APRINOIA THERAPEUTICS' DIAGNOSTIC TOOL RECEIVES FAST TRACK DESIGNATION FROM FDA

KUALA LUMPUR, May 23 (Bernama) -- APRINOIA Therapeutics Inc (APRINOIA) announced the United States (US) Food and Drug Administration (FDA) recently granted Fast Track Designation (FTD) to APN-1607, 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, and 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.

According to APRINOIA in a statement, 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.

APRINOIA Chief Medical Officer, Dr Brad Navia said FDA’s decision to grant APN-1607 FTD 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.

“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,” he said.

FTD is designed to facilitate the development and expedite the review of product candidates that demonstrate the potential to address an unmet medical need, with the goal of advancing important new diagnostic and treatment options to patients more quickly than traditional regulatory routes.

Once a drug candidate receives FTD, early and frequent communication with the FDA, including discussions around the product candidate’s development plan and regulatory review process are ensured. If the relevant criteria are met, the product candidate may be eligible for Accelerated Approval and Priority Review by the FDA.

Headquartered in Cambridge, Massachusetts, APRINOIA is a clinical-stage biotechnology company committed to developing highly sensitive as well as selective diagnostic and therapeutic agents for a broad range of neurodegenerative diseases.

-- BERNAMA