APRINOIA Announces Approval from NMPA to Initiate Phase 3 Clinical Trial in China for [18F]-APN-1607 Tau PET Imaging Tracer for Dementia

APRINOIA Therapeutics announced that China National Medical Products Administration (NMPA) had approved to initiate Phase 3 clinical trial to evaluate APRINOIA's positron emission tomography (PET) imaging tracer, [18F]-APN-1607, targeting abnormal tau protein aggregates in brains of patients of cognitive impairment.

[18F]-APN-1607 is a new generation tau PET imaging tracer with improved selectivity and off-target binding profiles. It is designed to specifically recognize tau proteins in their pathological aggregated states, but not normal physiological ones. The objective of the Phase 3 clinical trial is to evaluate safety and effectiveness of [18F]-APN-1607 to differentiate patients with Mild Cognitive Impairment (MCI) and different stages of Alzheimer's disease (AD) from healthy subjects. The proposed trial will enroll approximately 230 subjects with all receiving [18F]-APN-1607.

"We are excited that [18F]-APN-1607 is now one step forward towards commercialization" said Dr. Tzu-Chen Yen, head of APRINOIA's China subsidiary. "Precise diagnosis is the foundation to formulate effective treatment plans for patients of neurodegenerative diseases. Our goal is to provide country-wide access to [18F]-APN-1607 across China in the future, to enable precise diagnosis, accurate monitoring of disease progression and regression, and early detection and treatment."

Pathological tau proteins are associated with neurodegeneration in AD, as well as in other tau-related brain disorders, a.k.a. tauopathies, including progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). Tau abnormality has been recognized as a key biomarker to characterize those tauopathies. [18F]-APN-1607 could quantify and visualize tau burden and distribution in all those tauopathies, offering broader clinical utilities.

About APRINOIA Therapeutics

APRINOIA Therapeutics is currently advancing a pipeline featuring diagnostic and therapeutic programs, collectively targeting brain disorders associated with abnormal accumulation of pathological proteins, including tau and alpha-synuclein, from its proprietary small molecule and antibody discovery platforms. APRINOIA is committed to building a pipeline of innovative products, as well as developing partnership with global and regional pharmaceutical companies to accelerate its programs. The company currently has operations in Taipei, Suzhou, Shanghai, Tokyo, and Boston.