Phaxiam Therapeutics is making strides in the development of phage therapy, with the planned initiation of the GLORIA global Phase II study in the first quarter of 2025. This study will investigate the use of phage therapy for prosthetic joint infections (PJI) related to Staphylococcus aureus. The company's financial stability is supported by €5.7 million in cash and cash equivalents as of September 30, 2024.
GLORIA Phase II Study
The GLORIA study marks a significant step forward as the first global bacteriophage study targeting Staphylococcus aureus-related PJI. The U.S. FDA has already approved the study protocol, and the company is actively preparing for patient recruitment. This Phase II trial aims to evaluate the efficacy and safety of Phaxiam's phage therapy in patients with PJI, a condition with limited treatment options and significant morbidity.
Financial Position and Future Milestones
Phaxiam's current cash reserves are expected to fund its programs and operating expenses until March 2025. The company is actively exploring additional financing options, including cost reduction measures and strategic investor commitments, to extend its financial runway. Key milestones expected in the next 12 months include:
- Clinical outcomes from compassionate real-life treatments and the PhagoDAIR pilot study, expected before the end of 2024.
- Phase II (PHRC) study in Diabetic Foot Ulcer (DFU): first patient enrollment expected in the fourth quarter of 2024.
- GLORIA Global Phase II study: clearance (CTA) from European and UK (MHRA) regulatory authorities to initiate patient enrollment in Europe.
- Preliminary results from the Phase I pharmacokinetic study in endocarditis expected around mid-2025.
Expanding the Phage Therapy Pipeline
In addition to the GLORIA study, Phaxiam is advancing a Phase II study in Diabetic Foot Ulcers (DFU), with the first patient enrollment anticipated in the fourth quarter of 2024. The company also expects preliminary results from a Phase I pharmacokinetic study in endocarditis around mid-2025. These studies are part of Phaxiam's broader strategy to develop phage-based treatments for severe and resistant bacterial infections.
Phaxiam's Focus on Resistant Infections
Phaxiam Therapeutics is focused on developing innovative treatments for resistant bacterial infections using phages, natural bacterial-killing viruses. The company's portfolio targets three of the most resistant and dangerous bacteria: Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa, which together account for more than two-thirds of resistant hospital-acquired infections.
Management Commentary
"The third quarter of 2024 was marked by the steady execution of our clinical roadmap. Our recent efforts have culminated in the U.S. FDA approval of the GLORIA Phase II study protocol, the first global bacteriophage study targeting prosthetic joint infections related to Staphylococcus aureus. We are actively working on the launch of patients recruitment for this strategic study in the first quarter of 2025, as planned," stated Thibaut du Fayet, Chief Executive Officer of PHAXIAM.
