PHAXIAM Therapeutics Receives FDA Clearance to Initiate Phase II GLORIA Study in the U.S.
PHAXIAM Therapeutics has received FDA IND clearance for GLORIA, the world's first Phase II phage therapy study in Prosthetic Joint Infections (PJI) caused by Staphylococcus aureus. The multicenter, randomized, placebo-controlled study will include 100 patients across the US and Europe, with recruitment starting Q1 2025 and data readout expected Q3 2026. The study targets PJI, affecting 50-60,000 new cases yearly in Western countries, with current treatments showing 50% failure rates. The US market for anti-S. aureus phages in PJI is estimated at €600-700 million. Upon successful completion, PHAXIAM could seek Conditional Market Approval for European pre-commercialization by second half of 2027.
PHAXIAM Therapeutics ha ricevuto l'approvazione IND dalla FDA per GLORIA, il primo studio di fase II al mondo riguardante la terapia a base di fagi per le Infezioni da Giunto Protesico (PJI) causate da Staphylococcus aureus. Lo studio multicentrico, randomizzato e controllato con placebo includerà 100 pazienti negli Stati Uniti e in Europa, con avvio del reclutamento previsto per il primo trimestre del 2025 e lettura dei dati attesa per il terzo trimestre del 2026. Lo studio si concentra sulle PJI, che colpiscono 50-60.000 nuovi casi all'anno nei paesi occidentali, con i trattamenti attuali che mostrano tassi di fallimento del 50%. Il mercato statunitense per i fagi anti-S. aureus nelle PJI è stimato tra i 600 e i 700 milioni di euro. Una volta completato con successo, PHAXIAM potrebbe richiedere l'Autorizzazione Condizionata alla Commercializzazione per la pre-commercializzazione europea entro la seconda metà del 2027.
PHAXIAM Therapeutics ha recibido la autorización IND de la FDA para GLORIA, el primer estudio de fase II en el mundo sobre la terapia de fagos para Infecciones de Articulaciones Protésicas (PJI) causadas por Staphylococcus aureus. El estudio multicéntrico, aleatorizado y controlado con placebo incluirá a 100 pacientes en EE. UU. y Europa, con el reclutamiento comenzando en el primer trimestre de 2025 y la lectura de datos esperada para el tercer trimestre de 2026. El estudio se centra en las PJI, que afectan a 50-60,000 nuevos casos anuales en países occidentales, con tratamientos actuales que muestran tasas de fracaso del 50%. El mercado estadounidense para fagos anti-S. aureus en PJI se estima en 600-700 millones de euros. Tras la finalización exitosa, PHAXIAM podría solicitar la Aprobación Condicionada de Mercado para la pre-comercialización europea a mediados de 2027.
PHAXIAM Therapeutics는 Staphylococcus aureus로 인한 인공관절 감염(PJI)에 대한 세계 최초의 2상 파지 치료 연구인 GLORIA에 대해 FDA의 IND 승인을 받았습니다. 이 다기관, 무작위 배정, 위약 대조 연구에는 미국과 유럽에서 100명의 환자가 포함될 예정이며, 2025년 1분기에 모집이 시작되고 2026년 3분기에 데이터 결과가 예상됩니다. 이 연구는 매년 서구 국가에서 50,000-60,000건의 새로운 사례에 영향을 미치는 PJI에 초점을 맞추고 있으며, 현재 치료법의 실패율은 50%에 달합니다. PJI에서 항 S. aureus 파지에 대한 미국 시장은 약 6억-7억 유로로 추정됩니다. 성공적으로 완료되면, PHAXIAM은 2027년 하반기에 유럽의 사전 상용화를 위한 조건부 시장 승인을 요청할 수 있습니다.
PHAXIAM Therapeutics a reçu l'autorisation IND de la FDA pour GLORIA, la première étude de phase II au monde sur la thérapie par phages pour les Infections de Prothèses Articulaires (PJI) causées par Staphylococcus aureus. L'étude multicentrique, randomisée et contrôlée par placebo inclura 100 patients aux États-Unis et en Europe, avec un début de recrutement prévu pour le premier trimestre de 2025 et une analyse des données attendue au troisième trimestre de 2026. L'étude cible les PJI, qui touchent 50 à 60 000 nouveaux cas par an dans les pays occidentaux, les traitements actuels affichant des taux d'échec de 50 %. Le marché américain pour les phages anti-S. aureus dans les PJI est estimé entre 600 et 700 millions d'euros. À l'issue d'un succès, PHAXIAM pourrait demander une Autorisation de Mise sur le Marché Conditionnelle pour la pré-commercialisation européenne d'ici la deuxième moitié de 2027.
PHAXIAM Therapeutics hat die FDA IND-Genehmigung für GLORIA erhalten, die weltweit erste Phase-II-Phagentherapiestudie bei Prothesengelenkinfektionen (PJI) verursacht durch Staphylococcus aureus. Die multizentrische, randomisierte, placebo-kontrollierte Studie wird 100 Patienten in den USA und Europa einschließen, wobei die Rekrutierung im ersten Quartal 2025 beginnen und die Datenauswertung im dritten Quartal 2026 erwartet wird. Die Studie zielt auf PJI ab, die jährlich 50.000 bis 60.000 neue Fälle in westlichen Ländern betreffen, wobei die derzeitigen Behandlungen einer 50%igen Fehlerrate aufweisen. Der US-Markt für Anti-S. aureus-Phägen in PJI wird auf 600 bis 700 Millionen Euro geschätzt. Nach erfolgreichem Abschluss könnte PHAXIAM eine bedingte Marktzulassung für die europäische Vorab-Kommerzialisierung in der zweiten Hälfte von 2027 anstreben.
