BiomX Announces Positive FDA Feedback Supporting Next-Generation Phage Cocktail Program for Diabetic Foot Infections
BiomX (NYSE American: PHGE) received positive FDA feedback on the clinical development pathway for BX011, a fixed multi-phage cocktail targeting Staphylococcus aureus in diabetic foot infections (DFI), and plans a Phase 2a trial in DFI subject to funding.
The FDA support includes a path toward a potential BLA, no additional non‑clinical studies expected, and CMC comments consistent with BiomX’s manufacturing strategy. BX011 uses multiple proprietary phages, including one evaluated in the prior BX211 Phase 2 DFO study, which reported statistically significant topline ulcer-size reductions. BiomX has received about $40 million in non-dilutive U.S. defense funding for its S. aureus phage program.
BiomX (NYSE American: PHGE) ha ottenuto feedback positivo dalla FDA sul percorso di sviluppo clinico per BX011, un cocktail fisso di multi-fagi che prende di mira Staphylococcus aureus nelle infezioni del piede diabetico (DFI), e pianifica uno studio di Fase 2a in DFI soggetto a finanziamento.
Il supporto della FDA comprende un percorso verso una potenziale BLA, nessun ulteriore studio non clinico previsto, e commenti CMC coerenti con la strategia di fabbricazione di BiomX. BX011 utilizza più fagi proprietari, tra cui uno valutato nel precedente studio BX211 Fase 2 DFO, che ha riportato riduzioni statisticamente significative delle dimensioni dell'ulcera. BiomX ha ricevuto circa $40 milioni di finanziamenti non diluitivi dalla difesa statunitense per il suo programma di fagi contro S. aureus.
BiomX (NYSE American: PHGE) recibió comentarios positivos de la FDA sobre la ruta de desarrollo clínico para BX011, un cóctel fijo de múltiples fagos que apunta a Staphylococcus aureus en infecciones del pie diabético (DFI), y planea un ensayo de Fase 2a en DFI sujeto a financiamiento.
El apoyo de la FDA incluye una vía hacia una potencial BLA, no se esperan estudios no clínicos adicionales y comentarios de CMC consistentes con la estrategia de fabricación de BiomX. BX011 utiliza múltiples fagos propietarios, incluido uno evaluado en el estudio previo BX211 Fase 2 DFO, que reportó reducciones de tamaño de úlcera significativamente en el topline. BiomX ha recibido aproximadamente $40 millones en financiamiento no diluyente de defensa de EE. UU. para su programa de fagos contra S. aureus.
BiomX (NYSE American: PHGE)은 당뇨병성 족부 감염(DFI)에서 Staphylococcus aureus를 표적으로 하는 고정 다파지(멀티 파지) 칵테일인 BX011의 임상 개발 경로에 대해 FDA로부터 긍정적 피드백을 받았고, 자금 조달에 따라 DFI에서 2상 2a 시험을 계획하고 있습니다.
FDA의 지원은 잠재적 BLA에 대한 경로, 추가 비임상 연구 불필요, BiomX의 제조 전략과 일치하는 CMC 코멘트를 포함합니다. BX011은 독점 파지를 다수 사용하며, 그 중 하나는 이전의 BX211 2상 DFO 연구에서 평가되었고, 궤양 크기 감소에서 통계적으로 유의한 topline을 보고했습니다. BiomX는 미국 방위부로부터 비희석(non-dilutive) 자금 약 $40 million를 받아 S. aureus 파지 프로그램을 지원하고 있습니다.
BiomX (NYSE American: PHGE) a reçu des retours positifs de la FDA sur le parcours de développement clinique pour BX011, un cocktail fixe multi-phages ciblant Staphylococcus aureus dans les infections du pied diabétique (DFI), et prévoit un essai de Phase 2a en DFI sous réserve de financement.
Le soutien de la FDA comprend une voie vers une éventuelle BLA, pas d'études non cliniques supplémentaires prévues et des commentaires CMC conformes à la stratégie de fabrication de BiomX. BX011 utilise plusieurs phages propriétaires, dont l'un évalué dans l'étude précédente BX211 Phase 2 DFO, qui a rapporté des réductions de taille d'ulcère statistiquement significatives. BiomX a reçu environ $40 millions de financement non dilutif du ministère américain de la Défense pour son programme de phages contre S. aureus.
BiomX (NYSE American: PHGE) erhielt positives Feedback der FDA zum klinischen Entwicklungsweg für BX011, ein festes Multi-Phagen-Cocktail, das Staphylococcus aureus bei diabetischen Fußinfektionen (DFI) angreift, und plant eine Phase 2a-Untersuchung in DFI, sofern Finanzierung vorhanden ist.
Die FDA-Unterstützung umfasst einen Weg zu einer potenziellen BLA, keine weiteren nicht-klinischen Studien erwartet und CMC-Kommentare, die mit BiomX' Fertigungsstrategie übereinstimmen. BX011 verwendet mehrere eigentumsrechte Phagen, darunter eines, das in der vorherigen BX211 Phase-2-DFO-Studie bewertet wurde, welche statistisch signifikante topline Wundgrößenreduzierungen berichtete. BiomX hat ungefähr $40 Millionen an nicht dilutive US-Verteidigungsfinanzierungen für sein S. aureus-Phagen-Programm erhalten.
