BiomX Announces Publication in Nature Communications of Phage Cocktail BX004 Phase 1b/2a Part 1 Data Demonstrating Strong Activity in Cystic Fibrosis
BiomX (NYSE American: PHGE) has published Phase 1b/2a Part 1 trial results of its phage cocktail BX004 in Nature Communications, demonstrating significant efficacy against antibiotic-resistant P. aeruginosa infections in cystic fibrosis patients.
The study revealed a remarkable 500-fold (2.7 log₁₀) bacterial reduction compared to placebo, with no emerging resistance. Key findings include a strong safety profile, successful bacterial reduction achieved at day 15, and therapeutic phages reaching and persisting at infection sites. The treatment demonstrated favorable microbiome composition shifts and maintained efficacy where traditional antibiotics often fail.
BiomX is currently advancing its Phase 2b trial of BX004, with topline results expected in Q1 2026.
BiomX (NYSE American: PHGE) ha pubblicato i risultati della fase 1b/2a Parte 1 dello studio sul suo cocktail di fagi BX004 su Nature Communications, dimostrando un'efficacia significativa contro le infezioni da P. aeruginosa resistenti agli antibiotici nei pazienti con fibrosi cistica.
Lo studio ha evidenziato una straordinaria riduzione batterica di 500 volte (2,7 log₁₀) rispetto al placebo, senza emergere resistenze. I risultati principali includono un profilo di sicurezza solido, una riduzione batterica efficace già al giorno 15 e la capacità dei fagi terapeutici di raggiungere e persistere nei siti di infezione. Il trattamento ha mostrato cambiamenti favorevoli nella composizione del microbioma e ha mantenuto efficacia dove gli antibiotici tradizionali spesso falliscono.
BiomX sta attualmente portando avanti la fase 2b dello studio su BX004, con risultati preliminari attesi nel primo trimestre 2026.
BiomX (NYSE American: PHGE) ha publicado los resultados de la fase 1b/2a Parte 1 de su ensayo con el cóctel de fagos BX004 en Nature Communications, demostrando una eficacia significativa contra infecciones de P. aeruginosa resistentes a antibióticos en pacientes con fibrosis quística.
El estudio reveló una notable reducción bacteriana de 500 veces (2,7 log₁₀) en comparación con el placebo, sin aparición de resistencia. Los hallazgos clave incluyen un perfil de seguridad sólido, reducción bacteriana lograda al día 15 y fagos terapéuticos que alcanzan y persisten en los sitios de infección. El tratamiento mostró cambios favorables en la composición del microbioma y mantuvo eficacia donde los antibióticos tradicionales a menudo fallan.
BiomX está actualmente avanzando en su ensayo de fase 2b de BX004, con resultados preliminares esperados en el primer trimestre de 2026.
BiomX (NYSE American: PHGE)는 Nature Communications에 파지 칵테일 BX004의 1b/2a 1부 임상시험 결과를 발표하며 낭포성 섬유증 환자의 항생제 내성 P. aeruginosa 감염에 대해 유의미한 효능을 입증했습니다.
연구에서는 위약 대비 500배(2.7 log₁₀) 박테리아 감소를 보여주었고, 내성 발생은 없었습니다. 주요 결과로는 강력한 안전성 프로필, 15일째에 달성된 박테리아 감소, 치료용 파지가 감염 부위에 도달해 지속됨이 포함됩니다. 치료는 미생물군집 구성의 긍정적 변화를 보였고, 기존 항생제가 실패하는 곳에서도 효능을 유지했습니다.
BiomX는 현재 BX004의 2b상 임상시험을 진행 중이며, 2026년 1분기에 주요 결과가 발표될 예정입니다.
BiomX (NYSE American : PHGE) a publié les résultats de la phase 1b/2a partie 1 de son essai sur le cocktail de phages BX004 dans Nature Communications, démontrant une efficacité significative contre les infections à P. aeruginosa résistantes aux antibiotiques chez les patients atteints de mucoviscidose.
L'étude a révélé une réduction bactérienne remarquable de 500 fois (2,7 log₁₀) par rapport au placebo, sans apparition de résistances. Les principales conclusions incluent un profil de sécurité solide, une réduction bactérienne obtenue dès le jour 15, et des phages thérapeutiques atteignant et persistant sur les sites d'infection. Le traitement a montré des modifications favorables de la composition du microbiome et a maintenu son efficacité là où les antibiotiques traditionnels échouent souvent.
