‘It Was Really Crushing’: Promising Alzheimer’s Drug Fails To Deliver In Just Latest In String Of Devastating Disappointments
The results of the five-year study may not be a knock-out punch for the treatment, though. The drugs did not work, but the problems may be fixable: perhaps the doses were too low, or they should have been given to patients much younger. However, the set-back was a disappointment in a field that has had more than its fair share of them.
Two experimental drugs failed to prevent or slow mental decline in a study of people who are virtually destined to develop Alzheimer's disease at a relatively young age because they inherited rare gene flaws. The results announced Monday are another disappointment for the approach that scientists have focused on for years -- trying to remove a harmful protein that builds up in the brains of people with Alzheimer's, the leading cause of dementia. (Marchione, 2/10)
For five years, on average, the volunteers received monthly infusions or injections of one of two experimental drugs, along with annual blood tests, brain scans, spinal taps and cognitive tests. Now, the verdict is in: The drugs did nothing to slow or stop cognitive decline in these subjects, dashing the hopes of scientists. Dr. Randall Bateman, a neurologist at Washington University in St. Louis and principal investigator of the study, said he was 鈥渟hocked鈥 when he first saw the data: 鈥淚t was really crushing.鈥 (Kolata, 2/10)
The Lilly and Roche drugs are designed to work by reducing a sticky substance called beta amyloid that builds up in the brains of Alzheimer鈥檚 patients. Lilly and Roche have previously tested their drugs in clinical trials of patients with the more common form of Alzheimer鈥檚 that typically affects people 65 and older. Lilly鈥檚 drug failed to significantly help patients and Roche halted two studies of its drug after concluding it wouldn鈥檛 help. Lilly said it won鈥檛 pursue an application for regulatory approval of solanezumab to treat dominantly inherited Alzheimer鈥檚. (Loftus, 2/10)
The focus quickly shifted to Biogen (BIIB), which made global headlines last year after claiming a controversial victory with an amyloid-targeting therapy of its own. With that treatment expected to undergo Food and Drug Administration review this year, do the results from Lilly and Roche poke holes Biogen鈥檚 case for approval? There鈥檚 a compelling argument to be made.聽(Garde, 2/10)