2022-04-11

APRINOIA Therapeutics received FDA clearance to initiate APNmAb005 Phase 1 clinical trial

BOSTON, April 11, 2022 -- 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.