Breaking New Ground in Alzheimer’s Treatment: A Deep Dive into Lilly’s Kisunla? (Donanemab-azbt) FDA Approval

Breaking New Ground in Alzheimer’s Treatment: A Deep Dive into Lilly’s Kisunla? (Donanemab-azbt) FDA Approval

The recent FDA approval of Lilly’s Kisunla? (donanemab-azbt) for early symptomatic Alzheimer’s disease marks a monumental breakthrough in combating this debilitating condition. As we celebrate this achievement, it’s crucial to explore its implications and highlight how our innovative humanized mouse models contribute to advancing Alzheimer’s research.

Kisunla? targets the amyloid plaques that accumulate in the brains of Alzheimer’s patients. By promoting the clearance of these plaques, donanemab-azbt potentially slows cognitive decline, offering new hope to patients and emphasizing the importance of innovative research and development.

Understanding Alzheimer’s Disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder affecting millions worldwide. Characterized by memory loss, cognitive decline, and behavioral changes, AD is identified by the accumulation of amyloid plaques and tau tangles in the brain, disrupting neuronal function and leading to cell death.

The approval of Kisunla? underscores the progress being made in Alzheimer’s research, highlighting the importance of targeting amyloid pathology and validating advanced preclinical models in drug development. As researchers explore new treatment avenues, robust models like those provided by Biocytogen become increasingly significant.

Biocytogen Alzheimer’s Disease Models

Biocytogen is at the forefront of Alzheimer’s research, providing state-of-the-art humanized mouse models that are crucial for understanding disease mechanisms and evaluating potential therapies. Our models closely mimic human disease pathology, offering researchers valuable tools to study Alzheimer’s and develop new treatments.

Aβ-deposition models based on APP/PS1 mutations

The APP gene encodes a transmembrane protein that, when cleaved, forms Aβ peptides—a process regulated by the PSEN1 gene. Manipulating APP and/or PSEN1 in mouse models therefore provides essential insights into AD pathology, allowing researchers to study the mechanisms of amyloid plaque formation and their impact on neurodegeneration.

5xFAD Models?

The 5xFAD models express a total of five AD-linked mutations on the APP and PSEN1 transgenes, leading to the formation of amyloid plaques and very high cerebral Aβ42 levels. These models effectively recapitulate numerous AD-related phenotypes and rapidly develop robust amyloid phenotypes, accompanied by gliosis.

  • B-Tg(5xFAD) mice
  • ROSA26 5xFAD KI mice

APP/PS1 Models

Biocytogen offers a diverse range of additional APP/PS1 models, each carrying one or more AD-associated mutations on the APP and/or PSEN1 genes.

  • B-App NL-F mice
  • B-App NL-G-F mice
  • B-App NL-F mice/Psen1*M146L*E120K mice
  • B-App NL-F mice/Psen1*P117L mice
  • B-App NL-F rats

Tauopathy models and FTD-linked mutation

Tau pathology, characterized by the abnormal aggregation of tau protein that forms neurofibrillary tangles and leads to neuronal dysfunction, is another common feature of AD. Tauopathy models, like those provided by Biocytogen, are valuable tools that offer crucial insights into tau’s role in AD and help identify potential therapeutic targets.


Expression of human TAU protein in homozygous B-hTAU mice.


APOE and TREM2 models

APOE and TREM2 are critical risk genes for Alzheimer’s disease, impacting the buildup and clearance of amyloid plaques. Biocytogen offers humanized mouse models that enable researchers to study these gene’s functions in detail and develop targeted therapies.


Strain specific APOE expression analysis in homozygous B-hAPOE2 (top) and B-hAPOE3 (bottom) mice.


Strain specific TREM2 expression analysis in homozygous B-hTREM2 mice.


Other AD risk gene models

Biocytogen also offers humanized AD models expressing additional risk factors, such as transmembrane glycoproteins, known to impact the function of the blood-brain-barrier in AD.

  • B-hCD98H/hTAU mice
  • B-hTFR1/hTAU mice
  • B-hCD98H/hTAU*P301S mice
  • B-hTFR1/hTAU*P301S mice
  • B-hTREM2/hTFR1 mice

Our humanized mouse models have been instrumental in numerous preclinical studies, accelerating the development of potential Alzheimer’s therapies. Designed to provide reliable data, our models ensure that preclinical findings can be effectively translated into clinical success.

Looking Forward: The Future of Alzheimer’s Treatment

The approval of Kisunla? is a beacon of hope for millions affected by Alzheimer’s disease, signifying progress towards effective treatments and, ultimately, a cure. At Biocytogen, we support this journey by providing researchers with the tools needed to make groundbreaking discoveries.

To learn more about our humanized mouse models and how they can advance your Alzheimer’s research, please request a demo to get in touch with our team.

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