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FLT 201

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Drug Profile

FLT 201

Alternative Names: FLT-200; FLT-201; FLT200/201

Latest Information Update: 11 Feb 2025

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At a glance

  • Originator University College London
  • Developer Spur Therapeutics
  • Class Gene therapies
  • Mechanism of Action Gene transference; Glucosylceramidase replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Gaucher's disease type I
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Gaucher's disease type I

Most Recent Events

  • 04 Feb 2025 Spur Therapeutics receives US FDA alignment from its end-of-phase 2 (EOP2) meeting with the US FDA for Phase III trial design for FLT 201 for the treatment of Gaucher's disease type I
  • 04 Feb 2025 Efficacy and adverse events data from the phase I/II GALILEO-1 trial in Gaucher’s disease type I released by Spur Therapeutics
  • 04 Feb 2025 Spur Therapeutics completes the phase-I/II GALILEO-1 trial for Gaucher's disease in Brazil, Germany, Israel, Spain, the UK and US (IV, Infusion) (NCT05324943)

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