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Phase 3 study of FLT201 for Gaucher Disease Type 1

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Trial Profile

Phase 3 study of FLT201 for Gaucher Disease Type 1

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2025

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At a glance

  • Drugs FLT 201 (Primary)
  • Indications Gaucher's disease type I
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 03 Feb 2025 According to a Spur Therapeutics media release, Full approval would be based on a primary endpoint of maintenance or improvement in hemoglobin at one year in the Phase 3 study.
    • 03 Feb 2025 According to a Spur Therapeutics media release, Company announced positive feedback from its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting its planned Phase 3 trial for FLT201, supported by data from GALILEO-1. d on alignment with the FDA, Spur expects the Phase 3 trial will be a single-arm study in adults with Gaucher disease type 1, similar in design to GALILEO-1.
    • 03 Feb 2025 According to a Spur Therapeutics media release, Company expected to start and dose the first patient in a Phase 3 trial of FLT201 in the second half of 2025. company actively preparing and expects to complete site selection this month, with more than 45 sites across the United States, Canada, the United Kingdom, Europe, Israel and Latin America.

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