---
schema_version: "secwatch.filing_event.v1"
accession: "0001559053-22-000014"
form_type: "8-K"
ticker: "PRTA"
cik: "0001559053"
company_name: "PROTHENA CORP PUBLIC LTD CO"
filed_at: "2022-03-28T23:59:59+00:00"
generated_at: "2026-06-26T16:03:59.639574+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for Prothena's PRX012 subcutaneous anti-Aβ antibody; Phase 1 SAD study initiated

## Summary
- 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.

## SEC filing metadata
- accession: 0001559053-22-000014
- form_type: 8-K
- ticker: PRTA
- cik: 0001559053
- company_name: PROTHENA CORP PUBLIC LTD CO
- filed_at: 2022-03-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1559053/000155905322000014/0001559053-22-000014-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1559053/000155905322000014/prta-20220328.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001559053-22-000014
- JSON: https://secwatch.observer/filing/0001559053-22-000014.json
- Plain text: https://secwatch.observer/filing/0001559053-22-000014.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.