Phaxiam Therapeutics is advancing its clinical strategy in developing innovative treatments for severe and resistant bacterial infections. The company's lead program, the GLORIA Phase II study, has received U.S. FDA approval and is expected to begin patient recruitment in the first quarter of 2025. This global study will evaluate phage therapy for prosthetic joint infections related to Staphylococcus aureus.
Financial Position
As of September 30, 2024, Phaxiam reported €5.7 million in cash and cash equivalents, compared to €1.5 million as of June 30, 2024. This financial position is expected to fund existing programs and operating expenses until March 2025. The company is actively exploring additional funding options, including cost reduction measures and strategic investor commitments, to extend its cash runway.
Clinical Development
Phaxiam is making strides in its clinical pipeline with several key milestones expected in the next 12 months:
- GLORIA Phase II Study: The company anticipates clearance from European and UK (MHRA) regulatory authorities to initiate patient enrollment in Europe for the GLORIA study.
- Diabetic Foot Ulcer (DFU) Study: A Phase II (PHRC) study in Diabetic Foot Ulcer is expected to enroll its first patient in the fourth quarter of 2024.
- Endocarditis Study: Preliminary results from the Phase I pharmacokinetic study in endocarditis are expected around mid-2025.
- Compassionate Real-Life Treatments: Clinical outcomes from updated compassionate real-life treatments and the PhagoDAIR pilot study are expected before the end of 2024.
Phage Therapy Approach
Phaxiam is focused on developing treatments based on 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. These bacteria 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," stated Thibaut du Fayet, Chief Executive Officer of PHAXIAM. "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."
