis (MS), announced that the first patients with relapsing-remitting multiple sclerosis (RRMS) are under treatment with the company’s leading drug, GNbAC1, in a Phase 2b clinical trial.

GNbAC1 is a monoclonal antibody designed to neutralize MSRV-En, a protein previously linked to both inflammation and neurodegenaration features of MS.

In the double-blind, placebo-controlled study CHANGE-MS (Clinical trial assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in Multiple Sclerosis), scientists plan to enroll 260 patients within 69 clinical centers across 13 European countries. The study aims to assess the cumulative number of active brain lesions (examined by magnetic resonance imaging, MRI) at six and 12 months of treatment and compared it to placebo controls. The study’s preliminary results are due in 2017.

“This new therapeutic approach, targeting MSRV-Env, seeks to neutralize an upstream source of inflammation and to restore the remyelination capacity of the brain. Blocking a causal factor in MS, as opposed to current treatments that interfere with the immune system, would open a new therapeutic option for MS patients,” said Dr. François Curtin, chief operating officer at GeNeuro, in a press release.

Jesús Martin-Garcia, CEO of GeNeuro, said meeting the clinical milestone is an important step in the development of GNbAC1 in MS with Servier, an independent French-based pharmaceutical company pursuing innovative treatments in several diseases, including cancer and cardiovascular, metabolic, central nervous system, psychiatric, bone, muscle and joint diseases.

“The successful IPO will now allow GeNeuro to extend MS studies of GNbAC1 into the US, where GeNeuro has kept all the rights, and initiate trials in other autoimmune diseases, including type-1 diabetes and CIDP (chronic inflammatory demyelinating polyneuropathy), an orphan neurological disease,” Martin-Garcia said.

CHANGE-MS is fully funded by a partnership between GeNeuro and Servier.  Servier is set to develop and commercialize GNbAC1 in MS throughout the world.