US giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Fast Track designation from the US FDA for its posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) targeting Alzheimer’s disease (AD). This designation is a significant milestone in the development of posdinemab, which is designed to slow down the formation and pathological spread of tau aggregates, thereby delaying cognitive decline in AD patients.
Previous Fast Track Designation
J&J’s JNJ-2056, an anti-tau active immunotherapy being tested for its potential to activate the immune system to help generate antibodies against pathological phosphorylated tau, was granted fast track status by the FDA in July 2024. This immunotherapy is currently being evaluated in the Phase IIb ReTain study.
Current Study and Goals
Posdinemab is currently being investigated in the Phase IIb AuTonomy study in early AD patients. The goal of this study is to evaluate the safety and efficacy of posdinemab in slowing the progression of Alzheimer’s disease, specifically by targeting and reducing the spread of tau aggregates, which are a hallmark of the disease.
Significance of the Fast Track Designation
The Fast Track designation from the FDA is a testament to the potential of posdinemab to address the unmet medical needs of patients with Alzheimer’s disease. This designation will facilitate a more efficient development and review process, potentially accelerating the availability of this innovative therapy to patients in need.-Fineline Info & Tech