- FDA IND clearance received for Phase II GLORIA study
- First worldwide multicenter randomized controlled trial in phage therapy for PJI
- Large market opportunity with €600-700 million potential in US market alone
- Existing positive clinical data from compassionate use cases
- Potential for early market access and Conditional Market Approval by H2 2027
- Study recruitment not starting until Q1 2025
- Long timeline to potential commercialization (2027+)
- European regulatory approvals still pending
Insights
The FDA's IND clearance for PHAXIAM's GLORIA Phase II study marks a significant milestone in addressing Prosthetic Joint Infections. The study targets a $650-750 million US market for S. aureus phage therapy, with current treatments showing concerning failure rates of
The trial design is particularly robust, involving 100 patients across multiple centers in the US and Europe. The company's existing compassionate use data showing positive safety and clinical benefits strengthens the probability of trial success. If successful, European commercialization could begin as early as H2 2027 through Conditional Market Approval.
Key market factors include:
- 50-60,000 new PJI cases annually in Western countries
- Current treatments show
60% reinfection rate - US incidence is 3x higher than Europe with
25-30% higher pricing
This development positions PHAXIAM as a potential leader in the underserved PJI treatment market. The global, multi-center approach spanning 8 countries significantly enhances the study's credibility and commercial potential. The combination of high unmet need, substantial market size and favorable pricing dynamics in the US market creates a compelling commercial opportunity.
The
- GLORIA, the world's 1st phase II phage therapy study in the treatment of Prosthetic Joint Infections (PJI) related to Staphylococcus aureus
- The clinical protocol also being submitted to the European health authorities and the MHRA in the UK
- Patients recruitment scheduled to start in Q1 2025 for clinical data readout expected in Q3 2026
Lyon (France), November 04, 2024 – 6:00 pm CET - PHAXIAM Therapeutics (Euronext: PHXM - FR0011471135), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, announces that it has received Investigational New Drug approval (IND) for its Phase II study, GLORIA, in Prosthetic Joint Infections (PJI) caused by Staphylococcus aureus (S. aureus).
The GLORIA study is PHAXIAM's most strategic asset, with the highest priority. This study will be the 1st worldwide (Europe and United States) multicenter, randomized, placebo-controlled, proof-of-concept study in phage therapy and in PJI. The study plans to include 100 patients with PJI (hip or knee replacement) with open surgical debridement (DAIR), who will be treated with PHAXIAM's anti-S. aureus phages or placebo, in combination with antibiotics.
Prosthetic Joint Infection (PJI) is a severe complication that affects thousands of patients who have received hip or knee replacements, with 50-60,000 new cases per year in Western countries1. The unmet medical need is considerable insofar as current standards of care show a failure rate of
Phage therapy represents a promising solution in this context and PHAXIAM benefits from a leadership position in this indication. This status is supported by robust clinical data from several dozen patients treated in real-life compassionate setting with locally administered anti-S. aureus phages, which confers to the treatment a very good safety profile and already showed clinical benefits.
The IND approval received from the FDA on the GLORIA study protocol is a major step forward in the deployment of PHAXIAM's international clinical strategy. The company has already identified 5 clinical centers and intends to reach 10 participating centers to ensure a territorial network coverage to optimize the recruitment of the study.
Based on the structuring exchanges with the FDA, PHAXIAM is also about to finalize the filing of the clinical protocol with the main European health authorities3, including the British MHRA. Subject to these approvals, the GLORIA study will be conducted in 7 European countries (France, Germany, UK, Spain, Italy, Netherlands, Sweden) and the United States, making it the most robust phage therapy study in the world.
Professor Tristan Ferry, coordinator of the Reference Center for Complex Osteoarticular Infections (CRIOAC) at the Croix-Rousse Hospital (HCL, Lyon) and internationally recognized expert in phage therapy, will be the principal investigator of the study.
Subject to the successful completion of GLORIA, expected in Q3 2026, PHAXIAM could be eligible for an early access process and could look for getting Conditional Market Approval (CMA), paving the way for pre-commercialization in Europe as early as the second half of 2027.
Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics, said: "This FDA IND clearance is a major recognition of our therapeutic approach and of our whole platform. This is a key milestone in our most strategic S. aureus program, and I would like to thank all our teams who have contributed to it. This is the first time that PHAXIAM will be in a position to conduct clinical development in the United States, and we look forward to moving ahead in the collaboration with the participating centers already identified. In parallel, we are finalizing the submission of the GLORIA protocol to the European authorities, with the aim of obtaining authorizations in seven countries of the European Union and the United Kingdom in the coming weeks. The confirmed objective remains to be able to start the recruitment of this first global study in phage therapy during the 1st quarter of 2025, as initially planned. With these strategic advances, we are about to reinforce our position as a leader in phage therapy for Prosthetic Joint Infection, a critical indication with high worldwide incidence and critical unmet medical needs. The GLORIA study may be the first global study to deliver a robust (with 100 patients enrolled) clinical proof-of-concept for phages. We consider that relying on the large PJI compassionate clinical data package, already generated in real life, the likelihood of success of this trial is rather high. We remain determined to provide a major solution and hope to many patients in a therapeutic impasse.”
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.
1 Europe 27 and the United States
2 Source: internal evaluation by the Company
3 A CTA (Clinical Trial Approval) application will be filed to be able to conduct the study in the 5 main European countries (France, Germany, Italy, Spain and the United Kingdom), as well as in Sweden and the Netherlands.
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FAQ
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