BiomX poursuit actuellement son essai de phase 2b de BX004, avec des résultats principaux attendus au premier trimestre 2026.
BiomX (NYSE American: PHGE) hat die Ergebnisse der Phase 1b/2a Teil 1 Studie seines Phagen-Cocktails BX004 in Nature Communications veröffentlicht und dabei eine signifikante Wirksamkeit gegen antibiotikaresistente P. aeruginosa-Infektionen bei Mukoviszidose-Patienten nachgewiesen.
Die Studie zeigte eine bemerkenswerte 500-fache (2,7 log₁₀) bakterielle Reduktion im Vergleich zum Placebo, ohne dass Resistenzen auftraten. Wichtige Erkenntnisse umfassen ein starkes Sicherheitsprofil, eine erfolgreiche bakterielle Reduktion bereits am Tag 15 und das Erreichen sowie Verbleiben therapeutischer Phagen an den Infektionsstellen. Die Behandlung führte zu günstigen Veränderungen der Mikrobiom-Zusammensetzung und behielt ihre Wirksamkeit dort, wo herkömmliche Antibiotika oft versagen.
BiomX führt derzeit seine Phase 2b Studie zu BX004 durch, mit Topline-Ergebnissen, die im 1. Quartal 2026 erwartet werden.
- Achieved significant 500-fold (2.7 log₁₀) bacterial reduction compared to placebo
- Strong safety profile with no treatment-related safety events
- No bacterial resistance emerged during treatment
- Publication in prestigious Nature Communications validates the therapy platform
- Phase 2b trial advancement shows continued development progress
- Phase 2b results not expected until Q1 2026
- Small sample size in Phase 1b/2a Part 1 study (only 9 patients)
Insights
BiomX's phage therapy shows 500-fold bacterial reduction in CF patients where antibiotics failed, with Phase 2b results expected Q1 2026.
BiomX's publication in Nature Communications represents a significant milestone for phage therapy development. The data demonstrates that their BX004 phage cocktail achieved a remarkable
Three aspects of this data are especially promising: First, no bacterial resistance emerged during treatment, addressing a critical limitation of conventional antibiotics. Second, the phages persisted at the infection site up to a week after treatment ended, suggesting potential for less frequent dosing. Third, treatment led to favorable shifts in microbiome composition, increasing overall diversity while specifically targeting the pathogenic bacteria.
The methodology behind BX004's development is equally impressive - environmental phages were isolated and screened against P. aeruginosa grown in conditions mimicking the CF lung environment, and computational screening confirmed absence of antibiotic resistance or virulence genes. This translational path from discovery to clinical testing demonstrates a rigorous scientific approach to phage therapy development.
With Phase 2b already underway and results expected Q1 2026, BiomX is at the forefront of bringing phage therapy into mainstream medicine for respiratory infections that have substantial unmet needs. The publication in such a prestigious journal provides crucial validation for their platform and approach to treating antibiotic-resistant infections.
Premier research journal article provides validation for BiomX’s phage therapy platform, showcasing first-in-human Phase 1b/2a trial results for antibiotic-resistant P. aeruginosa infections
New, updated data demonstrates a further bacteria reduction of 2.7 log₁₀ (approximately 500-fold) compared to placebo, with no emergent resistance and preservation of a healthy microbiome
BiomX is advancing its Phase 2b trial of BX004 with topline results expected Q1 2026
NESS ZIONA, Israel, July 08, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the publication of a peer-reviewed article in Nature Communications titled, “Phage therapy with nebulized cocktail BX004-A for chronic Pseudomonas aeruginosa infections in cystic fibrosis: a randomized first-in-human trial”. The article notably features previously unreported antimicrobial efficacy data from the Phase 1b/2a clinical trial and reinforces the strength of BiomX's innovative approach to developing bacteriophage therapies for chronic disease with substantial unmet needs. The publication is available at: Link.
