Neuroscience biopharmaceutical company Aprinoia Therapeutics has announced that the China National Medical Products Administration has approved the company's phase III clinical trial of its PET imaging tracer.
The tracer, F-18 APN-1607, can recognize tau proteins in pathological aggregated states but not normal physiological ones. It is part of a new generation of tau radiotracers that have better selectivity and off-target binding profiles, the company noted.
The phase III trial is the next step toward commercialization of the radiotracer. It will evaluate the safety and efficacy of F-18 APN-1607 to differentiate patients with cognitive impairment from healthy subjects. The trial intends to enroll about 230 subjects, including patients with mild cognitive impairment and various stages of Alzheimer's disease.
