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A Phase 1/2 Intracerebroventricular and Intravitreal Administration of NGN-101 for Treatment of Neuronal Ceroid Lipofuscinosis (NCL) Subtype 5 (CLN5) Disease

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Trial Profile

A Phase 1/2 Intracerebroventricular and Intravitreal Administration of NGN-101 for Treatment of Neuronal Ceroid Lipofuscinosis (NCL) Subtype 5 (CLN5) Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Jan 2024

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At a glance

  • Drugs NGN-101 (Primary) ; NGN-101 (Primary)
  • Indications Neuronal ceroid lipofuscinosis
  • Focus Adverse reactions; First in man
  • Acronyms CLN5-200
  • Sponsors Neurogene Inc
  • Most Recent Events

    • 05 Jan 2024 According to a Neurogene media release, Neurogene has completed enrollment of Cohorts 1 and 2 in this study and is currently enrolling a final higher dose cohort.
    • 05 Jan 2024 According to a Neurogene media release, company is in discussions with U.S. Food and Drug Administration (FDA) regarding a streamlined registrational pathway for NGN-101 in 2H:24
    • 18 Jul 2023 According to a Neurogene media release, preliminary/interim data from this study is expected in the second half of 2024.
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