No anti-inflammatory effect with GeNeuro’s/Servier’s multiple sclerosis drug at 6 months

GeNeuro and Servier on Monday said that GNbAC1, for the treatment of certain multiple sclerosis was well tolerated, without statistical difference at 6-months between it and placebo, with the study’s mail goal to reduce the number of cerebbral Gad-enhancing lesions.

The companies on announced the half year results from the 12-month CHANGE-MS Phase 2b study of three doses of GNbAC1 for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).

The study’s primary endpoint was to reduce the number of cerebral Gad-enhancing lesions as measured by MRI, nor on the other MRI measures of neuroinflammation. Relapses in the overall population decreased by over 50% relative to the year prior to study but there was no significant difference at 6 months between treated and placebo groups. Based on the unique mechanism of action and pharmacokinetics of GNbAC1, the study will continue, as planned, exploring potential benefits of the drug on MRI and clinical measures, including remyelination properties, with final results from the full 12-month expected in the first quarter of 2018.

GeNeuro and Servier’s CHANGE-MS Phase 2b study is a randomized, double-blind, placebo-controlled study of 270 RRMS patients in 50 clinical centers in 12 European countries. The primary endpoint at 6 months is an assessment of the efficacy of GNbAC1 based on the number of inflammatory lesions on brain MRI. Secondary endpoints at 12 months will also include MRI measures of neurodegeneration, clinical parameters, and biomarkers, including pathogenic pHERV-W env. The protein could be a causal factor in the development of multiple sclerosis, the companies said.

CHANGE-MS is fully funded through a 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. Under this agreement and depending on achievement of development milestones, GeNeuro could receive a maximum of €362.5M, excluding royalties.

“CHANGE-MS being a study evaluating an innovative approach not immunosuppressive in MS, a longer delay of action than seen with other drugs is possible. The 6-month data showed a good safety profile. From a clinical perspective, it is important to wait for the full 12-month results,” noted Prof Hans-Peter Hartung, chairman of the Department of Neurology of the University Hospital Düsseldorf and principal investigator of the CHANGE-MS study.

Dr. Christian de Bodinat, Director of Servier’s Neuro-psychiatry Therapeutic Innovation Pole, said: “In line with Servier’s commitment to bringing new safe and effective treatments to patients, we will continue working with GeNeuro to better understand the potential clinical benefits of this innovative drug, GNbAC1, and wait for the full results of the study at 12 months.” 

Jesús Martin-Garcia, CEO of GeNeuro, said that GNbAC1 is a new way to treat MS patients, with a novel mode of action. He said that the analysis of the data is ongoing to better understand potential therapeutic benefits. “We are fully committed to this technology and look forward to final results from this 12-month study, expected in the first quarter of 2018,” said Martin-Harcia.

GNbAC1 is a monoclonal antibody which aims at neutralizing a retroviral pathogenic envelope protein (pHERV-W env) encoded by a member of the HERV-W family. Human endogenous retroviruses (HERVs) are ancestral retroviral DNA insertions in the human genome, thought to account for up to 8% of the human genome. The pHERV-W env protein is thought to be a causal factor in the development of multiple sclerosis and Type 1 diabetes. GeNeuro is currently conducting a Phase 2a study in Type 1 diabetes, with results expected during the third quarter of 2018.