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Phase 1/2 trial of PBML04 for treatment of metachromatic leukodystrophy

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Phase 1/2 trial of PBML04 for treatment of metachromatic leukodystrophy

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 16 Aug 2024

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At a glance

  • Drugs PBML 04 (Primary)
  • Indications Metachromatic leukodystrophy
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Passage Bio

    • Most Recent Events

    • 08 Aug 2024 According to a Passage Bio media release, following a restructuring of the original agreement of Passage Bio with the University of Pennsylvania about its Gene Therapy Program, a research, collaboration, and license agreement with GEMMA Biotherapeutics was finalized. Consequently, GEMMA Biotherapeutics received an exclusive, worldwide license for all future development of PBML-04 for the treatment of metachromatic leukodystrophy, and 2 other drugs.
    • 08 Jun 2022 According to Passage Bio media release, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PBML04, that is being studied for the treatment of Metachromatic Leukodystrophy.
    • 14 Jan 2022 New trial record

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