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Prothena Announces FDA Clearance of IND for PRX012, a Subcutaneous Anti-Amyloid Beta Antibody Under Investigation for the Treatment of Alzheimer’s Disease
Prothena has initiated Phase 1 SAD study of PRX012, under investigation for the treatment of Alzheimer’s disease DUBLIN, Ireland, March 28, 2022 (GLOBE
About this update from Prothena Corporation Plc
[{"type":"text","content":"Prothena has initiated Phase 1 SAD study of PRX012, under investigation for the treatment of Alzheimer’s disease DUBLIN, Ireland, March 28, 2022 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) 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 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 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. Compared to first generation anti-Aβ antibodies, PRX012 is expected to result in less variance of antibody concentrations in the brain. “With Alzheimer’s affecting more than 50 million people worldwide, we are committed to bringing a paradigm-shifting treatment to patients as quickly as possible. Having submitted our IND during this first quarter, we are excited to announce the initiation of this first-in-human study. PRX012’s high binding potency and subcutaneous administration has the potential to serve as a foundational anti-Aβ treatment for Alzheimer’s disease,” said Gene Kinney, Ph. D., President and Chief Executive Officer. “We intend to leverage our multiple decades of experience and expertise in protein dysregulation together with clinical and regulatory l...