Swiss-based, biopharmaceutical company GeNeuro has started treating patients in a Phase IIb trial of GNbAC1 for the treatment of relapsing-remitting multiple sclerosis (RRMS).
GNbAC1 is a monoclonal antibody designed to neutralise MSRV-Env protein, which is linked to the inflammatory and neurodegenerative components of multiple sclerosis (MS).
MS is an autoimmune disease affecting nearly 2.5 million people across the globe, according to the Multiple Sclerosis Foundation.
The double-blind, placebo-controlled, clinical trial assessing the herv-w env antagonist gnbac1 for efficacy in multiple sclerosis (CHANGE-MS) will enrol 260 patients in 69 clinical centres within 13 European countries.
The primary endpoint is to examine the cumulative number of active brain lesions determined by MRI after six months, followed by more MRI and clinical measures at 12 months.
Preliminary results of the trial are expected by the fourth quarter of next year.
GeNeuro chief operating officer Dr François Curtin said: "The aim of this Phase llb study is to demonstrate the efficacy of GNbAC1 as a treatment for MS patients.
"This new therapeutic approach, targeting MSRV-Env, seeks to neutralise 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 up a new therapeutic option for MS patients."
CHANGE-MS trial is fully funded through a partnership worth €362.5m and signed with Servier in 2014, in which Servier is involved in the development and potential commercialisation of GNbAC1 in MS in territories excluding the US and Japan.
GeNeuro CEO Jesús Martin-Garcia said: "Meeting this clinical milestone, the first since raising €33m in our IPO in Paris during April 2016, is an important step in the development of GNbAC1 in MS with Servier.
"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."