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A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease Compared With Alglucosidase Alfa/Placebo

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Trial Profile

A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease Compared With Alglucosidase Alfa/Placebo

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2024

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At a glance

  • Drugs Cipaglucosidase alfa (Primary) ; Miglustat (Primary) ; Alglucosidase alfa
  • Indications Glycogen storage disease type II
  • Focus Registrational; Therapeutic Use
  • Acronyms PROPEL
  • Sponsors Amicus Therapeutics

    • Most Recent Events

    • 01 Feb 2024 According to an Amicus Therapeutics media release, data from this study will be presented at the 20th Annual WORLDSymposium™ 2024, being held February 4-9, 2024 in San Diego, CA.
    • 28 Sep 2023 According to an Amicus Therapeutics media release, announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules for adults living with late-onset Pompe disease (LOPD).The FDA approval was based on clinical data observed from this trial.
    • 29 Aug 2023 According to an Amicus Therapeutics media release, data from this study will be presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023, being held August 29 - September 1, 2023 in Jerusalem, Israel.
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