Dive Brief:
- Swiss biotech GeNeuro SA and partner Servier announced this weekend the results of a post-hoc analysis of six-month data from its CHANGE-MS Phase 2b study in patients with relapsing-remitting multiple sclerosis (RRMS).
- The analysis, announced at the MSParis17 conference, showed an anti-inflammatory effect and potential remyelination effect at 24 weeks for patients on the highest dose of GNbAC1. This analysis was contrary to previous results from the total patient population in the study.
- The biotech's stock shot up 38% to trade above €7 per share on the Euronext Paris exchange midday Monday Paris time.
Dive Insight:
The analysis was conducted on 121 patients — about 45% of those enrolled in the study — that showed evidence of at least one gadolinium-enhancing (Gd+) T1 lesion on their initial brain MRI scan. The six-month analysis showed a reduction of these legions for patients taking the 18 mg/kg dose, the highest dose level in the study.
GeNeuro and Servier claim this analysis shows a late onset of action for GNbAC1 that does not occur until after six months, arguing that it takes nearly that long for enough drug to build up in the brain to show an effect.
Remyelination, the process of creating new myelin sheaths around axons in the central nervous system, was measured by MRI with magnetic transfer ratio (MTR). Research has shown that the MTR signal decreases when measured in patients with multiple sclerosis. GeNeuro says those patients taking the highest dose of GNbAC1 showed an increase in the MTR signal, while other patients in the study showed either no change or decrease in the MTR signal.
"The effect of GNbAC1 on inflammation and remyelination observations for the highest dose at Week 24 are very encouraging," explained Hans-Peter Hartung, lead investigator and presenter of the study. "This is a novel mechanism of action trying to block a potential cause of the disease, so these analyses help us understand how GNbAC1 works in the patient setting and what benefits it could bring to patients. We now look forward to confirmation at the 48-week readout."
Earlier this summer, the partners announced disappointing results from the six-month data of the study, showing it did not demonstrate an anti-inflammatory effect. The new analysis presented at MSParis17 was an attempt by the company to redeem itself and show that GNbAC1 still has promise when given at the right dose and for a long enough period of time.
GeNeuro and Servier linked up in December 2014 in a deal worth $455 million that promises the French company ex-U.S. and Japanese rights to the multiple sclerosis drug.