Alzheimer's disease (AD)
Cellular accumulation of aggregated forms of the protein tau is a defining feature of tauopathies such as Alzheimer’s disease, progressive supranuclear palsy, and chronic traumatic encephalopathy.
Unmet medical needs
Alzheimer's disease (AD) is a chronic neurodegenerative disease that usually starts slowly and gradually worsens over time, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Although there is medication available that can temporarily reduce the symptoms, there's currently no cure for AD.
Target patient
The dementia patients in Korea is expected to exceed 1 million in 2024 and AD is the cause of 60-70% of cases of dementia. AD is the sixth-leading cause of death in the United States and an estimated 5.8 million Americans age 65 and older are living with AD in 2020.
Development stage
Preclinical phase - Aim to file a new drug (IND) application in 2Q23 to start clinical trials in 4Q23.
Competitive drug
Despite the enormous amount of investment in the past decades, therapies that targeted to lower the burden of amyloid beta, another hallmark of AD dementia, have all but failed. The first amyloid beta-directed antibody was approved in 2021. However, tau proteins are more closely related to the progress of Alzheimer’s disease than amyloid beta, and tau proteins are drawing attention as a therapeutic target recently. Globally there are only a few competitors under development.
Competitive advantages
Tau is a large protein with 441 amino acids and various, extensive post-translational modifications, which makes it hard to choose the right epitope in tau proteins for therapeutic effects. Adel-Y01 targets a unique, disease-specific epitope different to that of competitors. It has shown superior activities in inhibiting propagation and aggregation of Tau protein in the preclinical studies. It is anticipated that ADEL-Y01 will help stop or slow the progression of AD dementia by inhibiting tau spreading and facilitating its clearance by microglia.