SUZHOU, China, Oct. 28, 2020 /PRNewswire/ -- 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.