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ARTICLE | Clinical News

GeNeuro reports 12-month Phase IIb data for RRMS candidate

March 30, 2018 5:15 PM UTC

GeNeuro S.A. (Euronext:GNRO) and Servier (Suresnes, France) reported 12-month data from the double-blind, European Phase IIb CHANGE-MS trial in 270 patients with relapsing-remitting multiple sclerosis (RRMS). Patients received placebo or one of three doses of once-monthly IV GNbAC1 for six months, after which patients in the placebo arm switched to GNbAC1 for the second six-month period.

Patients who received once-monthly 18 mg GNbAC1 -- the highest dose tested -- for 12 months had relative volume loss reductions of 31% in cortical atrophy and 72% in thalamic atrophy compared with the control group of patients who received placebo for six months before switching to GNbAC1 for six months (p=0.045 and p=0.014, respectively). The once-monthly 18 mg/kg dose of GNbAC1 also led to a 29% relative reduction in whole brain atrophy over 12 months vs. the control group (p=0.079). Furthermore, high-dose GNbAC1 reduced the number of T1 hypointense lesions of ≥14 mm3 in volume by 63% at 12 months vs. the control group (p=0.014)...