Fast-track status granted for use in patients being evaluated for Alzheimer’s disease, progressive supranuclear palsy or corticobasal degeneration

BOSTON, 28 August 2024 /PRNewswire/ — Life Molecular Imaging (LMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to (18F)PI-2620 Injection, an investigational PET imaging agent targeting tau neurofibrillary tangles. Fast Track Designation was granted for clinical development 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 diseases and unmet medical needs. This designation underscores the significant potential of (18F)PI-2620 to improve the 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 the detection of tau pathologies in Alzheimer’s disease. The compound is also being studied by many academic researchers and in drug development trials in other neurodegenerative diseases and other settings. Tau proteins are a hallmark of several neurodegenerative diseases, including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD). The ability to precisely image tau pathologies could significantly improve disease diagnosis and patient care.

“The granting of Fast Track designation by the FDA is an important milestone that underscores the potential of (18F)PI-2620 to address the urgent need for effective diagnostic tools for Alzheimer’s disease, progressive supranuclear palsy and corticobasal degeneration,” said Andrew StephensChief Medical Officer at LMI. “This award not only validates our approach, but also facilitates closer collaboration with the FDA to advance the development of (18F)PI-2620. We are committed to continuing to advance this important imaging agent that has the potential to make a meaningful difference for patients who require accurate and accessible tau PET imaging.”

About (18F)PI-2620

(18F)PI-2620 is an experimental PET imaging agent discovered and developed through a research collaboration between AC Immune and LMI. LMI holds the exclusive worldwide license to research, develop and commercialize tau PET tracers generated through the discovery program. (18F)PI-2620 has demonstrated robust uptake in the brain and rapid washout in non-target regions, as well as excellent reproducibility between test and repeat scans. The lack of significant off-target binding enables (18F)PI-2620 to detect and quantify early tau deposits in the brain. (18F)PI-2620 is currently being evaluated in several clinical trials as a targeted radiopharmaceutical to detect tau deposits in the human brain, including a Phase 3 image-to-autopsy study. (18F)PI-2620 also shows promise for the detection of tau in non-AD tauopathies such as progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD).