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Eli Lilly's Alzheimer's disease drug fails in final-stage trial

Eli Lilly's Alzheimer's disease drug fails in final-stage trial

Eli Lilly shares subsequently dropped 14 percent in premarket trading.

Eli Lilly has announced that its anti-amyloid agent solanezumab failed to slow cognitive decline in people with mild dementia in a phase 3 trial. Lilly said that solanezumab results were " directionally" favorable, they were not enough to justify seeking regulatory approval.

The failure of Eli Lilly and Co's Alzheimer's treatment to slow declines in mental capacity of patients with even mild symptoms cast serious doubt over whether a long-held approach to the memory-robbing disease could provide meaningful benefit to millions of people at risk. "We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets", Dr Lechleiter said. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. "We don't know the answer". Current Alzheimer's treatments like Aricept and Namenda only temporarily ease symptoms such as memory loss, confusion and agitation.

The drug, solanezumab, missed the study's main goal when patients taking it did not experience a statistically significant slowing of cognitive decline — which involves a person's ability to remember things — compared to those taking a placebo or fake drug. The company has a BACE inhibitor of its own in late-stage development in partnership with AstraZeneca, and it's progressing a handful of early-stage therapies aimed at other Alzheimer's targets.

Incoming CEO David Ricks told "Squawk Box" that Lilly had been planning for this worst-case scenario, and still expects to grow without the drug. Solanezumab is created to sweep away plaques called beta-amyloids, which build up in the brains of patients with Alzheimer's.

In all, Biogen is conducting clinical trials on three Alzheimer's compounds and is about to move two others into trials.

After that, Biogen is slated to disclose late-stage data on an amyloid antibody that scientists and Wall Street analysts say could be the most promising treatment in its class.

Merck is now leading in the BACE inhibitor race with its product verubecestat, which is being tested in two late-stage Phase III trials, the first of which is expected to report results next year.

"While today's results are a setback for the amyloid hypothesis, there are several other anti-amyloid drugs still in clinical trials that work in different ways, some of which are being tested even earlier in the disease process than solanezumab". In the pre-market hours Wednesday, shares fell 15 percent to $64.65. So it began another trial using 2,100 patients with low dementia brought about by Alzheimer's.

Unlike previous trials with the drug, EXPEDITION 3 used amyloid PET brain scans or spinal fluid tests to select only those patients with high levels amyloid who were most likely to respond to the drug. The drug binds the bloodstream to a beta amyloid, a protein that is believed to cause toxic brain plaques.