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 FDA’s Fast Track approval 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).

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international pharmaceutical company committed to the development and delivery of novel, cutting-edge PET radiopharmaceuticals. The company strives to be a leader in the field of molecular imaging. Our mission is to develop innovative PET products that improve the early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and a higher quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key area of ​​modern medicine. LMI is a subsidiary of the Life Healthcare Group – an international, people-focused, diversified healthcare organization with four decades of experience in the South African private healthcare sector. For more information, visit https://life-mi.com.

About Life Healthcare Group
Life Healthcare is a global, people-centric, diversified healthcare company listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years of experience in the South African private healthcare sector and currently operates 64 healthcare facilities in South Africa. Services include acute hospital care, acute physical rehabilitation, acute mental health care, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services including occupational health and wellness services. The group also owns Life Molecular Imaging, a radiopharmaceutical company dedicated to the development and global commercialization of innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/.

For media inquiries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Phone: +1.484.735.2840

Source: Life Molecular Imaging