相关临床试验
8
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
2
25.0%
已完成
2
25.0%
尚未招募
2
25.0%
招募中
2
25.0%
暂无批准数据
• 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 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 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 reports €5.7 million in cash and cash equivalents as of September 30, 2024, supporting operations until March 2025. • The GLORIA global Phase II study, targeting prosthetic joint infections related to _Staphylococcus aureus_, is set to begin in Q1 2025 after FDA approval. • 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, further demonstrating phage therapy's potential.
• 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.
• 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 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 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' 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 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.
