A consortium formed to develop a new targeted drug against Alzheimer’s disease will receive €8.6 million ($11.3 million) from France’s state innovation agency Bpifrance, the effort’s initiator and leader said today.
AB Science said the effort, titled Role of Mast Cells in Neurology or ROMANE, will join the company with five partners that include the Brain and Spine Institute; Molecular Imaging Research Center or MIRCen, within France’s Atomic Energy Commission; the National Institute of Health and Medical Research or INSERM; Imagine Foundation; and Skuldtech, a biotechnology company specializing in discovery of biomarkers and development of companion diagnostics and testing tools.
ROMANE’s three goals are to validate the role of mast cells as a therapeutic target in Alzheimer's and other neurodegenerative diseases, develop AB Science’s drug candidate masitinib as a treatment for Alzheimer's, and propose new tools for diagnosis and monitoring of patients with the memory-robbing disease based on blood biomarkers and new imaging techniques.
Masitinib is a tyrosine kinase inhibitor designed to inhibit c-Kit and Lyn, two kinases specifically expressed in mast cells. As GEN reported last month, the road to a safe and effective Alzheimer’s drug has been littered with numerous failures compared with just five successes, all of which have simply slowed progression of symptoms for six to 12 months.
ROMANE includes AB Science’s already-launched Phase III trial to evaluate the safety and efficacy of two different doses of masitinib for patients with mild to moderate Alzheimer’s. In announcing the trial back in May, the company said the first patients for the study had been recruited in several countries for the trial, intended to evaluate the effect of masitinib after 24 weeks of treatment on cognition and memory, as well as on self-care and activities of daily living.
In the Phase III trial, masitinib will be given as an add-on therapy to patients treated at least six months with a stable dose of cholinesterase inhibitors (rivastigmine) and/or memantine, with no changes foreseen in therapy throughout the study. The Phase III study followed promising Phase II results linking masitinib with improvement in cognitive function and functional capacity compared to placebo, with an acceptable tolerance profile.
The funding from Bpifrance includes €5.9 million ($7.8 million) for AB Science itself in grants and repayable advances, the company said. The Bpifrance funds come from the agency’s Industrial Strategic Innovation program, which awards between €3 million (about $4 million) and €10 million ($13.2 million) in repayable advances and grants for collaborative innovative projects with an industrial purpose, run by small and medium-sized companies, and deemed both highly promising and unlikely to succeed without public support.