Phaxiam Therapeutics has received Investigational New Drug (IND) approval from the FDA for its Phase II GLORIA study, a significant step in developing phage therapy for Prosthetic Joint Infections (PJI) caused by Staphylococcus aureus. The GLORIA study is set to be the first worldwide multicenter, randomized, placebo-controlled trial of phage therapy for PJI.
The GLORIA study will enroll 100 patients with PJI following hip or knee replacement who require open surgical debridement (DAIR). Participants will be treated with Phaxiam's anti-S. aureus phages or a placebo, in conjunction with antibiotics. The trial will be conducted across 7 European countries (France, Germany, UK, Spain, Italy, Netherlands, Sweden) and the United States.
PJI is a severe complication affecting tens of thousands of patients annually in Western countries, with current treatments failing in approximately 50% of cases. These failures often lead to reinfection (60%), amputation (11%), and a 25% mortality rate within five years. The economic burden of PJI is also substantial, with high treatment costs straining healthcare systems. The US market for anti-S. aureus phages in PJI is estimated at €600-700 million.
Phaxiam Therapeutics is leveraging its leadership position in phage therapy, supported by clinical data from compassionate use cases involving locally administered anti-S. aureus phages. These cases have demonstrated a favorable safety profile and clinical benefits. The company has identified 5 clinical centers and aims to include 10 participating centers to optimize patient recruitment.
"This FDA IND clearance is a major recognition of our therapeutic approach and of our whole platform," said Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics. "This is the first time that PHAXIAM will be in a position to conduct clinical development in the United States, and we look forward to moving ahead in the collaboration with the participating centers already identified."
Pending successful completion of the GLORIA study, anticipated in Q3 2026, Phaxiam Therapeutics may pursue an early access process and Conditional Market Approval (CMA), potentially enabling pre-commercialization in Europe by the second half of 2027. The clinical protocol is also being submitted to European health authorities and the MHRA in the UK. Patient recruitment is scheduled to commence in Q1 2025.
