regulatory
confidence high
sentiment positive
materiality 0.80
FDA clears IND for Prothena's PRX012 subcutaneous anti-Aβ antibody; Phase 1 SAD study initiated
PROTHENA CORP PUBLIC LTD CO
- FDA cleared IND for PRX012, a potential best-in-class anti-amyloid beta antibody for Alzheimer's disease.
- Phase 1 single ascending dose study in healthy volunteers and AD patients has started; MAD study expected by year-end 2022.
- PRX012 designed for subcutaneous dosing with high binding potency; preclinical data show plaque occupancy at low doses.
- Prothena expects PRX012 to serve as a foundational anti-Aβ treatment with convenient administration.