On 28 March, Prothena Corporation, a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, announced that the US Food and Drug Administration (FDA) has cleared the investigational new drug application for PRX012, a potential best-in-class anti-amyloid beta (Aβ) antibody in development for the treatment of Alzheimer’s disease (AD). Prothena has initiated the Phase I single ascending dose study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of PRX012 in both healthy volunteers and people with AD. In this Phase I single ascending dose study, participants will be randomised to receive a single subcutaneous injection of either PRX012 or placebo.
The company expects to initiate the Phase I multiple ascending dose study by end 2022. In preclinical studies, data have shown that PRX012 binds to beta amyloid plaques and oligomers with high avidity, enabling effective levels of Aβ plaque occupancy at relatively lower dose ranges, which are optimal for subcutaneous delivery. Additional preclinical data demonstrated clearance of both pyroglutamate modified and unmodified Aβ plaque in brain tissue at concentrations of PRX012 estimated to be clinically achievable in the central nervous system with subcutaneous delivery.
