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A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

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A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2025

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At a glance

  • Drugs Ribitol (Primary)
  • Indications Limb girdle muscular dystrophies
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Fortify
  • Sponsors ML Bio Solutions

    • Most Recent Events

    • 13 Jan 2025 According to a BridgeBio Pharma media release, the trial is fully enrolled with 112 patients. The Company expects Last Patient - Last Visit (LPLV) and topline readout of the interim analysis cohort in second half 2025.
    • 30 Sep 2024 According to a BridgeBio Pharma media release, company completes enrollment patients of this study and company also believes there is an opportunity to pursue Accelerated Approval in the U.S. for BBP-418 in LGMD2I/R9 based on a potential biomarker surrogate endpoint of glycosylated alpha-dystroglycan at time of the interim analysis.
    • 27 Sep 2024 Status changed from recruiting to active, no longer recruiting.

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