Eli Lilly, a 140-year-old pharmaceutical company, presents new positive data bolstering its claim on its experimental Alzheimer's therapy that claims to slow down the disease during its early-stages, which top company scientists sat could attribute to a successful drug.
Additionally, Dr. Danial Skocronsky states that the trial validates the once-battered amyloid hypothesis--a theory that served as a foundation for various disappointing Alzheimer's drugs.
If other researchers agree, the trials' results could significantly impact Eli Lilly and other companies currently developing Alzheimer's treatments, such as Biogen.
Eli Lily's Alzheimer's Therapy
In January 2020, Eli Lily published top-line data from its Phase 2 trials showing a monoclonal antibody--donanemab-- that slowed the progression of Alzheimer's disease by 32% in early-stage patients.
The new data released shows that the slowing of Alzheimer's progression in its initial results was mirrored for various disease progression measures, which matched multiple timepoints across Eli Lily trials. The consistency will most likely provide investors more confidence in the pharmaceutical company's experimental drug's efficacy.
Skovronsky, Eli Lily's chief scientific officer, tells Barron's that the team heavily scrutinized the data. Cut in different ways to locate any anomalies; the results only showed the drug's success different from every study on Alzheimer's published today.
In addition, the new data shows the rapid and dramatic clearing of amyloid plaque--proteins that scientists believe play a role in causing Alzheimer's disease. An exploratory analysis showed a significant decrease in tau load--protein tangles associated with Alzheimer's disease in specific regions of the brain.
The notion that the proteins cause the diseases is based on the so-called amyloid hypothesis, a controversial theory that has been met with increasing skepticism after numerous drugs based on the theory have failed to work.
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Donanemab: Eli Lilly's Revolutionary Findings
Skovronsky reiterates that the new detailed data published in The New England Journal of Medicine entitled "Donanemab in Early Alzheimer's Disease" is the best clinical evidence for the amyloid theory.
He explains that once the amyloid plaque is clearly, deeply, and quickly removed, the progression of tau pathology and cognitive decline is slowed, coinciding with the amyloid hypothesis's predictions.
Of the participants of the clinical trials of donanemab, 40% reached 'amyloid negative' levels after only 24 weeks or the clearance of amyloid plaques at 68% after 76 weeks.
Skovronsky explains that donanemab had shown more efficacy in reducing amyloid plaques 24 weeks than other drugs accomplished in 18-month trials.
Researchers explain that the antibody, donanemab, only does one thing---clear amyloid plaques. And in the absence of plaques, tau pathology neither spread nor reverses, leading to cognitive changes.
The slow down of cognitive and functional decline measured by CRD-SB, a secondary measure of cognitive performance in Alzheimer's patients used in Eli Lilly's study, came in at 23%.
Eli Lilly runs the second Phase 2 donanemab trials to replicate the initial trials' results.
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