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Posdinemab Receives FDA Fast Track Designation for Treatment of Alzheimer Disease
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Key Takeaways
- Posdinemab, a monoclonal antibody, targets phosphorylated tau to potentially slow cognitive decline in early Alzheimer's disease.
- Alzheimer's disease is the most common form of dementia, affecting 55 million people globally, with no current cure.
As an investigational monoclonal antibody, posdinemab targets the mid-domain of AD-specific phosphorylated tau.
The FDA has granted fast track designation to posdinemab (JNJ-63733657; Johnson & Johnson), a phosphorylated tau-directed monoclonal antibody (mAb) intended to treat individuals with early Alzheimer disease (AD). The designation was granted based on the ongoing phase 2b AuTonomy trial (NCT04619420) that is investigating treatment with posdinemab among individuals with early AD.1
AD is a neurodegenerative disorder that destroys memory and thinking skills over time and eventually disrupts daily life, causing the individual to lose ability to perform basic tasks.1,2 According to the Alzheimer’s Association, the disease is the most common form of dementia and can range in severity based on the types of brain changes taking place.2,3 The study authors noted that 55 million individuals live with dementia globally, with AD accounting for 60% to 80% of cases.1
Preclinical AD signifies individuals with detectable AD pathology, including amyloid and tau, who are cognitively unimpaired. Additionally, early AD refers to individuals with mild cognitive impairment that is caused by prodromal AD and mild AD dementia. Despite advancements in AD treatment, there is still no cure for the disease, emphasizing the need for further options.1
"As the average age of the global population increases, the number of people impacted by this debilitating progressive disease continues to rise. Alzheimer's disease places a substantial emotional and financial burden on patients and their loved ones and has a significant economic and societal impact," said Bill Martin, PhD, global therapeutic area head of Neuroscience at Johnson & Johnson Innovative Medicine, in a news release.1
As an investigational monoclonal antibody, posdinemab targets the mid-domain of AD-specific phosphorylated tau. The drug was created to bind to pathological phosphorylated tau when it is released from neurons, aiming to neutralize it before it can spread to another neuron, according to study authors.1
"Posdinemab has the potential to slow the spread of tau pathology in the brain - which may slow cognitive decline. The FDA's fast track designation reflects the urgent unmet need for new treatment options for the millions living with AD,” said Martin, in a news release.1
Posdinemab is the second recent fast track designation for Johnson & Johnson, as JNJ-2056 (ACI-35.030; Johnson & Johnson) was granted a designation as the first active immunotherapy targeting tau in a preclinical AD population. The investigational anti-tau active immunotherapy targeting the c-terminal region of pathological phosphorylated tau is designed to inhibit the spread of pathological tau. A phase 2b ReTain trial (NCT06544616) is currently enrolling patients with preclinical AD who have tau present in their brains but have not developed cognitive impairment.1
