PHAXIAM Therapeutics a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, announces that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for its Phase II study, GLORIA, in prosthetic joint infections (PJI) caused by Staphylococcus aureus ( S. aureus ) .  

The GLORIA study is PHAXIAM’s most strategic asset, with the highest priority. It is the
first global (Europe and the United States) proof-of-concept, multicenter, randomized, placebo-controlled study of phage therapy in PJI. The study plans to include 100 patients with PJI (hip or knee replacement) undergoing open surgical debridement (OSD), who will be treated with PHAXIAM’s anti- S. aureus phages or placebo, in combination with antibiotics.

PJI is a severe complication affecting thousands of patients who have undergone hip or knee replacement, with 50,000 to 60,000 new cases per year in Western countries 1 . The unmet medical need is considerable as current standards of care show a failure rate of 50%, with high risks of reinfection (60%), amputation (11%) and mortality (25% at five years). In addition, treatment costs are high and represent a heavy burden on healthcare systems. In the United States, the incidence of patients is three times higher than in European patients, with a price gap of 25 to 30% for treatment. The market for PJI treatment with anti -S. aureus phages in the United States is estimated at between 600 and 700 million euros 2 .

Phage therapy represents a promising solution in this context and PHAXIAM benefits from a leading position in this indication. This status is supported by robust clinical data from several dozen patients treated in real life in the compassionate setting with locally administered anti- S. aureus phages , giving the treatment a very good safety profile and already showing clinical benefits.

The IND approval received from the US FDA on the GLORIA study protocol 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 in order to ensure an optimal territorial network for the study recruitment.

Based on the structuring discussions with the US FDA, PHAXIAM is also about to finalize the filing of the clinical protocol with the main European health authorities 3 , including the British MHRA. Subject to these approvals, the GLORIA study will be conducted in 7 European countries (France, Germany, United Kingdom, Spain, Italy, Netherlands, Sweden) and in the United States, which will make it the most robust phage therapy study in the world.

Professor Tristan Ferry, coordinator of the Reference Center for Complex Osteoarticular Infections (CRIOAC) at the Croix-Rousse Hospital (HCL, Lyon) and an internationally recognized expert in phage therapy, will be the principal investigator of the study.

Subject to the success of the GLORIA study, which is scheduled to be completed in the 3rd quarter of 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 the 2nd half of 2027.

Thibaut du Fayet, CEO of PHAXIAM Therapeutics, said: “This approval from the US FDA is a major recognition of our therapeutic approach and our entire platform. It is a key milestone in our strategic program on S. aureus and I would like to thank all of our teams who contributed to this success. This is the first time that PHAXIAM will be able to conduct clinical development in the United States and we look forward to continuing the collaboration with the participating centers already identified. In parallel, we are finalizing the submission of the GLORIA protocol to the European authorities, with the aim of obtaining authorizations in 7 countries of the European Union and the United Kingdom in the coming weeks. The confirmed objective remains to be able to start recruitment for this first global study in phage therapy during the first quarter of 2025, as previously announced.” With these strategic advances, we are strengthening our leadership position in phage therapy for osteoarticular infections on prostheses, a critical indication with a high global incidence and unmet medical needs. The GLORIA study could be the first study worldwide to provide a robust clinical proof of concept for phages, with 100 patients included. Based on the extensive compassionate clinical data already generated in real-world conditions, we believe that the probability of success of this trial is quite high. We remain committed to providing a major solution and hope to many patients in a therapeutic impasse situation .

 

Source: globenewswire.com

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