Donanemab also showed improvements in prespecified secondary endpoints relative to placebo, but not all secondary endpoint findings were statistically significant.
The drug is an antibody which ultimately removes pieces of the Alzheimer's-related protein beta amyloid from the brain. Donanemab-treated patients showed an 84 centiloid reduction of amyloid plaque on average at 76 weeks, compared to a baseline of 108 centiloids.
Patients in the study stopped receiving donanemab and were switched to placebo once their brain plaques reached levels seen in healthy people - a process that took just a few months for some patients.
"This unique mechanism and antibody for clearing plaques, discovered at Lilly, has the potential to provide high levels of durable amyloid plaque clearance after limited duration dosing", said Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories.
The results also "tell us that there are other things at play", he added, saying additional strategies were needed to fully combat Alzheimer's.
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The safety profile of donanemab was consistent with observations from Phase 1 data. Amyloid-related imaging abnormalities (ARIA) were observed, which is consistent with amyloid plaque clearing antibodies.
A brain swelling side effect, known as ARIA-E, occurred in 27% of patients treated with donanemab, Lilly said.
In the "amyloid theory", high levels of amyloid plaques are believed to be associated with Alzheimer's disease and there is speculation that early intervention to prevent its development could benefit people with Alzheimer's.
Lilly said it would present the TRAILBLAZER-ALZ study's full results at a future medical congress and publish them in a clinical journal. Lilly plans to discuss these results with regulators to assess next steps for donanemab.
"We are extremely pleased about these positive findings for donanemab as a potential therapy for people living with Alzheimer's disease, the only leading cause of death without a treatment that slows disease progression", stated Mark Mintun, MD, Lilly's vice president of pain and neurodegeneration. We look forward to discussing the TRAILBLAZER-ALZ study data and next steps with global regulators.
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"In addition, we are committed to reproducing and extending these important findings in our second ongoing pivotal donanemab trial, TRAILBLAZER-ALZ 2".
The announcement touched off a stock surge for Lilly, which saw its share price climb 13% in response to the news, rising to $188.59 as of 9:36 a.m. before dipping to 185.43 from Friday's close of $166.41, an 11% gain.
However, this theory has been tried and tried again, with a string of failures in the field that includes Lilly's previous Alzheimer's candidate solanezumab. The drug met a main objective to slow decline in about 18 months.
Over many years, multiple beta amyloid-targeting drugs have failed in clinical trials.
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The next highest country is the Czech Republic (Czechia), which is reporting around 121 cases per capita each day. The COVID-19 Dashboard provides up-to-date information on the key indicators of COVID-19 in the community.