“The publication of our peer-reviewed results in a preeminent research journal, including new data showing antimicrobial activity of BX004, provides significant third-party validation of our phage therapy platform to treat patients with chronic P. aeruginosa cystic fibrosis (CF) infections,” said Jonathan Solomon, BiomX's Chief Executive Officer. “Building upon the strong scientific rigor of our clinical program and our findings in patients showing meaningful bacterial reduction where antibiotics have failed, we have initiated our Phase 2b trial of BX004, with topline results expected in the first quarter of 2026.”
The peer-reviewed results of Part 1 of BiomX’s BX004 Phase 1b/2a study include new analyses showing that BX004 achieved a substantially greater improvement of approximately 500-fold (additional improvement of 2.7 log₁₀) in bacterial reduction compared with placebo in CF patients. Notably, the data highlights that no bacterial resistance to BX004 emerged during the trial, addressing a critical limitation of traditional antibiotics. Findings from Part 1 of the Phase 1b/2a study were consistent with the results observed in Part 2.
“Drawing on decades of experience in large-scale genomic analysis and bacterial defense mechanisms, the study demonstrates how large-scale data analysis can be used to optimize bacteriophage cocktails for treating chronic infection associated with cystic fibrosis,” said Rotem Sorek, Ph.D., Professor of Genetics, Weizmann Institute of Science. “By combining experimental and computational methods, we've developed a design approach that broadens bacterial strain coverage, lowers the likelihood of resistance, and enhances activity against bacterial biofilms, establishing an effective framework for designing next-generation bacteriophage therapeutics.”
Key Highlights from the Study
Part 1 of BiomX's Phase 1b/2a study evaluated the safety, tolerability, pharmacokinetics, and anti-microbiologic activity of BX004 over a 7-day treatment period in nine CF patients (seven on BX004, two on placebo) with chronic P. aeruginosa pulmonary infection. The Part 1 data demonstrated:
- Strong Safety Profile: BX004 was safe and well-tolerated with no treatment-related safety events across all patients and dose levels tested.
- Successful bacterial reduction achieved: At day 15, BX004-treated patients showed a negative 1.42 log₁₀ reduction in P. aeruginosa bacteria from baseline, while patients receiving placebo worsened by +1.26 log₁₀ CFU/g. This 2.7 log₁₀ CFU/g treatment effect (which represents approximately a 500-fold, or
99.8% 1, greater bacterial reduction with BX004 versus placebo) was achieved on top of standard of care inhaled antibiotics. These findings resulted from an additional post hoc analysis and are being reported for the first time. Results at day 4 during BX004 treatment showed P. aeruginosa burden reduction (1.9 log₁₀ CFU per gram of sputum difference between groups). - Therapeutic phages successfully reached and persisted at infection site: Phages were detected in all patients treated with BX004 during the dosing period, including in several patients up to day 15 (one week after end of therapy). As expected, no phages were detected in patients receiving placebo.
- No bacterial resistance to treatment: There was no emerging treatment-related resistance to BX004 during or after treatment with BX004, addressing efficacy of phage against bacteria where resistance is common amongst traditional antibiotics.
- Favorable shifts in microbiome composition post treatment: Microbiological signals included a reduction in P. aeruginosa relative abundance and an increase in microbiome alpha diversity in the phage-treated group, in contrast to the placebo group.
The Nature Communications publication describes the full translational path from laboratory discovery to clinical testing. Environmental phages were isolated and screened using P. aeruginosa grown under conditions mimicking the CF lung environment. In silico screening confirmed the absence of known genes associated with antibiotic resistance or virulence.
About BX004
BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In February 2023, BiomX announced positive results from Part 1 of the Phase 1b/2a study, showing safety, tolerability, and microbiologic activity. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial, in which BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<
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 its plans to initiate and enroll patients in the Phase 2b trial and timing of topline results thereof, enrollment of patients in a Phase 2b trial of BX004, the Company’s leadership in developing natural and engineered phage cocktails and personalized phage treatments for chronic diseases, the potential safety, efficacy and toleration of BX004, the potential benefits of BX004, future clinical development of BX004, and the potential of its candidates to address the substantial unmet needs of patients with intractable infections, 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
1 A 2.7 log₁₀ reduction represents a 10^2.7 = ~500-fold reduction in bacterial load, which equates to approximately
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