Press releases

GeNeuro Announces First Patients Treated in Phase 2b Study for Multiple Sclerosis

Geneva, Switzerland, 31 May 2016 – GeNeuro (Euronext Paris: CH0308403085 – GNRO), a biopharmaceutical company developing new treatments for autoimmune diseases including multiple sclerosis (MS), today announced that the first patients have been treated with its lead product, GNbAC1, in a Phase IIb study in relapsing-remitting multiple sclerosis (RRMS).

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GNbAC1, the first drug candidate in clinical studies directly targeting a potential cause of MS, is a monoclonal antibody designed to neutralize MSRV-Env, a protein linked to the inflammatory and neurodegenerative components of the disease.

“The aim of this Phase 2b study is to demonstrate the efficacy of GNbAC1 as a treatment for MS patients. This new therapeutic approach, targeting MSRV-Env, seeks to neutralize an upstream source of inflammation and to restore the remyelination capacity of the brain,” explained François Curtin, MD, Chief Operating Officer at GeNeuro. “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.”

The double-blind, placebo-controlled study, CHANGE-MS (Clinical trial assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in Multiple Sclerosis) plans to enroll 260 patients in 69 clinical centers in 13 European countries. The primary endpoint will examine the cumulative number of active brain lesions determined by MRI after 6 months, followed by additional MRI and clinical measures at 12 months. Preliminary results are expected by fourth quarter 2017.

CHANGE-MS is fully funded through a €362.5 million1 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.

“Meeting this clinical milestone, the first since raising €33 million in our IPO in Paris in 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,” stated Jesús Martin-Garcia, CEO of GeNeuro.