Biopharmaceutical company Aprionoia Therapeutics announced that it has received an FDA Fast Track Designation for an imaging tracer used to diagnose progressive supranuclear palsy (PSP), an FTD disorder that primarily affects movement.

Aprinoia is evaluating the safety and efficacy of APN-1607, a PET tracer that can visualize two types of tau protein that contribute to the progression of PSP and related tauopathies. The radioactive molecules of the tracer are attached to glucose, which is used in the metabolic functions of the brain; the breakdown of the radioactive molecules is then picked up by a scanner to create a detailed image of an area or to monitor brain activity. Receiving a PSP diagnosis currently relies on clinical assessment once movement-based symptoms begin to show, though misdiagnosis as Parkinson’s or another movement disorder is common.

“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,” said Aprinoia chief medical officer Brad Navia, PhD, MD. “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.”

The FDA’s “Fast Track Designation” is designed to facilitate the development and speed up the regulatory review of drugs or interventions that address an unmet medical need. In addition to increased communication with the FDA, the designation makes APN-1607 eligible for Accelerated Approval and Priority Review.

“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,” Dr. Navia said.

A Phase 3 clinical trial for APN-1607 in China completed enrollment in December 2023. In the same month, Aprinoia received a “study may proceed” letter from the FDA allowing it to conduct a Phase 3 trial in the United States.

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