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A phase 2b/3 global pivotal study in Prosthetic Joint Infections

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Trial Profile

A phase 2b/3 global pivotal study in Prosthetic Joint Infections

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 21 May 2024

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At a glance

  • Drugs PP 1493 (Primary) ; PP 1815 (Primary) ; Antibacterials
  • Indications Bone and joint infections; Staphylococcal infections
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors PHAXIAM Therapeutics

    • Most Recent Events

    • 15 May 2024 According to a PHAXIAM Therapeutics media release, company confirms its objective to file a Clinical Trial Application (CTA) with the EMA and the FDA in 3Q 2024 in view of starting patient enrollment in early 2025. Global Phase 2 study in PJI Regulatory Approval anticipated in 4Q 2024.
    • 15 May 2024 According to a PHAXIAM Therapeutics media release, company is accelerating this PJI clinical development efforts through active preparations of a global Phase 2 proof-of-concept (POC) study and intended to be a multicentric, randomized, double-blind trial and is expected to include 100 patients in Europe and the US. Launch of the global Phase 2 study in PJI anticipated in 1Q 2025.
    • 29 Sep 2023 New trial record

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