PHAXIAM Therapeutics announces the validation of a new investigator-initiated phase 2 study
PHAXIAM Therapeutics announces the validation of a new investigator-initiated phase 2 study called PHAGOSCARPA. The study, sponsored by Assistance Publique – Hôpitaux de Paris (AP-HP), will evaluate the efficacy of PHAXIAM's anti-S. aureus phages for treating extra-cavitary vascular graft implant infections caused by Staphylococcus aureus. The study plans to enroll 80 patients across 27 French clinical centers.
The primary endpoint is the therapeutic success rate at 3 months, including absence of clinical infection signs, normal graft function, and absence of radiological infection evidence. The study's launch is subject to validation by the French health authority (ANSM), expected in H1 2025. PHAXIAM will supply the clinical doses and negotiate access to the generated clinical data.
Two other investigator-sponsored trials are also planned: a phase 2 study in Diabetic Foot Ulcer (60 patients) and a phase 2 study in nosocomial pulmonary infections (180 patients).
PHAXIAM Therapeutics annuncia la validazione di un nuovo studio di fase 2 chiamato PHAGOSCARPA. Lo studio, sponsorizzato dall'Assistance Publique – Hôpitaux de Paris (AP-HP), valuterà l'efficacia dei fagi anti-S. aureus di PHAXIAM nel trattamento delle infezioni da impianto di innesti vascolari extracavitarie causate da Staphylococcus aureus. Lo studio prevede di arruolare 80 pazienti in 27 centri clinici francesi.
L'obiettivo primario è il tasso di successo terapeutico a 3 mesi, che include l'assenza di segni clinici di infezione, il normale funzionamento del innesto e l'assenza di evidenze radiologiche di infezione. Il lancio dello studio è soggetto a validazione da parte dell'autorità sanitaria francese (ANSM), previsto per H1 2025. PHAXIAM fornirà le dosi cliniche e negozierà l'accesso ai dati clinici generati.
Altri due studi sponsorizzati da investigatori sono anche previsti: uno studio di fase 2 per ulceri del piede diabetico (60 pazienti) e uno studio di fase 2 per infezioni polmonari nosocomiali (180 pazienti).
PHAXIAM Therapeutics anuncia la validación de un nuevo estudio iniciado por investigadores de fase 2 llamado PHAGOSCARPA. El estudio, patrocinado por Assistance Publique - Hôpitaux de Paris (AP-HP), evaluará la eficacia de los fagos anti-S. aureus de PHAXIAM para tratar infecciones de implantes de injertos vasculares extracavitarios causadas por Staphylococcus aureus. El estudio planea inscribir 80 pacientes en 27 centros clínicos franceses.
El objetivo primario es la tasa de éxito terapéutico a 3 meses, que incluye la ausencia de signos clínicos de infección, el funcionamiento normal del injerto y la ausencia de evidencia radiológica de infección. El inicio del estudio está sujeto a la validación de la autoridad sanitaria francesa (ANSM), que se espera para H1 2025. PHAXIAM proporcionará las dosis clínicas y negociará el acceso a los datos clínicos generados.
También se planean otros dos ensayos patrocinados por investigadores: un estudio de fase 2 sobre úlceras del pie diabético (60 pacientes) y un estudio de fase 2 sobre infecciones pulmonares nosocomiales (180 pacientes).
PHAXIAM Therapeutics는 PHAGOSCARPA라는 새로운 연구자 주도 2상 연구의 검증을 발표했습니다. 파리 공공병원(Ap-HP)이 후원하는 이 연구는 PHAXIAM의 항-S. aureus 파지가 황색포도상구균에 의해 발생한 비장기 혈관 이식 감염 치료의 효과를 평가합니다. 이 연구는 27개 프랑스 임상 센터에서 80명의 환자를 모집할 계획입니다.
주요 목표는 3개월 시점에서의 치료 성공률로, 이는 임상 감염 징후가 없고, 이식 기능이 정상이며, 방사선적으로 감염 증거가 없음을 포함합니다. 연구 시작은 프랑스 보건당국(ANSM)의 검증을 받아야 하며, 이는 2025년 상반기에 예상됩니다. PHAXIAM은 임상 용량을 제공하고 생성된 임상 데이터에 대한 접근을 협상합니다.
또한 두 개의 연구자 주도 시험도 계획되고 있습니다: 당뇨병성 발 궤양에 대한 2상 연구 (60명 환자)와 병원 감염성 폐 감염에 대한 2상 연구 (180명 환자).
