- Drugmakers have time and again fallen short with attempts to treat Alzheimer's disease by targeting a pair of proteins called tau and amyloid beta. Against that backdrop, Eisai is looking at a more genetic and immune system-centric approach to tackling the branch of neurodegenerative disorders that includes Alzheimer's disease.
- The Japanese pharma expects its Center for Genetics Guided Dementia Discovery, or G2D2, to open in the first quarter of 2019. As its name suggests, the center will use genetic information to discover new therapies that help regulate the neural inflammation which gives rise to dementia.
- Nadeem Sarwar, president of Eisai's Andover innovative Medicines (AiM) Institute, will helm the new initiative, and oversee around 70 employees working in areas such as data science and immuno-dementia biology. Once G2D2 is running, Eisai intends to shut down the AiM Institute. The drugmaker also aims to have a drug discovered at the center in the clinic by 2020.
Eisai acknowledged in the company's most recent annual filing that its R&D investments in Alzheimer's disease and oncology drugs have been "aggressive." During its fiscal year spanning April 2017 to March 2018, Eisai spent 140 billion yen (about $1.2 billion) on R&D — representing a nearly 20% bump from the prior fiscal year.
Money will continue to flow as Eisai works to get G2D2 off the ground.
The Japanese pharma said it would invest $100 million over the first three years to establish the center, noting funding could increase as development efforts progress. The financial commitment indicates Eisai isn't backing away from further investments despite the risky nature of Alzheimer's disease drug development.
High Point, North Carolina-based biotech vTv Therapeutics also discontinued development for its investigational therapy azeliragon in April when data from Part A of the Phase 3 STEADFAST program showed the drug didn't do better than placebo at mitigating cognitive decline. Notably, the company revealed Tuesday that Part B of the program also missed its co-primary efficacy endpoints.
The hope with each of these drugs from Merck, J&J and vTv was that they could help prevent the formation of amyloid plaques, a sticky conglomerate of proteins that research has shown impair neural function. Many of the therapies in the global pipeline for Alzheimer's disease and dementia focus on amyloid beta or a similar protein, tau, yet frequent failures in the clinic have spurred the industry to look elsewhere for potential treatments.
To that end, Eisai launched the AiM Institute in September 2016. There, the mission was to use precision medicine to discover new treatments in the areas of immuno-dementia, immuno-oncology and auto-immune disease.
G2D2 appears to be next step in Eisai's drug discovery evolution.
Along those lines, Eisai separately revealed Wednesday that the Japan Agency for Medical Research and Development (AMED) selected a research project between Eisai's KAN Research Institute and six joint research organizations for the agency's Cyclic Innovation for Clinical Empowerment (CiCLE) grant program. The industry-academia-government venture seeks to create a proprietary nucleic drug discovery platform.
The announcement comes less than a year after Eisai disclosed the AMED had selected another one of its projects — aimed at discovering novel drug target candidates that could give rise to next-generation and preventative therapies for dementia — for the CiCLE program.