SURESNES, France—A deal struck between Servier and the Swiss biotech firm GeNeuro will push forward the development of a drug that offers a new approach toward the treatment of multiple sclerosis (MS). Servier has agreed to fund the development and marketing of GeNeuro’s drug candidate GNbAC1 to target a protein believed to play a key role in causing MS.
“This drug offers a completely new way to treat MS,” GeNeuro CEO Francois Curtin tells DDNews. “GNbAC1 targets the protein MSRV-ENv, a factor that strong evidence shows to be a causal. This is the first treatment targeting this factor.”
Servier will provide GeNeuro $47 million for the completion of Phase 2b trials as the first stage in a deal that provides a framework for the global development and licensing of the drug. Following Phase 2b trials, Servier will have the option to license the drug in all markets except the United Staes and Japan. Servier will cover Phase 3 global development costs and pay GeNeuro up to $408 million in future development and sales milestones in addition to royalties on future sales. Servier will also have the option to take an equity stake in GeNeuro as a minority shareholder in the next 12 months.
“This agreement is an ideal way to develop GeNeuro’s technology and deliver its full value for patients and stakeholders,” says Jesús Martin-Garcia, GeNeuro chairman. “With all further development costs in MS funded by our partner, GeNeuro has a clear path forward with a manageable geographic focus on two of the world’s major markets.”
Unlike current treatments for MS, which focus on reducing the frequency of relapses, GeNeuro’s drug holds the potential to stop progression of the disease altogether. Most current treatments target the patient’s immune system, an approach that has limited effectiveness at slowing the progress of the disease and that can leave patients with an increased risk of infections and cancers. GNbAC1 instead targets MSRV-ENv, a protein that appears to be closely tied to the root causes of the disorder. MSRV-ENv is expressed in all active lesions of MS patients, and it both induces inflammation and blocks the remyelination process, which provides a protective mechanism for neurons. “Targeting this causal factor has the potential to stop disease progression,” Curtin says. “By blocking the MSRV-ENv target, the drug could act on the inflammatory and neurodegenerative components of all forms of MS.”
GNbAC1 could also be particularly well suited to treat the progressive forms of MS for which there is currently no approved treatment. About 40 percent of MS patients experience these forms of the disease, which are characterized by symptoms worsening over time. Current treatments only address the relapsing-remitting forms of MS.
GeNuero’s initial studies of GNbAC1 have revealed an attractive safety profile. An open-label extension of a Phase 2a safety study in 10 MS patients resulted in stability of brain lesions by MRI from baseline to 12 months, overall clinical stability and no signs of immunogenicity. Researchers also found a statistically significant decline of MSRV biomarkers in the blood during treatment. “This study, as well as a Phase 1 study in healthy individuals, showed that GNbAC1 was safe,” says Curtin. “These results are very promising.”
The Phase 2b trial of GNbAC1 that will be funded by Servier is expected to begin by the middle of 2015 and produce data by the end of 2017. This trial will involve 200 to 250 patients with a relapsing-remitting form of MS.
The global market for MS treatments currently sees $12 billion to $13 billion in annual sales, and GeNeuro estimates it will increase by 50 percent in the next 10 years. Although there is substantial competition, GNbAC1’s potential efficacy for progressive forms of MS and its attractive safety profile could help it stand out. “There is still a large unmet medical need and ample space for innovative treatments acting on the progression of the disease and allowing safe long-term treatment,” explains Curtin. “GNbAC1 should fulfill these requirements.”
GeNeuro was created in 2006 at Eclosion, the Geneva life-sciences accelerator, as a spin-off of Institut Mérieux. The company is primarily focused on the development of GNbAC1 as a treatment for MS. Olivier Laureau, president of Servier, says GeNuero makes an especially well-suited partner for his company. “Not only will this new strategic alliance allow Servier to enrich its portfolio in a disease with a huge unmet medical need, but we are especially proud to count as partner a company that was spun off from Institut Mérieux, a French institution internationally recognized for its excellence in research.”