In Fight Against Alzheimer's, $100 Million Genentech Trial in Colombia May Be Ground Zero
April 27, 2015
By Alex Keown, BioSpace.com Breaking News Staff
COLOMBIA -- A $100 million Genentech study on Alzheimer’s treatment is focusing on members of a Colombian family who may carry a rare gene that leads to early onset dementia by age 45, the Wall Street Journal reported this morning. If the trials pan out, it could lead to the development of a drug that could treat the cause of Alzheimer’s disease, rather than help manage symptoms.
The study by San Francisco-based Genentech is researching the theory that a buildup of amyloid plaque in the brain is the main cause of Alzheimer's. So far, that theory has not been proven out, however, in March, Biogen Idec, Inc. ’s Alzheimer’s drug that targets amyloid plaque showed promise in early trials. According to news reports, the Biogen drug, aducanumab, led to reductions in brain amyloid. The plaque reduction was more pronounced as the dose of the drug increased and over time, Reuters reported. Biogen is looking to begin a Phase III trial, which if it proves successful, would then lead the company to seek approval to market the drug.
Genentech’s Colombian trial involves approximately 300 people, with about 200 being suspected of carrying the rare gene. Half of those 200 will receive the anti-amyloid injection, and half will receive a placebo. The remaining 100 are non-carriers who will receive a placebo, the Journal reported. Final results from the trial won’t be known until about 2020, when the last test participant has completed five years of testing. However, an interim analysis is expected to be completed and published prior to that date.
In the Colombia trial, researchers told the Journal they can deliver better results by starting treatment earlier —“before the onset of symptoms and severe damage to the brain in people who would otherwise be certain to get the disease.”
The early-onset form of Alzheimer's seen among residents in the area of Colombia where the rare gene seems more common makes up less than 2 percent of Alzheimer's cases world-wide, according to the article. Alzheimer's disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total there are about 50 million people suffering from some form of dementia worldwide.
Following Biogen’ successful data, Roche researchers said they were more confident in their drugs targeting the plaque. They said they would take another look at two experimental drugs that suffered setbacks in2014. Last the company said gantenerumab was not proving effective. Likewise, Roche reported in July that renezumab, another Alzheimer’s drug in clinical trials, failed to help people with mild to moderate Alzheimer’s.
There are several drugs on the market that help manage Alzheimer’s, but none treat the primary cause. According to a Bloomberg report, there have been more than 100 failed efforts to develop a treatment for Alzheimer’s disease since 1998. In addition to Roche’s two failed drugs, pharmaceutical giants Eli Lilly and Company and Pfizer Inc. have also reported setbacks with their experimental Alzheimer’s treatments. Eli Lilly does have another experimental drug in Phase III trials with results expected sometime in 2016. Lilly’s solanezumab targets the amyloid plaque.
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