A phase 2b/3 global pivotal study in Prosthetic Joint Infections
Latest Information Update: 21 May 2024
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
- 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