BiomX (NYSE American: PHGE) تلقّت تعليقات FDA إيجابية على مسار التطوير السريري لـ BX011، وهو مزيج ثابت متعدد الفاجات يستهدف Staphylococcus aureus في عدوى القدم السكريّة (DFI)، وتخطط لتجربة المرحلة 2 أ في DFI رهناً بالتمويل.
تشمل دعم FDA مساراً نحو احتمال BLA، لا يُتوقع وجود دراسات غير سريرية إضافية، وتعليقات CMC تتسق مع استراتيجية التصنيع لدى BiomX. BX011 يستخدم عدة فاجات مملوكة، بما في ذلك واحد تم تقييمه في الدراسة السابقة BX211 المرحلة 2 DFO، التي أبلغت عن انخفاضات ذات دلالة إحصائية في حجم القرحة بشكل رئيسي. تلقت BiomX حوالى $40 مليون من تمويل دفاعي غير مخفف للولايات المتحدة لبرنامجها للفاجات ضد S. aureus.
- FDA feedback supports a path toward a BLA
- $40 million in non-dilutive U.S. defense funding secured
- BX011 includes phage previously tested in BX211
- BX211 Phase 2 showed statistically significant ulcer-size reductions
- No additional non-clinical studies are expected per FDA
- Advancement of BX011 is subject to availability of necessary financial resources
Insights
FDA supports a clear clinical and regulatory path for BX011 in diabetic foot infections; Phase 2a planned.
BiomX has received FDA feedback that aligns the proposed development of BX011 for diabetic foot infections (DFI) with existing regulatory guidance and a potential BLA pathway, while noting no additional non‑clinical studies are expected and CMC comments match the company’s current manufacturing plan. The FDA confirmation of a clinical pathway reduces a key regulatory unknown and preserves the option to leverage previously evaluated phages included in this multi‑phage cocktail.
Material dependencies and risks remain defined in the disclosure: initiation of a Phase 2a trial depends on the availability of necessary financial resources and continued alignment with the U.S. Defense Health Agency (DHA). The program also relies on prior clinical signals from BX211, which the company reported as statistically significant in
Watch for three monitorable items over the next 6–18 months: progress securing funding or DHA alignment, formal trial initiation documents for the planned Phase 2a, and any FDA meeting minutes or written concurrence that would confirm the absence of required non‑clinical studies. These items will materially affect the program’s timeline toward regulatory submission.
New FDA feedback confirms clinical pathway for fixed multi-phage cocktail BX011, expanding development into diabetic foot infections (DFI) and unlocking a major commercial opportunity
NESS ZIONA, Israel, Nov. 04, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed clinical developmental pathway for BX011, a next-generation fixed multi-phage cocktail targeting Staphylococcus aureus (S. aureus) in diabetic foot infections (DFI).
FDA feedback supports BiomX’s plan to advance its phage-based therapy into DFI as the next clinical indication, following the Company’s previous Phase 2 study of BX211, a phage product for the treatment of diabetic foot osteomyelitis (DFO) caused by S. aureus. The decision to focus on DFI reflects three key factors: a broader patient population with a significant unmet medical need, a large commercial opportunity, and a clear regulatory path supported by established FDA guidance. The two indications share the same S. aureus pathogen, making DFI the appropriate initial indication for regulatory approval prior to potential development in DFO.
The new formulation, BX011, includes multiple proprietary phages, among them phage previously evaluated in the BX211 study. BiomX’s development of phage therapies for S. aureus has been supported by approximately
The FDA provided detailed guidance supporting a path toward a potential Biologics License Application (BLA). No additional non-clinical studies are expected, and the FDA’s comments on Chemistry, Manufacturing, and Controls (CMC) are consistent with BiomX’s existing manufacturing and quality strategy. The feedback confirms that the BX011 development plan is in accordance with current FDA guidance for DFI product development.
“By targeting what is usually an earlier stage of disease, where infection remains in the ulcer rather than progressing to the bone, we aim to reach a broader patient population and maximize both the commercial and therapeutic impact of our program” said Jonathan Solomon, Chief Executive Officer of BiomX. “The FDA’s comments reinforce our goal of bringing phage therapy into mainstream infectious disease care.”
In March 2025, BiomX reported statistically significant positive topline results from its Phase 2 BX211 trial targeting S. aureus in DFO. BX211 was safe and well tolerated, achieving significant and sustained reductions in ulcer size, with a clear separation from placebo starting at week 7, and improvements in ulcer depth observed at week 13. All patients received standard of care, including systemic antibiotic therapy, throughout the 12-week treatment period.
About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.
Safe Harbor
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX refers to the potential benefits of BX011, the next steps in development of BX011, the potential of this product candidate, including BLA, any need for additional non-clinical studies or other actions before clinical trial (if such trials are initiated at all), future compliance of the development of BX011 with FDA guidance, discussions with the DHA and sufficiency of financing resources, it is using forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX’s control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA, and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
Contacts:
BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com
FAQ
What did the FDA tell BiomX about BX011 on November 4, 2025?
How does BX011 relate to BiomX’s prior BX211 Phase 2 results for PHGE?
When does BiomX plan to start a Phase 2a trial in DFI for PHGE?
How much non-dilutive funding has supported BiomX’s S. aureus phage development?
Does the FDA require additional preclinical studies for BX011?
