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A randomized Phase 2b/3 proof of concept study of AZP2006 in Progressive-supranuclear-palsy

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Trial Profile

A randomized Phase 2b/3 proof of concept study of AZP2006 in Progressive-supranuclear-palsy

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs Ezeprogind (Primary)
  • Indications Progressive supranuclear palsy
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms PROMISE-PSP

    • Most Recent Events

    • 15 Mar 2024 New trial record
    • 13 Mar 2024 According to an Alzprotect media release, the feedback from both the American (FDA) and European (EMA) authorities has armed Alzprotect with a valuable roadmap, enabling the refinement of the intended Phase 2/3 study protocol to ensure seamless alignment with scientific standards and regulatory requirements.
    • 13 Mar 2024 According to an Alzprotect media release, company plans to initiate a randomized Phase 2b/3 proof of concept for PSP scheduled to commence in late 2024, is set to deliver outcomes that align with scientific and regulatory expectations across the United States and the European Union. Company has received favorable feedback from both the American (FDA) and European (EMA) authorities regarding the regulatory path for advancing the clinical development of Ezeprogind (AZP2006) for patients with PSP.

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