Life Molecular Imaging (LMI) has received Fast Track Designation from the US Food and Drug Administration (FDA) for [18F]PI-2620 Injection in tau PET imaging across three neurodegenerative conditions.
The [18F]PI-2620 is an investigational, advanced F18-labeled PET imaging agent that targets tau neurofibrillary tangles. It is currently in Phase 3 clinical development for detecting tau pathology in Alzheimer’s Disease (AD).
It has received fast track status for clinical development in AD, progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
The fast track programme is intended to expedite the development and review of drugs for serious conditions that meet unmet medical needs.
According to Life Molecular Imaging, this designation highlights the potential of this imaging agent to enhance the diagnosis of these neurodegenerative diseases.
Life Molecular Imaging chief medical officer Andrew Stephens said: “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.”
Academic researchers are also exploring the advanced compound in drug development trials and in various neurodegenerative conditions and research settings.
The capability to precisely image tau pathology can support improving disease diagnosis and patient management, LMI said.
The [18F]PI-2620 was developed through a research collaboration between AC Immune and Life Molecular Imaging (LMI).
LMI, an affiliate of Life Healthcare Group, holds the exclusive worldwide licence for the research, development, and commercialisation of Tau PET tracers created within this discovery programme.
It has shown strong brain uptake, rapid wash-out in non-target areas, and reproducibility between test and retest scans.
In addition, its minimal off-target binding allows for precise detection and quantification of early tau deposition in the brain, LMI said.
Currently, [18F]PI-2620 is being evaluated in several clinical studies, including a Phase 3 image-to-autopsy study, to assess its effectiveness in detecting tau deposits.
Recently, LMI and PharmaLogic partnered to distribute FDA-cleared Neuraceq imaging agents in Denver, US.
