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A single, randomized, double-blind, placebo-controlled trial of bitopertin for the treatment of Erythropoietic Protoporphyria (EPP)

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Trial Profile

A single, randomized, double-blind, placebo-controlled trial of bitopertin for the treatment of Erythropoietic Protoporphyria (EPP)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2024

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At a glance

  • Drugs Bitopertin (Primary)
  • Indications Erythropoietic protoporphyria
  • Focus Therapeutic Use
  • Acronyms APOLLO

    • Most Recent Events

    • 06 Nov 2024 New trial record
    • 04 Nov 2024 According to the Disc Medicine Media Release, Disc would have the potential to submit an NDA based on the existing data package and the APOLLO trial would serve as a confirmatory trial. Disc will be meeting with the FDA to finalize the details of APOLLO and plans to provide an update in Q1 2025 on this discussion as well as timing for NDA filing under an accelerated pathway.
    • 04 Nov 2024 According to the Disc Medicine Media Release, company to file an accelerated approval based on existing data and utilizing reduction of PPIX as a surrogate endpoint.

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