JnJ Posdinemab gets USFDA Fast Track Designation for treatment of Alzheimer's disease
Posdinemab is an investigational monoclonal antibody that targets the mid-domain of Alzheimer's disease-specific phosphorylated tau.
Titusville: Johnson & Johnson has announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being investigated to treat patients with early Alzheimer’s disease (AD) in the Phase 2b “AuTonomy” study.
The internally discovered mAb has shown the potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid (CSF) from treated AD patients, and in blocking the development and spread of tau aggregates in non-clinical models of disease.
“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. At J&J, we envision a future where we can help stop the progression of AD the moment it’s detected,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “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.”
Posdinemab is the second Fast Track designation granted in 2024 for the Company’s AD portfolio. J&J’s anti-tau active immunotherapy, JNJ-2056, the first active immunotherapy targeting tau in a preclinical AD population, was also granted Fast Track designation in July 2024. The Phase 2b “ReTain” trial, which is actively enrolling, will evaluate the potential of JNJ-2056 to activate the immune system to help generate antibodies against pathological phosphorylated tau, with the goal of delaying or preventing onset of symptoms, and ultimately disease progression.
Fast Track is a process designed by the FDA to expedite the review of therapies that treat serious conditions with a high unmet need, with the aim of getting therapies to patients earlier.
Globally, 55 million people live with dementia, with AD accounting for 60–80 percent of cases. AD is a neurodegenerative disorder marked by progressive memory loss and other cognitive decline that disrupts daily life, leaving patients requiring around-the-clock care and ultimately, leading to death.
Alzheimer’s disease (AD), the most common form of dementia worldwide, is a fatal neurodegenerative disorder characterized by progressive memory loss and a decline in other cognitive abilities severe enough to significantly interfere with daily life. Diagnostic criteria for AD are based on established classifications but continue to evolve as research advances. Preclinical AD refers to individuals with detectable Alzheimer’s disease pathology (amyloid and tau) who are cognitively unimpaired. Early Alzheimer’s disease includes individuals with mild cognitive impairment due to Alzheimer’s disease (also known as prodromal AD) and mild Alzheimer’s dementia.
The Phase 2b “AuTonomy” study investigating posdinemab in participants with early Alzheimer’s disease is fully enrolled and ongoing (NCT04619420).
