PR86274

SUZHOU, China, Oct. 28, 2020 /PRNewswire=KYODO JBN/ --

APRINOIA Therapeutics announced today 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.

Source: APRINOIA Therapeutics