Phaxiam Therapeutics Advances Phage Therapy for Resistant Bacterial Infections
Key Insights
Phaxiam Therapeutics is focused on developing phage (search) therapies for severe, resistant bacterial infections, particularly Prosthetic Joint Infections (search) (PJI).
The company anticipates filing an Investigational New Drug (IND) application in the U.S. and a Clinical Trial Application (CTA) in Europe for its GLORIA Phase II study in Q4 2024.
Phaxiam's GLORIA study, expected to launch in Q1 2025, will evaluate phage (search) therapy for Staphylococcus aureus (search) infections in PJI patients.
Phaxiam Therapeutics is making strides in the development of phage (search) therapies to combat severe and resistant bacterial infections. The company's lead program targets Prosthetic Joint Infections (search) (PJI) caused by Staphylococcus aureus (search), addressing a critical unmet need in patients who have failed traditional antimicrobial treatments. Phaxiam anticipates significant clinical readouts and regulatory submissions in the coming months, potentially paving the way for early access to these innovative therapies.
Advancing Clinical Programs
Phaxiam's strategy focuses on high-value indications with significant medical needs. The S. aureus program is at the forefront, aiming to provide a therapeutic solution for complex mono-bacterial infections. Promising signals from compassionate treatments, involving over 120 patients, have informed the design of the GLORIA Phase II study.
The GLORIA study is a multicenter, randomized, comparative trial expected to enroll 100 patients in Europe and the U.S. It will assess the efficacy of phage (search) therapy in PJI patients undergoing open-surgery debridement (DAIR) in combination with antibiotics (search). The Investigational New Drug Application (IND) and Clinical Trial Application (CTA) are expected to be filed imminently, with potential approval anticipated in Q4 2024, allowing for patient enrollment to begin in Q1 2025.
Thibaut du Fayet, Chief Executive Officer of PHAXIAM, stated, "Since the beginning of 2024, all PHAXIAM teams have been very committed and focused on the submission of the GLORIA Phase II study protocol to the American and European authorities and on the preparation of the launch of this study, expected in the first quarter of 2025."
Expanding Phage Therapy Applications
Beyond PJI, Phaxiam is also exploring phage (search) therapy for Endocarditis Infections (EI) and complex mono-bacterial Escherichia coli (search) infections. A Phase I PK study in EI is ongoing, with initial results expected around mid-2025. Additionally, a Phase I PK study for E. coli infections in the urinary tract has been validated and is ready for enrollment.
Compassionate treatments have provided valuable real-world data, with infection control at 3 months reaching approximately 80% in PJI patients treated with Phaxiam phages. This is considered a significant improvement over the standard of care in this challenging patient population.
Financial Update
Phaxiam reported a net loss of €10.6 million for the first half of 2024, compared to a net loss of €12.2 million for the same period in 2023. As of June 30, 2024, the company had €1.5 million in cash and cash equivalents. A capital increase in early July 2024 boosted the cash position by €6.8 million.
The company believes its current cash position can fund existing programs into March 2025 and is exploring options to extend financial visibility.
Upcoming Milestones
Key milestones expected over the next 12 months include:
- First-Patient-In for a Phase II Investigator-Sponsored Trial (IST) in Diabetic Foot Ulcer (DFU) expected in Q4 2024.
- Clinical readout from the PhagoDAIR pilot study expected before the end of 2024.
- Validation of the GLORIA global Phase II IND and CTA expected in Q4 2024.
- First-Patient-In for the GLORIA global Phase II study expected in Q1 2025.
- First readout from the Endocarditis Phase I PK study expected around mid-2025.