Phaxiam Therapeutics has announced the validation of PHAGOSCARPA, a new investigator-initiated phase 2 study evaluating the efficacy of its anti- Staphylococcus aureus phages in treating extra-cavitary vascular graft implant infections. Sponsored by Assistance Publique – Hôpitaux de Paris (AP-HP), the trial aims to address a critical unmet need in patients facing high mortality rates and limited treatment options for these severe infections. The study plans to enroll 80 patients across 27 French clinical centers, with the primary endpoint being the therapeutic success rate at 3 months.
Vascular graft infections (VGIs) pose a significant clinical challenge, with Staphylococcus aureus being the most common causative bacterium, accounting for 20-53% of cases. These infections are associated with mortality rates of 10-25% within 30 days of diagnosis and exceeding 50% after one year. The current standard of care involves surgical debridement and prolonged antibiotic treatment; however, these infections are difficult to eradicate due to biofilm formation and increasing antimicrobial resistance.
PHAGOSCARPA Trial Design and Objectives
PHAGOSCARPA is designed as a multicentric, randomized, and blinded phase 2 study. It will evaluate the efficacy of locally administered Phaxiam's anti-S. aureus phages in combination with the standard of care, compared to the standard of care alone. The primary endpoint focuses on the therapeutic success rate at 3 months, defined by the 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), and absence of radiological evidence of infection on CT scans.
The study's design has garnered support from the Hospital Clinical Research Program and the Scientific Council of the National Network for Clinical Research in Infectious Diseases. The inclusion period is estimated at 24 months, followed by a 12-month patient follow-up, resulting in a total study duration of 36 months. Validation of the clinical protocol by the French health authority (ANSM) is anticipated in the first half of 2025. Phaxiam Therapeutics will supply the necessary clinical doses and negotiate access to the clinical data generated during the trial.
Expert Commentary
Sylvain Diamantis, MD, Head of the Infectious and Tropical Diseases Department at Melun Hospital and the study's Principal Investigator, expressed enthusiasm for the trial, stating, "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... 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, highlighted the potential of phage therapy, noting, "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 look forward to starting as soon as possible the enrolment in this new indication with high unmet medical needs."
Expanding Clinical Program
Phaxiam Therapeutics is also involved in two other investigator-sponsored trials: a phase 2 study in Diabetic Foot Ulcer (DFU) targeting infections due to mono-bacterial S. aureus, with the First Patient-In expected before the end of 2024, and a phase 2 study targeting nosocomial pulmonary infections due to Pseudomonas aeruginosa, including patients with ventilator-associated pneumopathies (VAP). The filing for the latter study is planned in France (ANSM) in Q1 2025.
