Pipeline
PreDX and Alzheimer´s disease
Alzheimer’s disease (AD) is a complex neurodegenerative disorder primarily characterized by progressive memory loss and cognitive decline. In recent years, the treatment landscape has undergone a historic shift with the introduction of novel antibody-based drugs. Unlike earlier therapies that only managed symptoms, these new treatments have been shown to slow disease progression—a major milestone in the field.
However, these breakthrough therapies come with significant challenges. For example, recently FDA approved drugs of this kind — such as Donanemab (Lilly), Lecanemab (Eisai/Biogen/BioArctic) — have shown promising results in reducing Aβ deposits and improving cognitive function; however up to 30% of AD patients taking immunotherapy were hit with a side effect called Amyloid-Related Imaging Abnormalities (ARIA) a serious swelling of the brain, in worst cases leading to bleeding, lasting brain damage, and death.
Pre Diagnostics is addressing this need
Our proprietary technology has the potential to provide clinicians with a powerful tool during antibody-based immunotherapy, helping to tailor treatment to each patient’s risk profile. We are currently developing two complementary blood-based diagnostic solutions:
1
BloodCellDx-AD – to predict the risk of ARIA before initiating immunotherapy.
2
Plasma Aβx-34 CE-Marked Biomarker – to monitor ARIA during the course of treatment.
Together, these tools aim to optimize patient selection, reduce adverse effects, and increase the number of patients who can safely benefit from breakthrough Alzheimer’s treatments.
By enabling predictive ARIA risk assessment and ongoing monitoring, Pre Diagnostics is positioned to play a vital role in the next generation of precision medicine for AD.
Science behind:
(1) Xavier Taylor et al. Amyloid-β (Aβ) immunotherapy induced microhemorrhages are associated with activated perivascular macrophages and peripheral monocyte recruitment in Alzheimer’s disease mice, Mol. Neurodegener. 10.1186/s13024-023-00649-w (2023).
(2) Lapenna, A., De Palma, M. & Lewis, C.E. Perivascular macrophages in health and disease. Nature reviews immunology doi: 10.1038/s41577-018-0056-9 (2018).
(3) Xavier Taylor et al. Aβ immunotherapy drives immune activation and cerebrovascular damage in a mouse model of Alzheimer’s Disease, Alzheimer´s & Dementia doi: 10.1002/alz.085423 (2024).
