Courier Advances Phase 3 Trial of Alzheimer's Disease Antibody Therapy, Eli Lilly Reaches Strategic Cooperation

▎WuXi AppTec content team editor July 15, 2021, Eli Lilly and Company and Banner Alzheimer's Institute announced a strategic research cooperation agreement to promote Eli Lilly’s Phase 3 clinical trials conducted
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The randomized, double-blind, placebo-controlled Phase 3 clinical trial TRAILBLAZER-ALZ 3 will evaluate the Lilly's research antibody therapy donanemab to slow Alzheimer's in patients at risk of cognitive and functional decline associated with Alzheimer's disease The possibility of clinical progression of silent disease, regardless of whether the subject carries the APOE4 gene
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The trial plans to start enrollment later this year
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In this collaboration, Banner will use its expertise in Alzheimer's disease prevention trials and support the enrollment of subjects through its Alzheimer's Disease Prevention Registry's GeneMatch project
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The collaboration will introduce a virtual method to evaluate preventive treatments for Alzheimer's disease
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Both Eli Lilly and Banner are committed to using screening and treatment data as shared scientific resources
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Beta amyloid deposition is one of the important pathological features of Alzheimer's disease
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As an investigational monoclonal antibody therapy, Donanemab targets a beta amyloid subtype called "N3pG"
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It can bind to beta amyloid in the amyloid deposits in the brains of AD patients, thereby speeding up the removal of amyloid deposits in the brains of patients
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In June of this year, Donanemab was granted a breakthrough therapy designation by the US FDA for the treatment of Alzheimer's disease
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▲Donanemab is designed to specifically combine with amyloid deposits in the brain to promote their elimination (location marked in red box, picture source: reference [3]) The latest phase 2 clinical trial of this drug has reached the trial The primary end point of patients receiving donanemab, the reduction in Alzheimer’s Disease Scale (iADRS) scores was 32% less than that in the placebo group (p=0.
04), which means that patients’ cognition and ability of daily living The rate of decline has been eased
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At the same time, positron scanning (PET) imaging showed that donanemab can quickly remove amyloid deposits in the brains of patients.
After 6 months of treatment, 40% of patients had a negative PET test, which means they had amyloid deposits in their brains.
There is no significant difference between the level of health and healthy people
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Alzheimer's disease is a fatal neurodegenerative disease that causes a progressive decline in patients' memory and other cognitive aspects
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In addition to age and family history of the disease, the APOE4 allele is the largest genetic risk factor for Alzheimer's disease
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Previous studies have shown that compared with low-risk people who carry two APOE3 alleles, if ordinary people carry one APOE4 gene, they can increase the risk of Alzheimer's disease by about three times.
If they carry two APOE4 genes, the risk is even higher.
It is to soar to 8-12 times
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In addition, compared with people carrying the APOE2 or APOE3 gene, people carrying the APOE4 allele are more likely to develop β-amyloid deposits at a younger age
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"This collaboration combines Lilly's 30 years of experience in Alzheimer's disease research with Banner's unique expertise to find potential treatments to end this devastating disease
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"Lilly’s Pain and Neurodegeneratives Division Vice President Dr.
Mark Mintun said, "Our TRAILBLAZER-ALZ 3 trial will evaluate whether donanemab can prevent patients who have pathological evidence of Alzheimer’s disease but have not yet demonstrated clinical symptoms.
Clinical progress
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"Reference: [1] Lilly and Banner Alzheimer's Institute collaborate on planned Phase 3 prevention trial of donanemab.
Retrieved July 15, 2021, from https://investor.
lilly.
com/news-releases/news-release-details/lilly -and-banner-alzheimers-institute-collaborate-planned-phase Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
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