Diagnostic Tool for Progressive Supranuclear Palsy Receives Fast Track Designation from FDA

Aprinoia Therapeutics (Cambridge, MA) announced that the Food and Drug Administration (FDA) has granted Fast Track Designation to APN-1607, a positron emission tomography (PET) imaging tracer, which can be used to detect specific forms of aggregated tau (3R and 4R) in individuals with suspected progressive supranuclear palsy (PSP). PSP is a rare neurodegenerative disorder caused by abnormal accumulation of tau protein in the brain. Currently, there are no FDA-approved diagnostic tests available.

According to Bradford Navia, MD, PhD, Aprinoia’s Chief Medical Officer, "APN1607 is a unique imaging agent as it was designed to detect specific forms of tau implicated in PSP and other related disorders. Sadly, patients with PSP can remain undiagnosed for several years as it is often confused with other Parkinson-like disorders, especially during the early stages." 

Fast Track Designation is intended to expedite development and review of therapies for serious conditions with unmet medical needs. It allows more frequent FDA communication and potential accelerated approval. Aprinoia previously received FDA Orphan Drug Designation for APN-1607 as a PSP diagnostic. In December 2023, Aprinoia received a “Study May Proceed” letter from the FDA to conduct a global phase 3, multicenter, open-label study to evaluate the efficacy and safety of APN-1607 as a diagnostic marker in patients suspected to have PSP.