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A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase Alfa in Treatment naïve Patients With Late-onset Pompe Disease

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A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase Alfa in Treatment naïve Patients With Late-onset Pompe Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2024

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At a glance

  • Drugs Avalglucosidase alfa (Primary) ; Alglucosidase alfa
  • Indications Glycogen storage disease type II
  • Focus Registrational; Therapeutic Use
  • Acronyms COMET
  • Sponsors Genzyme Corporation - Medtronic (JV); Sanofi; Sanofi Genzyme

    • Most Recent Events

    • 05 Feb 2024 Results presented in a Sanofi Media Release.
    • 01 Dec 2023 Population PK (PopPK) analysis was performed using nonlinear mixed effect modeling approach on pooled data from three clinical trials (NCT01898364, NCT02032524 and NCT02782741) with LOPD patients, and a phase 2 study (NCT03019406) with infantile-onset Pompe disease patients to propose alternative dosing regimens for pediatric LOPD patients based on a bodyweight cut-off,, published in the Journal of Pharmacokinetics and Pharmacodynamics.
    • 06 Oct 2023 According to a Sanofi - Aventis media release, data from this study were presented at the 28th Annual Congress of the World Muscle Society (WMS).

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