The FDA has granted Life Molecular Imaging (LMI) fast-track designation for its investigational F18-labeled PET imaging agent, allowing for its clinical development in Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degeneration.

[18F]PI-2620 was developed as part of a research collaboration between LMI and biopharmaceutical company, AC Immune. It’s currently in Phase 3 clinical development for detecting tau pathology in Alzheimer’s patients and is also being investigated by academic researchers and in drug development trials for other neurodegenerative diseases.

The FDA grants fast track designation to a new drug if it will have an impact on patient survival, day-to-day functioning or the likelihood that a condition will progress from less severe to more serious if it’s not treated.

"This designation not only validates our approach but also facilitates closer collaboration with the FDA to expedite the development of [18F]PI-2620,” Andrew Stephens, chief medical officer at LMI, said in a statement. “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."

[18F]PI-2620 has already demonstrated strong brain uptake and that it can quickly clear from non-target regions and provide consistent results across multiple scans. Since it doesn’t bind much to non-target regions, it’s able to accurately detect and quantify early tau build-up in the brain.

A study published in the Journal of Nuclear Medicine in 2020 investigated the use of [18F]PI-2620 on 12 subjects with probable Alzheimer's disease and 10 healthy controls. The researchers found that there was an increase in uptake of [18F]PI-2620 among the Alzheimer's subjects compared to the controls.

The study also found that since [18F]PI-2620 exhibits very fast brain uptake and clearance from non-target regions, a PET exam with this imaging agent takes only about one hour.

It’s also showing promise in detecting tau in non-AD tauopathies like progressive supranuclear palsy, and corticobasal degeneration. Those diseases involve some of the same symptoms as Parkinson’s Disease and may also affect memory and thinking.

Currently, the agent is under investigation in several clinical studies as a targeted radiopharmaceutical for detecting tau deposits in the human brain. One of those is a Phase 3 image-to-autopsy study.

Molecular Imaging Homepage