Phaxiam Therapeutics' PhagoDAIR Study Shows Promising Infection Control with Phage Therapy
• Phaxiam Therapeutics' PhagoDAIR pilot study demonstrated a 74% infection control rate in the phage therapy arm for patients with Staphylococcus aureus prosthetic joint infections (PJI).
• The study confirmed the safety of intra-articular phage administration, with tolerance analysis showing no significant adverse events related to the treatment.
• A consolidated infection control rate of 80% was achieved when including patients who received rescue phage therapy after initial treatment failure.
• Phaxiam is advancing phage therapy with the GLORIA Phase II study, a global trial set to begin in Q1 2025, building on insights from PhagoDAIR.
Phaxiam Therapeutics Advances Phage Therapy for Resistant Bacterial Infections
• Phaxiam Therapeutics reported €5.7 million in cash and cash equivalents as of September 30, 2024, supporting operations until March 2025.
• The company's GLORIA Phase II study, a global bacteriophage study targeting Staphylococcus aureus prosthetic joint infections, is set to begin in Q1 2025.
• A Phase II study in Diabetic Foot Ulcers is expected to enroll its first patient in Q4 2024, expanding Phaxiam's clinical pipeline.
• Preliminary results from a Phase I pharmacokinetic study in endocarditis are anticipated around mid-2025, marking progress in phage therapy development.
Phaxiam Therapeutics Announces Q3 2024 Financial Results and Clinical Milestone Updates
• Phaxiam Therapeutics reported €5.7 million in cash and equivalents as of September 30, 2024, following a €7.8 million capital increase, extending the cash runway to March 2025.
• The company anticipates key milestones, including clinical outcomes from compassionate treatments and the PhagoDAIR pilot study by the end of 2024.
• Phaxiam plans to initiate patient enrollment in the Phase II Diabetic Foot Ulcer study in Q4 2024 and the GLORIA Phase II study for prosthetic joint infections in Q1 2025.
• Preliminary results from the Phase I endocarditis study are expected around mid-2025, marking continued progress in Phaxiam's clinical development pipeline.
Phaxiam Therapeutics' Phage Therapy Receives FDA Clearance for Phase II PJI Trial
• Phaxiam Therapeutics received FDA clearance for its Phase II GLORIA study, evaluating phage therapy for Staphylococcus aureus-related Prosthetic Joint Infections (PJI).
• The GLORIA study is a multicenter, randomized, placebo-controlled trial assessing the efficacy of Phaxiam's anti-S. aureus phages in combination with antibiotics for PJI treatment.
• Patient recruitment is scheduled to begin in Q1 2025, with clinical data readout expected in Q3 2026, potentially leading to early access and conditional market approval in Europe.
• The study will enroll 100 patients across the US and Europe, making it the most robust phage therapy study in the world.
FDA Approves Phaxiam Therapeutics' Phase II Trial for Staphylococcus aureus Prosthetic Joint Infections
• Phaxiam Therapeutics received FDA approval for its Investigational New Drug (IND) application to conduct a Phase II study, named 'GLORIA', targeting osteoarticular prosthesis infections (PJI) caused by *Staphylococcus aureus*.
• The GLORIA study will enroll 100 patients with hip or knee PJI undergoing open surgical debridement (DAIR), evaluating Phaxiam's anti-*S. aureus* phages in combination with antibiotics versus placebo plus antibiotics.
• This FDA approval marks a significant advancement in Phaxiam's international clinical strategy, with plans to activate 10 clinical centers to optimize patient recruitment for the study.
• If the GLORIA study succeeds, which is expected to be completed in Q3 2026, Phaxiam may pursue Conditional Marketing Authorization (CMA) in Europe, potentially enabling pre-commercialization by H2 2027.
Phaxiam Therapeutics Receives FDA Clearance for Phase II Phage Therapy Study in Prosthetic Joint Infections
• Phaxiam Therapeutics received FDA clearance for its Phase II GLORIA study, evaluating phage therapy for Staphylococcus aureus-related Prosthetic Joint Infections (PJI).
• The GLORIA study is a multicenter, randomized, placebo-controlled trial that will enroll 100 PJI patients undergoing open surgical debridement.
• Patient recruitment is scheduled to begin in Q1 2025, with clinical data readout expected in Q3 2026, potentially leading to early access and conditional market approval.
• The study protocol is also being submitted to European health authorities and the MHRA in the UK, expanding the trial's global reach.
Phaxiam Therapeutics Receives FDA Clearance for Phase II Phage Therapy Study in Prosthetic Joint Infections
• Phaxiam Therapeutics received FDA clearance to begin its Phase II GLORIA study, which will assess phage therapy for Staphylococcus aureus-related Prosthetic Joint Infections (PJI).
• The GLORIA study is a multicenter, randomized, placebo-controlled trial evaluating anti-S. aureus phages in combination with antibiotics for PJI patients undergoing open surgical debridement.
• Patient recruitment is scheduled to begin in Q1 2025, with clinical data expected in Q3 2026; the study will be conducted in the US and several European countries.
• The trial aims to address the high failure rate of current PJI treatments, which often lead to reinfection, amputation, and mortality, representing a significant unmet medical need.
Phaxiam Therapeutics Advances Phage Therapy with Phase 2 Trial for Staphylococcus aureus Vascular Graft Infections
• Phaxiam Therapeutics' PHAGOSCARPA, a phase 2 study, will assess anti-S. aureus phages for treating extra-cavitary vascular graft implant infections.
• The trial, involving 80 patients across 27 French centers, aims to improve outcomes where mortality rates range from 10-25% within 30 days.
• The primary endpoint is the therapeutic success rate at 3 months, evaluating clinical, functional, and radiological infection signs.
• ANSM validation is expected in H1 2025, with Phaxiam supplying clinical doses and negotiating data access for potential future commercialization.
Phaxiam Therapeutics Advances Phage Therapy for Resistant Bacterial Infections
• Phaxiam Therapeutics is focused on developing phage therapies for severe, resistant bacterial infections, particularly Prosthetic Joint Infections (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 therapy for Staphylococcus aureus infections in PJI patients.
• Preliminary data from the PhagoDAIR pilot study are expected by the end of 2024, with complementary data anticipated in 2025.
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