Prothena Corporation plc (NASDAQ:PRTA) noticed a hop in its shares first thing Monday, as the late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PRX012.
This is a potential best-in-class anti-amyloid beta (Aß) antibody in development for the treatment of Alzheimer’s disease (AD). Prothena has initiated the Phase 1 single ascending dose (SAD) study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of PRX012 in both healthy volunteers and patients with AD. Prothena expects to initiate the Phase 1 multiple ascending dose study by year-end 2022.
PRX012 is a next-generation, high binding potency antibody, designed to enable subcutaneous dosing on a patient-friendly, convenient administration schedule, potentially providing greater accessibility for patients and caregivers.
Preclinical data have shown that PRX012 binds to beta amyloid plaques and oligomers with high avidity, enabling effective levels of Aß plaque occupancy at relatively lower dose ranges, which are optimal for subcutaneous delivery.
Additional preclinical data demonstrated clearance of both pyroglutamate modified and unmodified Aß plaque in brain tissue at concentrations of PRX012 estimated to be clinically achievable in the central nervous system with subcutaneous delivery. Compared to first generation anti-Aß antibodies, PRX012 is expected to result in less variance of antibody concentrations in the brain.
PRTA shares gathered 66 cents, or 1.8%, to $37.61.