The decision came after Servier, a European company which, together with GeNeuro, developed the GNbAC1 program, declined to continue developing the therapy due to strategic reasons, research and development, and other development priorities.
GeNeuro already had full rights in the U.S. and Japan markets, and will continue to receive the support of Servier as a shareholder.
GNbAC1 is a humanized IgG4 antibody designed to block a protein made by a retroviral gene. Human endogenous retroviruses (HERVs) are ancient viruses that incorporate their DNA into the human genome. Researchers believe that retroviral sequences comprise up to 8 percent of the human genome.
Growing evidence suggests that activating HERVs contributes to inflammatory processes and diseases like MS. In fact, a protein known as pHERV-W Env is commonly present in inflammation patches known as lesions in MS patients’ brains and in their blood.
GNbAC1 blocks the pHERV-W Env protein’s pro-inflammatory effects and promotes remyelination (the formation of myelin, the protective coat surrounding neurons that is destroyed in MS).
In the Phase 2b CHANGE-MS study (NCT02782858), researchers looked at GNbAC1’s effectiveness in 270 patients ages 18-55 with relapsing-remitting MS (RRMS). Patients were randomly assigned to one of three doses of GNbAC1 or a placebo, delivered as monthly intravenous infusions.
A recent analysis performed at 12 months showed that the highest dose of GNbAC1 (18 mg/kg) carried a significant neuroprotective effect against brain shrinkage (atrophy). Whole brain atrophy was reduced by 29 percent compared to the control group, as shown by magnetic resonance imaging (MRI).
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