PHAXIAM Therapeutics annonce la validation d'une nouvelle étude initiée par des chercheurs de phase 2 appelée PHAGOSCARPA. L'étude, parrainée par l'Assistance Publique – Hôpitaux de Paris (AP-HP), évaluera l'efficacité des phages anti-S. aureus de PHAXIAM pour traiter les infections d'implants de greffes vasculaires extracavitaires causées par Staphylococcus aureus. L'étude prévoit d'inclure 80 patients dans 27 centres cliniques français.
Le critère principal est le taux de succès thérapeutique à 3 mois, incluant l'absence de signes cliniques d'infection, le bon fonctionnement du greffon et l'absence de preuves radiologiques d'infection. Le lancement de l'étude est soumis à la validation par l'autorité de santé française (ANSM), prévue pour le premier semestre 2025. PHAXIAM fournira les doses cliniques et négociera l'accès aux données cliniques générées.
Deux autres essais sponsorisés par des chercheurs sont également prévus : une étude de phase 2 sur les ulcères du pied diabétique (60 patients) et une étude de phase 2 sur les infections pulmonaires nosocomiales (180 patients).
PHAXIAM Therapeutics kündigt die Validierung einer neuen, von Ermittlern initiierten Phase-2-Studie mit dem Namen PHAGOSCARPA an. Die Studie, die von Assistance Publique – Hôpitaux de Paris (AP-HP) gesponsert wird, wird die Wirksamkeit von PHAXIAMs Anti-S. aureus-Viren zur Behandlung von extrakavitär auftretenden Infektionen bei vaskulären Transplantaten, die durch Staphylococcus aureus verursacht werden, bewerten. In der Studie sollen 80 Patienten in 27 französischen Kliniken eingeschlossen werden.
Der primäre Endpunkt ist die therapeutische Erfolgsquote nach 3 Monaten, die das Fehlen klinischer Anzeichen einer Infektion, eine normale Transplantatfunktion und das Fehlen radiologischer Infektionsnachweise umfasst. Der Beginn der Studie unterliegt der Validierung durch die französische Gesundheitsbehörde (ANSM), die in H1 2025 erwartet wird. PHAXIAM wird die klinischen Dosen bereitstellen und den Zugang zu den generierten klinischen Daten verhandeln.
Es sind auch zwei weitere von Ermittlern gesponserte Studien geplant: eine Phase-2-Studie zu diabetischen Fußgeschwüren (60 Patienten) und eine Phase-2-Studie zu nosokomialen Lungeninfektionen (180 Patienten).
- Validation of a new phase 2 study (PHAGOSCARPA) for treating vascular graft infections
- Potential to address high unmet medical needs in severe and resistant bacterial infections
- Promising results from compassionate use of PHAXIAM's phage therapy
- Two additional investigator-sponsored phase 2 trials planned in high-value indications
- Study launch subject to ANSM validation, expected in H1 2025
- Long study duration of 36 months, including 24 months for patient recruitment
Insights
This news about PHAXIAM Therapeutics' new investigator-initiated phase 2 study, PHAGOSCARPA, is significant for the company's development pipeline. The study will evaluate the efficacy of PHAXIAM's anti-S. aureus phages in treating extra-cavitary vascular graft implant infections, a serious condition with high mortality rates.
Key points:
- The study targets a high unmet medical need with current mortality rates of
10-25% within 30 days and over50% after 1 year. - It will enroll 80 patients across 27 French clinical centers, demonstrating a robust study design.
- The primary endpoint is therapeutic success rate at 3 months, which includes clinical, functional and radiological criteria.
- PHAXIAM will supply the clinical doses, potentially leading to future commercialization opportunities if successful.
This study, along with two other planned investigator-sponsored trials in diabetic foot ulcers and nosocomial pulmonary infections, significantly expands PHAXIAM's clinical program. A successful outcome could position PHAXIAM as a leader in phage therapy for resistant bacterial infections, potentially opening up a substantial market opportunity.
- A Phase 2 study sponsored by Assistance Publique – Hôpitaux 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
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 – Hôpitaux 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 Nîmes 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.
For more information, please visit www.phaxiam.com
Contacts
| PHAXIAM Thibaut du Fayet CEO +33 4 78 74 44 38 investors@phaxiam.com | NewCap Mathilde Bohin / Dušan Orešanský Investor Relations Arthur Rouillé Media Relations +33 1 44 71 94 94 phaxiam@newcap.eu |
Forward-looking information
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond PHAXIAM's control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Investor should carefully read the risk factors section of the Company which can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), including in the Company’s 2023 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 5, 2024 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. PHAXIAM disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in PHAXIAM’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.
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FAQ
What is the purpose of PHAXIAM's new phase 2 study PHAGOSCARPA?
How many patients and clinical centers are involved in the PHAGOSCARPA study for PHXM?
When is the PHAGOSCARPA study for PHXM expected to begin?
What other clinical trials is PHAXIAM (PHXM) involved in?
