Posdinemab Becomes J&J’s Second FDA Fast Track Designation Targeting Phosphorylated Tau in Alzheimer’s Disease

Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to posdinemab, a monoclonal antibody (mAb) designed to target phosphorylated tau, for the treatment of early Alzheimer’s Disease (AD). Posdinemab is currently under evaluation in the Phase 2b “AuTonomy” clinical trial. Discovered in-house, the antibody has demonstrated the ability to target disease-associated phosphorylated tau in cerebrospinal fluid from patients receiving treatment and to inhibit the formation and spread of tau aggregates in preclinical disease models.

Phase 2b “ReTain” Trial Investigates JNJ-2056’s Potential to Delay Cognitive Decline in Alzheimer’s Disease

The FDA designed the Fast Track process to speed up the review of therapies that address serious conditions with high unmet needs, allowing patients to access treatments sooner. Posdinemab marks the second Fast Track designation Johnson & Johnson has received in 2024 for its Alzheimer’s disease portfolio. Similarly, in July 2024, the FDA also granted Fast Track designation to JNJ-2056, the company’s anti-tau active immunotherapy and the first active immunotherapy targeting tau in a preclinical Alzheimer’s disease population. 

The Phase 2b “ReTain” trial, currently enrolling participants, aims to assess JNJ-2056’s ability to stimulate the immune system to produce antibodies against pathological phosphorylated tau, with the objectives of delaying or preventing symptom onset and slowing disease progression.

“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,” stated Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine.

55 Million People Affected by Dementia and Evolving Diagnostic Criteria Including Cognitive Impairment

Approximately 55 million people worldwide are affected by dementia, with Alzheimer’s disease representing 60–80 percent of these cases. AD is a neurodegenerative condition that gradually causes memory loss and other cognitive impairments, progressively interfering with daily activities. As the disease advances, patients often require continuous care, and it ultimately leads to death.

Researchers ground the diagnostic criteria for AD in established classifications; however’ they continue to evolve with ongoing studies. In particular, preclinical AD refers to individuals who show detectable Alzheimer’s pathology, including amyloid and tau, yet remain cognitively unimpaired. Moreover, early Alzheimer’s disease encompasses those with mild cognitive impairment due to Alzheimer’s disease (prodromal AD) as well as individuals with mild Alzheimer’s dementia.

In line with this vision, Johnson & Johnson is developing posdinemab. This investigational monoclonal antibody binds to pathological phosphorylated tau when released from neurons and neutralizes it before it can spread to other neurons. Furthermore, the compound has shown potential in reducing tau seeding in both in vitro and in vivo preclinical studies. The Phase 2b “AuTonomy” study, investigating the use of posdinemab in participants with early Alzheimer’s disease, has completed enrollment and is currently ongoing.

“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,” reemphasized Bill Martin.

Author

Denisse Sandoval