Johnson & Johnson (J&J) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to two of its investigational Alzheimer's disease therapies: posdinemab and JNJ-2056. This designation underscores the company's commitment to addressing the significant unmet medical needs in Alzheimer's disease treatment. Fast Track status is intended to facilitate the development and expedite the review of drugs targeting serious conditions and filling unmet medical needs, potentially leading to earlier patient access.
Targeting Tau Pathology in Alzheimer's
Posdinemab, a monoclonal antibody (mAb) targeting phosphorylated tau, is currently in a Phase 2b trial named "AuTonomy" (NCT04619420) for patients with early Alzheimer's disease. The treatment aims to slow the spread of tau pathology, which is associated with cognitive decline. According to 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."
JNJ-2056, an anti-tau active immunotherapy, received Fast Track designation in July 2024. The "ReTain" trial (NCT06544616) is assessing JNJ-2056's ability to activate the immune system against pathological phosphorylated tau in individuals with preclinical Alzheimer's disease, with the goal of delaying or preventing disease progression. The Phase 2b "ReTain" trial is actively enrolling participants.
The Urgent Need for New Treatments
Alzheimer's disease is a progressive neurodegenerative disorder that accounts for 60-80 percent of dementia cases worldwide. Globally, 55 million people live with dementia. There is currently no cure for Alzheimer's disease, which eventually leads to death after a long period of cognitive decline and loss of the ability to perform daily tasks. With the global population aging, the number of individuals affected by Alzheimer's disease is expected to rise, emphasizing the need for new treatment options.
J&J's Broader Efforts
Both posdinemab and JNJ-2056 are part of Johnson & Johnson's broader efforts to develop treatments that could potentially prevent, treat, and cure complex diseases like Alzheimer's. The company's vision includes creating solutions that are smarter and less invasive, tailored to individual needs.
About the Investigational Therapies
Posdinemab is designed to bind to pathological phosphorylated tau when it is released from neurons and neutralize it before it can seed/spread to another neuron. The internally-discovered compound has shown promise in reducing tau seeding in both in vitro and in vivo non-clinical studies.
JNJ-2056 is designed to inhibit the seeding and spreading of pathological tau, with the goal of delaying or preventing the onset of clinical symptoms in preclinical Alzheimer's disease (AD).
Study Details
The Phase 2b "AuTonomy" study is a double-blind, placebo-controlled, randomized, parallel-group study assessing the effect of two doses of posdinemab (low or high dose) or placebo every 4 weeks over a 104-week treatment period. It includes patients with symptomatic AD who meet clinical and plasma phosphorylated (p-tau)217 criteria followed by intermediate levels of tau burden on tau PET.
The Phase 2b "ReTain" study is evaluating JNJ-2056 in participants with preclinical AD who have tau pathology in their brains but have not yet developed cognitive impairment.
