Initiation of a Phase 2 Multicenter Study of 18F-APN-1607, a Novel Diagnostic PET Imaging Tracer for the Characterization of Tau Burden in Alzheimer's Disease

TAIPEI, Nov. 21, 2019 /PRNewswire/ -- APRINOIA Therapeutics, Inc. announced today that it has initiated a Phase 2 multicenter, multinational study of ¹⁸F-APN-1607 in the US for its lead tau positron emission tomography (PET) tracer in Alzheimer's Disease (AD). The study (NCT number: NCT04141150) will compare tau deposition patterns in patients with mild cognitive impairment due to AD and dementia due to AD with patterns in healthy older adults.

Besides detecting tau aggregates in AD, ¹⁸F-APN-1607 is unique among the tau PET tracers currently in development because it can also visualize 4-repeat tau aggregates characteristic of rare tauopathies, including progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), and the great majority of frontotemporal dementia (FTD) due to tau mutations. Thus, ¹⁸F-APN-1607 may be able to offer broader utilities to detect tau distribution patterns in all tauopathies. This could be valuable for testing tau-focused treatments for AD and other tauopathies and possibly in the future even be clinically useful.

In addition to the Phase 2 study in AD, APRINOIA is establishing a clinical research network with leading imaging centers worldwide to conduct medical research with ¹⁸F-APN-1607. Such research includes clinical/imaging correlation studies, investigation of longitudinal tau pathology progression and spread in individual tauopathies, exploration of potential utilities in differential diagnosis, and studies to develop new AI-based tau PET image analytical tools.

About APRINOIA Therapeutics, Inc.

APRINOIA Therapeutics, headquartered in Taipei, is currently advancing a pipeline featuring three diagnostic and three therapeutic products, collectively targeting brain disorders associated with tau and alpha-synuclein, while pursuing discovery stage research for additional diagnostic and therapeutic agents from its proprietary small molecule and antibody platforms and from external collaborations.

The Company is committed to building a strong pipeline of innovative products, as well as developing valuable collaborations with global and regional pharmaceutical companies to accelerate its product development. The Company currently has operations in Taipei, Shanghai, Suzhou, and Tokyo.

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