Phaxiam: FDA green light for Phase II study

(CercleFinance.com) - PHAXIAM Therapeutics announces that it has received FDA approval for an Investigational New Drug (IND) application for its Phase II study in osteoarticular prosthesis infections (PJI) caused by Staphylococcus aureus (S.
aureus).

Named 'GLORIA', this study is PHAXIAM's most strategic asset, with the highest priority.It plans to include 100 patients with PJI (hip or knee prosthesis) undergoing open surgical debridement (DAIR), who will be treated with PHAXIAM's anti-S. aureus phages or a placebo, in combination with antibiotics.

FDA approval is a major step forward in the deployment of PHAXIAM's international clinical strategy. The company has already identified 5 clinical centers and intends to reach 10 participating centers to ensure optimal territorial coverage for study recruitment.

Subject to the success of the GLORIA study, scheduled for completion in Q3 2026, PHAXIAM could be eligible for an early access process and consider a Conditional Marketing Authorization (CMA), paving the way for pre-commercialization in Europe as early as H2 2027.


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