Life Molecular Imaging (LMI) has announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to [18F]PI-2620 Injection, an investigational PET imaging agent targeting tau neurofibrillary tangles, for clinical development in neurodegenerative conditions.
The neurodegenerative conditions include in Alzheimer’s disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
The FDA’s Fast Track program is designed to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores the significant potential of [18F]PI-2620 to improve diagnosis of these three devastating neurodegenerative diseases.
[18F]PI-2620 is a next-generation, F18-labeled PET imaging agent currently in Phase 3 clinical development for detecting tau pathology in Alzheimer’s disease.The compound is also being investigated in other neurodegenerative diseases and settings by many academic researchers and in drug development trials. Tau proteins are a hallmark of several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD).
The ability to accurately image tau pathology could significantly enhance disease diagnosis and patient care.
Andrew Stephens, Chief Medical Officer at LMI commented: “Receiving Fast Track Designation from the FDA is a major milestone that highlights the promise of [18F]PI-2620 in addressing the critical need for effective diagnostic tools in Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degeneration.
“This designation not only validates our approach but also facilitates closer collaboration with the FDA to expedite the development of [18F]PI-2620. We are committed to advancing this important imaging agent with the potential to make a meaningful difference for patients who need accurate and accessible Tau PET imaging.”