Phaxiam Therapeutics has received Investigational New Drug (IND) approval from the FDA to initiate its Phase II GLORIA study. This trial will assess the efficacy of phage therapy in treating Prosthetic Joint Infections (PJI) caused by Staphylococcus aureus. The GLORIA study marks a significant step forward as the first worldwide multicenter, randomized, placebo-controlled trial of phage therapy for PJI.
The GLORIA study aims to enroll 100 patients with PJI affecting hip or knee replacements. Participants will undergo open surgical debridement (DAIR) and receive either Phaxiam's anti-S. aureus phages or a placebo, in conjunction with antibiotics. The study will be conducted across multiple centers in the United States and Europe.
High Unmet Need in Prosthetic Joint Infections
Prosthetic Joint Infection (PJI) represents a severe complication following hip and knee replacement surgeries. In Western countries, there are approximately 50,000 to 60,000 new cases annually. Current standards of care exhibit a failure rate of 50%, with reinfection rates as high as 60%, amputation risks at 11%, and a five-year mortality rate of 25%. The economic burden on healthcare systems is substantial, further emphasizing the need for improved treatment options. The US market for anti-S. aureus phages in PJI is estimated at €600-700 million.
Phage Therapy as a Promising Solution
Phage therapy offers a promising alternative for combating bacterial infections, particularly those resistant to conventional antibiotics. Phaxiam Therapeutics has established a leading position in this field, 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.
Study Design and Timeline
The GLORIA study will be conducted in 7 European countries (France, Germany, UK, Spain, Italy, Netherlands, Sweden) and the United States. Professor Tristan Ferry, coordinator of the Reference Center for Complex Osteoarticular Infections (CRIOAC) at the Croix-Rousse Hospital (HCL, Lyon), will serve as the principal investigator.
Patient recruitment is scheduled to commence in Q1 2025, with clinical data readout anticipated in Q3 2026. Successful completion of the GLORIA study could potentially lead to an early access process and Conditional Market Approval (CMA) in Europe as early as the second half of 2027.
Management Commentary
Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics, stated, "This FDA IND clearance is a major recognition of our therapeutic approach and of our whole platform... With these strategic advances, we are about to reinforce our position as a leader in phage therapy for Prosthetic Joint Infection, a critical indication with high worldwide incidence and critical unmet medical needs."
