PR95353

BOSTON, April 11, 2022 /PRNewswire=KYODO JBN/ --

APRINOIA Therapeutics announces today that the U.S. Food and Drug

Administration (FDA) has granted a may proceed authorization for its novel

therapeutic anti-tau monoclonal antibody, APNmAb005, allowing the company to

test and evaluate its safety in healthy subjects in a phase 1 single ascending

dose study.

APNmAb005 is a unique antibody that recognizes a conformation-dependent epitope

present only in pathological forms of tau proteins. It preferentially targets a

population of misfolded tau proteins segregated in specific cellular

compartments, including synapses in brains of patients with Alzheimer's

Disease(AD), as well as primary tauopathies, such as Progressive Supranuclear

Palsy (PSP) and other forms of Frontotemporal Lobar Degeneration (FTLD).

"This is an exciting and important milestone in the history of APRINOIA, which

aims to develop novel therapeutics that target misfolded proteins implicated in

neurodegenerative disorders in addition to developing brain imaging agents that

will enable detection of these proteins. Therapeutic agents targeting tau

proteins have emerged as an important strategy to tackle those diseases. The

pathological tau population identified by APNmAb005 provides new insight into

tau pathology and new possibilities for the discovery of more precise and

targeted treatments", said Dr. Bradford A. Navia, Chief Medical Officer of

APRINOIA.

About APNmAb005

APNmAb005 is a humanized anti-tau antibody specifically targeting human tau

aggregates found in tau-related diseases including Alzheimer's Disease,

Progressive Supranuclear Palsy, Corticobasal Degeneration, and other forms of

Frontotemporal Lobar Degeneration. APNmAb005 preferentially binds tau

aggregates accumulated at the neuronal synapses of AD patients, specialized

sites critical for information transfer and release of transmissible abnormal

tau species between brain cells. Clearance of tau aggregates at neuronal

synapses by APNmAb005 is expected to significantly reduce tau pathology,

synaptic injury, thereby slowing disease progression and restoring brain and

cognitive health.

About APRINOIA Therapeutics

APRINOIA is a late-stage biotechnology company committed to protecting

patients' brain health and changing outcomes of neurodegenerative diseases

through first-in-class and best-in-class diagnostic tools and novel therapies.

The company aims to bring precision medicine to neuroscience by identifying and

targeting the protein aggregates of tau, alpha-synuclein and other proteins

that play a critical role in the pathogenesis of many neurodegenerative

diseases, such as Alzheimer's and Parkinson's Diseases. The company currently

has operations in Hong Kong, Suzhou, Shanghai, Tokyo, and Boston.

SOURCE: APRINOIA Therapeutics