A Phase 2 study sponsored by Assistance Publique – H?pitaux de Paris (AP-HP) as part of the hospital-based clinical research program (PHRC)
Evaluation of the efficacy of a local treatment with PHAXIAM’s anti-S. aureus phages added to the standard treatment by surgery and antibiotics
80 patients to be enrolled in 27 French clinical centers
Validation of the study protocol by the ANSM expected in H1 2025
Lyon (France), October 9, 2024 – 06:00pm CEST - PHAXIAM Therapeutics (Euronext: PHXM - FR0011471135), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, today announces the validation, as part of the French Hospital Clinical Research Program (PHRC), of a new Instigator-sponsored trial (IST), PHAGOSCARPA, in extra-cavitary vascular grafts implant infections caused by Staphylococcus aureus (S. aureus).
The number of vascular prostheses is increasing every year and vascular graft infection occurs in 1-5% of patients. Staphylococcus aureus is the most common bacterium involved (20-53%) in extra-cavitary (EC) vascular graft infection (VGI). The mortality rate is very high and estimated at 10-25% within 30 days after diagnosis and over 50% after 1 year. The risk of amputation ranges from 4 to 14%. These infections are difficult to eradicate due to biofilm formation and increasing antimicrobial resistance. The standard of care (SoC) includes surgical detersion of the surgical site and vascular graft with prolonged antibiotic treatment. VGI are difficult and costly to treat, despite advances in antibiotic management and new operative techniques.
Satisfactory results have been obtained for the compassionate clinical use of PHAXIAM’s phage therapy for vascular graft infection when conventional treatment has failed. Lytic phages, unaffected by resistance to anti-S. aureus antibiotics, can be used in combination with antibiotics and have a rapid bactericidal and synergistic action against biofilm. Phage tolerance was good, with no signs of local or systemic toxicity, in clinical case series.
Based on these promising results, PHAGOSCARPA was designed as a multicentric, randomized and blinded phase 2 study to evaluate the efficacy of PHAXIAM’s anti-S. aureus phages administered locally vs. SoC.
The primary endpoint consists in the therapeutic success rate at 3 months, including:
absence of clinical signs of infection (T°C≤38.0°C; no local inflammation),
normal graft function (no infection-related bleeding, ischemia distal, major amputation),
absence of radiological evidence of infection on CT, with no other explanatory causes identified.
Sponsored by Assistance Publique – H?pitaux de Paris (AP-HP), the study received the approval from the Hospital Clinical Research Program and the Scientific Council of the National Network for Clinical Research in Infectious Diseases. The study plans to enrol 80 patients, recruited across 27 French clinical centers. The inclusion period is estimated at 24 months, with a patient follow-up for a further 12 months, i.e. an overall study duration of 36 months. The launch of the study is subject to validation of its clinical protocol by the French health authority (ANSM), expected in the first half of 2025. PHAXIAM is committed to ensuring the supply of the clinical doses required for the conduct of the study and will negotiate with the sponsor for access to the clinical data generated by this phase 2 trial.
Sylvain Diamantis, MD, Head of the Infectious and Tropical Diseases Department at Melun Hospital and Principal Investigator of the study, stated: "We are very pleased with the work carried out in preparation for this study involving 27 French clinical centers and targeting a severe resistant infection. The number of vascular graft implants increases every year and Staphylococcus aureus is the most common bacterium involved in case of graft infection. We think that the use of phage therapy in combination with standard treatment could contribute to improve the treatment of patients who often face a therapeutic impasse, and we are thrilled to start this new trial.”
Pascal Birman, MD, Chief Medical Officer of PHAXIAM, concluded: "This validation of a new investigational-sponsored trial, based on the data from compassionate treatments, once again reflects the added value that phage therapy could bring to the treatment of severe and resistant bacterial infections. We are proud to support the AP-HP in this study by providing clinical batches of our anti-S. aureus phages which have already shown promising results in compassionate use. We look forward to starting as soon as possible the enrolment in this new indication with high unmet medical needs.”
As a reminder, two other investigator-sponsored trials, in which PHAXIAM is involved, are also planned in high-value indications:
Phase 2 study (60 patients) in Diabetic Foot Ulcer (DFU) sponsored by N?mes Hospital (France), targeting DFU infections due to mono-bacterial S. aureus infection and ready for First Patient-In, expected before the end of 2024.
Phase 2 study (180 patients) targeting nosocomial pulmonary infections due to P. aeruginosa, sponsored by La Pitié Salpêtrière Hospital in Paris (France), including patients with ventilator-associated pneumopathies (VAP). The filing of this study is planned in France (ANSM) in Q1 2025.
About PHAXIAM Therapeutics
PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.
PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
NewCap Mathilde Bohin / Du?an Ore?ansky Investor Relations Arthur Rouillé Media Relations +33 1 44 71 94 94 [email protected]
Forward-looking information
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