Fast Track Designation follows announcement in January 2024 that the U.S. Food and Drug Administration (FDA) granted a “Study May Proceed” letter for APRINOIA’s planned Phase 3 study of APN-1607 (florzolotau (18F)) in the U.S., U.K., Europe and Asia
Mediaportalanda, CAMBRIDGE, Mass., May 21, 2024 (GLOBE NEWSWIRE) — APRINOIA Therapeutics Inc. (“APRINOIA” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics and precision diagnostics for the treatment of neurodegenerative diseases, today announced that on May 8, 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to APN-1607 (florzolotau (18F)), a Positron Emission Tomography (PET) tracer for imaging tau protein in patients with suspected progressive supranuclear palsy (PSP).
PSP is a rare neurodegenerative disorder caused primarily by the accumulation of a specific form of tau in subcortical brain regions. There are no FDA-approved diagnostic markers for PSP or any other rare tau-related disorder such as frontotemporal dementia, and until now, diagnosis has primarily relied on clinical assessment. APN-1607 may enable more accurate diagnosis at earlier disease stages, potentially improving patient management and resulting in more efficient clinical trial designs for novel therapies.
“We are very pleased with the FDA’s decision to grant APN-1607 Fast Track Designation as it underscores the significant unmet medical need for a diagnostic marker for the early diagnosis of PSP and potentially other tau-related disorders, including Alzheimer’s disease. APN-1607 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’s like disorders, especially during the early stages. If approved, APN-1607 would provide physicians with an important diagnostic tool that will allow them to diagnose PSP with greater confidence and differentiate it from other disorders, thereby improving the management of these patients,” stated Dr. Brad Navia, Chief Medical Officer of APRINOIA Therapeutics.
“Receiving Fast Track Designation, along with the previously announced “Study May Proceed” letter from the FDA, reinforces the importance of our work related to APN-1607, and specifically, the clinical development plan to advance the asset into the clinic for the early diagnosis of PSP, and potentially other tau-related neurological disorders, including frontotemporal dementia and Alzheimer’s disease. We look forward to our further engagement with the FDA as a part of APN-1607’s Fast Track Designation, as we seek to accelerate the clinical development program for this important diagnostic tracer. We are grateful to our many investigators and partners, including the Alzheimer’s Drug Discovery Foundation and CurePSP for their continued support in our efforts to advance APN-1607 for the diagnosis of PSP and related disorders,” said Dr. Navia.
“Providing patients with neurodegenerative disorders, such as Alzheimer’s, and PSP with an early and accurate diagnosis is critical for determining the best course of treatment as well as accelerating drug development via clinical trials. The Fast-Track Designation for APRINOIA’s PET tracer is a milestone for the field that will serve as the first tau imaging agent for PSP and will add to the arsenal of tau imaging tools for Alzheimer’s. This new generation PET Tracer – in addition to other biomarkers – will move us closer to the day when we can treat the right patients with the right drugs at the right time through a precision medicine approach,” said Dr. Howard Fillit, Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF).
