Posdinemab Granted Fast Track Designation by the FDA for Early Alzheimer Disease
Posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being studied for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the US Food and Drug Administration (FDA) on Wednesday, January 8, 2025, drug manufacturer Johnson & Johnson announced via news release.
The investigational therapy has shown potential in targeting phosphorylated tau in the cerebrospinal fluid of AD patients, blocking the development and spread of “tau aggregates.” The phase 2B “AuTonomy” study of posdinemab is fully enrolled and ongoing (NCT04619420).
“At [Johnson & Johnson], we envision a future where we can help stop the progression of AD the moment it's detected," said Bill Martin, PhD, 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.”
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The designation for posdinemab is based on phase 1 studies published in The Journal of Prevention of Alzheimer’s Disease, which reported observation of “dose-dependent reductions in free and total p217+tau” alongside general safety and tolerability of the agent in healthy participants with AD.
“The safety and biomarker profiles support the continued investigation of this compound for the slowing of disease progression in Alzheimer disease,” said Wendy Galpern, MD, PhD, medical director, Neuroscience Clinical Development Group, Janssen Research and Development, and coauthors.
The FDA’s Fast Track process is designed to expedite the review of therapies that address serious conditions that lack treatment options, with the ultimate goal of connecting patients to needed therapies more quickly.
Another Johnson & Johnson investigational agent, JNJ-2056, received Fast Track designation in 2024. The anti-tau active immunotherapy targets the c-terminal region of pathological phosphorylated tau and is designed to “inhibit the seeding and spreading of pathological tau” to delay the onset of symptoms in preclinical AD. The phase 2b “ReTrain” trial is actively enrolling participants (NCT06544616).
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