Suzhou, China- October 28, 2020- 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.
关于新旭生技
新旭生技股份有限公司成立于2015年，专注于神经退化性疾病领域，具备领先药物筛选平台与技术，针对脑部变异的tau 及alpha-synuclein蛋白，开发大分子与小分子治疗药物及相关的影像诊断示踪剂。新旭生技汇聚全球医疗科研人才，在台北、苏州、上海、东京，以及波士顿设立运营子公司与据点，共同为实现脑部精准诊断和治疗而努力。
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