Life Molecular Imaging announced it has commenced a Phase III clinical trial of PI-2620, a tau PET (positron emission tomography) imaging agent as a diagnostics for Alzheimer’s disease (AD). The open-label, multi-center, non-randomized trial, called ADvance, will assess the safety and efficacy of PI-2620 for the detection of tau deposition in patients with AD. The trial will enroll roughly 200 end-of-life patients and is being conducted exclusively in the U.S. The primary objective is to determine the sensitivity and specificity of the visual assessment of PI-2620 PET imaging compared with postmortem histopathological verification of the tau neurofibrillary pathology associated to AD.
PI-2620, discovered as part of a collaboration between Life Molecular and neurodegenerative disease biopharma company AC Immune, is dubbed a potentially best-in-class PET tracer that has exhibited a high binding affinity and selectivity for aggregated tau, an important indicator of neuronal death that has shown a strong correlation to cognitive decline in AD. Improving imaging agents for earlier and more accurate detection of tau aggregation has the potential to improve the diagnosis and related cognitive performance of patients with AD and other tauopathies.
“A validated tau PET tracer will lead to an improved understanding of the pathophysiology of tauopathies and may aid in establishing an earlier and more accurate clinical diagnosis of neurodegenerative diseases,” said Ludger Dinkelborg, CEO of Life Molecular Imaging. “…the start of this Phase III study marks another milestone on our vision to reduce the burden of disease by improving early diagnosis and characterization of chronic and life-threatening diseases. This unique tau imaging biomarker is an important addition to Neuraceq, our approved and globally available beta-amyloid targeting product, thereby complementing our neurodegeneration portfolio.”
While earlier diagnosis of AD is vital to improving care for patients suffering from the disease, it also provides a window to visualize how AD develops which is vital to the discovery and development of new and more effective therapies. PI-2620’s properties that make it a promising imaging agent for earlier diagnosis include robust brain uptake and fast wash-out in non-target regions, an imaging window between 30- and 90-minutes post-injection for AD, and excellent reproducibility between test and retest scans. Due to the absence of off-target binding, the agent can detect and quantify early tau deposits in the brain.
“The ability to detect and quantify aggregated Tau with enhanced sensitivity and specificity, will improve our diagnostic confidence and accelerate clinical development of therapeutic interventions, said Andrea Pfeifer, CEO of AC Immune. “This development underscores the strength of our Morphomer platform which continues to generate excellent candidates against multiple pathological proteins involved in neurodegenerative diseases.”