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).
The highest dose of GNbAC1 also reduced the burden of T1 hypointense lesions — a hallmark of permanent tissue destruction in the brain — by 63 percent compared to controls.
Researchers also evaluated if GNbAC1 improved a measure of brain abnormality known as magnetization transfer ratio (MTR) in areas with new lesions. Compared to placebo controls, the MTR remained stable in agreement with the therapy’s potential for promoting remyelination (a decrease in MTR is associated with myelin loss and nerve cell death).
Overall, the therapy was found to be well tolerated without any organ-specific toxicity and no dose dependent adverse effects.
Based on these positive results, GeNeuro will pursue the development of GNbAC1 and options for partnering.
“We understand this is a strategic decision for Servier, which we respect. It opens new opportunities for GeNeuro at this stage of our development,” Jesús Martin-Garcia, CEO of GeNeuro, said in a press release.
“Based on our successful results on key measures linked to MS progression, we will continue to work to form new partnerships to bring the benefits of GNbAC1 to patients,” Martin-Garcia added.
Emmanuel Canet, executive vice president of research and development at Servier, added that “based on R&D strategic reasons, Servier has made the difficult choice to decline the option to license GeNeuro’s compound in MS. We were glad to work with GeNeuro harmoniously, and are proud to have contributed to the development of a new approach to treat disease progression, the major unmet medical need in MS.
“We are extremely grateful to all patients who participated in this development. GeNeuro has strong leadership and development capabilities. Servier believes in the potential of this approach and will continue to support the company as a shareholder,” Canet said.