APRINOIA Therapeutics is a clinical-stage biotechnology company committed to protecting patients’ brain health and changing clinical outcomes through best-in-class diagnostic tools and novel therapeutics.

Early diagnosis is difficult for many neurodegenerative disorders. To address this significant unmet need, Aprinoia is developing ¹⁸F-APN-1607 (APN-1607), a new generation PET tracer, that will enable clinicians to visualize tau, an important protein that accumulates in brains of patients with common and rare neurodegenerative disorders, such as Alzheimer’s Disease (AD) and Progressive Supranuclear Palsy (PSP). Compared to other PET tracers, APN-1607 shows higher specific binding to tau aggregates in across different tau- related brain disorders, including AD, PSP, corticobasal syndrome (CBS), and frontotemporal dementia (FTD).

Based on a large body of nonclinical and clinical studies, including patients with PSP, APRINOIA plans to initiate a single, pivotal, Phase 3 study for the regulatory approval of APN-1607 as a diagnostic agent for PSP and other tau-related disorders. This study will enroll approximately 140 subjects including 100 patients with PSP, CBS and FTD and 40 age-matched controls. Subjects will undergo PET APN-1607 imagng, MRI and clinical assessments. PET images will be analyzed using qualitative and quantitative methods, including a novel visual read method in development and machine learning approaches. Brain sections from patients with these disorders will be examined with APN 1607 and markers for tau protein to establish the link between APN-1607 and its binding to tau deposits. The PET imagng results will be compared across disorders, their variants and at different disease stages.

APN-1607, once approved, will provide clinicians with a powerful tool to make more accurate diagnosis and to differentiate among different tau-related brain diseases. Importantly, APN-1607 will enable clinicians to identify patients for treatment with novel or experimental therapies that are more likely to be effective at earlier stages.