FDA Grants Fast Track to Life Molecular Imaging's [18F]PI-2620 for Tau PET in Neurodegenerative Diseases

In Boston on August 28, 2024, Life Molecular Imaging (LMI) announced that their investigational PET imaging agent, [18F]PI-2620 Injection, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). This designation is specifically for its clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). The Fast Track program by the FDA aims to speed up the development and review processes for drugs that treat serious conditions and address unmet medical needs. This designation indicates the significant potential of [18F]PI-2620 to enhance the diagnosis of these serious neurodegenerative diseases.

[18F]PI-2620 is a state-of-the-art PET imaging agent labeled with F18, currently in Phase 3 clinical trials for detecting tau pathology in Alzheimer's disease. The compound is also under investigation for other neurodegenerative diseases. Tau proteins, which [18F]PI-2620 targets, are key indicators in several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD). The ability to accurately image tau pathology could greatly improve disease diagnosis and patient care.

Dr. Andrew Stephens, Chief Medical Officer at LMI, emphasized the importance of the Fast Track Designation, stating that it marks a significant milestone in addressing the need for effective diagnostic tools for these diseases. Dr. Stephens highlighted that this designation not only validates the approach LMI is taking but also enables closer collaboration with the FDA, thereby expediting the development of [18F]PI-2620. He underscored the commitment of LMI to advance this imaging agent, which has the potential to significantly benefit patients requiring accurate and accessible Tau PET imaging.

[18F]PI-2620 was discovered and developed through a research collaboration between AC Immune and LMI. LMI holds the exclusive global license for the research, development, and commercialization of Tau PET tracers produced within this discovery program. The agent has shown strong brain uptake, rapid clearance from non-target regions, and excellent reproducibility between test and retest scans. The lack of significant off-target binding allows [18F]PI-2620 to detect and quantify early tau deposition in the brain. The agent is currently being investigated in several clinical studies, including a Phase 3 image-to-autopsy study, for its ability to detect tau deposits in the human brain. It also shows promise for detecting tau in non-AD tauopathies like PSP and CBD.

Life Molecular Imaging (LMI) is an international pharmaceutical company focused on developing and offering advanced PET radiopharmaceuticals. Their mission is to lead in the molecular imaging field by pioneering innovative PET products that enhance the early detection and characterization of chronic and life-threatening diseases, ultimately leading to better therapeutic outcomes and improved quality of life. LMI is an affiliate of the Life Healthcare Group, a global, diversified healthcare organization with four decades of experience in the South African private healthcare sector.

Life Healthcare is listed on the Johannesburg Stock Exchange and operates 64 healthcare facilities in southern Africa. Their services encompass acute hospital care, rehabilitation, mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging, and health risk management, including occupational health and wellness services. The Group also owns LMI, which is dedicated to developing and globally commercializing innovative molecular imaging agents for PET-CT diagnostics to detect specific diseases.