---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-013276"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2024-10-15T23:59:59+00:00"
generated_at: "2026-05-30T14:34:13.099090+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.3
calibrated_materiality_score: 0.3
confidence: "high"
source: SEC EDGAR
---

# uniQure doses first patient in Phase I/II trial of AMT-162 gene therapy for SOD1-ALS

## Summary
- First patient dosed in EPISOD1 Phase I/II open-label trial of AMT-162 for SOD1-ALS, a rare inherited progressive motor neuron disease.
- Trial has three dose-escalating cohorts; up to four patients per cohort receiving intrathecal AMT-162 with immunosuppression.
- AMT-162 is an AAVrh10-based gene therapy expressing miRNA to knock down mutated SOD1 protein; granted Orphan Drug and Fast Track FDA designations.
- Four active U.S. sites; plans to activate seven additional sites by Q1 2025.
- Trial will assess safety, tolerability, and exploratory efficacy via neurofilament light chain and SOD1 protein biomarkers.

## SEC filing metadata
- accession: 0001558370-24-013276
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2024-10-15T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.3
- calibrated_materiality_score: 0.3
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000155837024013276/0001558370-24-013276-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000155837024013276/qure-20241015x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-013276
- JSON: https://secwatch.observer/filing/0001558370-24-013276.json
- Plain text: https://secwatch.observer/filing/0001558370-24-013276.txt

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