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A Phase 1/2, Multicenter, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Intrathecally Administered Gene Therapy AMT-162 in Adult Participants with SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS).

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Trial Profile

A Phase 1/2, Multicenter, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Intrathecally Administered Gene Therapy AMT-162 in Adult Participants with SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS).

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs AMT 162 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions
  • Acronyms EPISOD1
  • Sponsors Apic Bio; uniQure

    • Most Recent Events

    • 27 Feb 2025 According to an uniQure media release,the company expects to present initial data from this study in the first half of 2026.
    • 30 Jan 2025 According to an uniQure media release, company expects to initiate enrollment of second dose cohort in the first quarter of 2025
    • 30 Jan 2025 According to an uniQure media release, company announced that the Independent Data Monitoring Committee (IDMC) for EPISOD1, uniQure's Phase I/II clinical trial of AMT-162, an investigational gene therapy for amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene, has met and reviewed 28-day safety data from the first study cohort.The IDMC's review identified no significant safety concerns and recommended proceeding with enrollment in the second cohort.

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