Washington University School of Medicine in St. Louis has pieced together a pioneering new study that will help put a new theory on preventing Alzheimer's to a definitive test. And the outcome could help pave the way for a megablockbuster approach to treating a disease that afflicts millions.
Investigators have arranged a free supply of two drugs from Lilly ($LLY)--including its controversial late-stage drug solanezumab--along with gantenerumab, Roche's ($RHHBY) most advanced Alzheimer's drug now in a pivotal trial. An NIH-funded consortium of Alzheimer's research centers working in collaboration with a pharma-backed team of companies which has been advising on the study will recruit patients genetically inclined to develop Alzheimer's for the long-term study.
In addition to the two late-stage drugs, the team will test a small molecule, beta-secretase inhibitor now in Phase II which is also being supplied by Lilly. The first phase of the study, which begins early next year, will run for two years. Investigators will continue to provide any drugs that prove promising in that first stage.
The failure of bapineuzumab and solanezumab in two high-profile Phase III studies this year has helped drive a fundamental shift in Alzheimer's research. Instead of targeting patients with a developed case of the disease, whose brains are already damaged, investigators are moving toward high-risk populations in an attempt to determine whether preventing toxic levels of beta amyloid from building up in the brain can delay or prevent the disease. The rethink has helped inspire another groundbreaking study in which Roche's crenezumab – an antibody licensed from Switzerland's AC Immune--is being tested in Colombia among a clan known for high rates of the memory-wasting disease.
"Trying to prevent Alzheimer's symptoms from ever occurring is a new strategy," says John C. Morris, M.D., principal investigator of DIAN and the Harvey A. and Doris Friedman Distinguished Professor of Neurology at the School of Medicine. "We are most appreciative of the support this approach has received."
If it works, the market for this drug would be huge. But no one will know for some time to come.