BiomX Announces Successful Initiation of Phase 2b Trial with First Patient Dosed in BX004 Program in Patients with Cystic Fibrosis
BiomX (NYSE American: PHGE) has initiated patient dosing in its Phase 2b trial of BX004, a phage therapy targeting antibiotic-resistant Pseudomonas aeruginosa infections in cystic fibrosis patients. The randomized, double-blind, placebo-controlled study will evaluate approximately 60 patients over an 8-week treatment period.
The trial follows promising Phase 1b/2a results where 14.3% of patients achieved complete bacterial clearance after just 10 days of treatment. The company expects topline results in Q1 2026 and anticipates FDA feedback in H2 2025 regarding the use of real-world evidence linking bacterial reduction to clinical outcomes. BX004 has already received Fast Track and Orphan Drug designations.
BiomX (NYSE American: PHGE) ha iniziato la somministrazione ai pazienti nella sua sperimentazione di Fase 2b di BX004, una terapia a base di fagi mirata alle infezioni da Pseudomonas aeruginosa resistenti agli antibiotici nei pazienti con fibrosi cistica. Lo studio, randomizzato, in doppio cieco e controllato con placebo, valuterà circa 60 pazienti durante un periodo di trattamento di 8 settimane.
La sperimentazione segue risultati promettenti della Fase 1b/2a in cui il 14,3% dei pazienti ha raggiunto una completa eliminazione batterica dopo soli 10 giorni di trattamento. L'azienda prevede risultati principali nel primo trimestre del 2026 e si aspetta un riscontro dalla FDA nella seconda metà del 2025 riguardo all'uso di evidenze real-world che collegano la riduzione batterica agli esiti clinici. BX004 ha già ottenuto le designazioni Fast Track e Orphan Drug.
BiomX (NYSE American: PHGE) ha iniciado la dosificación de pacientes en su ensayo de Fase 2b con BX004, una terapia con fagos dirigida a infecciones por Pseudomonas aeruginosa resistentes a antibióticos en pacientes con fibrosis quística. El estudio aleatorizado, doble ciego y controlado con placebo evaluará aproximadamente a 60 pacientes durante un periodo de tratamiento de 8 semanas.
El ensayo sigue resultados prometedores de la Fase 1b/2a donde el 14.3% de los pacientes logró una eliminación bacteriana completa tras solo 10 días de tratamiento. La compañía espera resultados principales en el primer trimestre de 2026 y anticipa retroalimentación de la FDA en la segunda mitad de 2025 sobre el uso de evidencia del mundo real que vincula la reducción bacteriana con resultados clínicos. BX004 ya ha recibido las designaciones Fast Track y Orphan Drug.
BiomX (NYSE American: PHGE)는 낭포성 섬유증 환자의 항생제 내성 Pseudomonas aeruginosa 감염을 표적으로 하는 파지 치료제 BX004의 2b상 임상시험에서 환자 투약을 시작했습니다. 무작위 배정, 이중 맹검, 위약 대조 연구로 약 60명 환자를 대상으로 8주간 치료를 평가할 예정입니다.
이번 임상은 1b/2a상에서 환자의 14.3%가 단 10일 치료 후 완전한 세균 제거를 달성한 유망한 결과를 바탕으로 진행됩니다. 회사는 2026년 1분기 주요 결과를 기대하며, 2025년 하반기에 FDA로부터 세균 감소와 임상 결과 연계를 위한 실제 데이터 사용에 대한 피드백을 받을 것으로 예상합니다. BX004는 이미 신속 심사(Fast Track) 및 희귀 의약품 지정(Orphan Drug)을 받았습니다.
BiomX (NYSE American : PHGE) a commencé la dose aux patients dans son essai de phase 2b de BX004, une thérapie par phages ciblant les infections à Pseudomonas aeruginosa résistantes aux antibiotiques chez les patients atteints de fibrose kystique. L'étude randomisée, en double aveugle et contrôlée par placebo, évaluera environ 60 patients sur une période de traitement de 8 semaines.
L'essai fait suite à des résultats prometteurs de la phase 1b/2a où 14,3 % des patients ont obtenu une élimination complète des bactéries après seulement 10 jours de traitement. La société prévoit des résultats principaux au premier trimestre 2026 et anticipe un retour de la FDA au second semestre 2025 concernant l'utilisation de preuves du monde réel liant la réduction bactérienne aux résultats cliniques. BX004 a déjà reçu les statuts Fast Track et médicament orphelin.
BiomX (NYSE American: PHGE) hat mit der Dosierung von Patienten in seiner Phase-2b-Studie zu BX004 begonnen, einer Phagentherapie, die auf antibiotikaresistente Pseudomonas aeruginosa-Infektionen bei Mukoviszidose-Patienten abzielt. Die randomisierte, doppelblinde, placebokontrollierte Studie wird etwa 60 Patienten über einen Behandlungszeitraum von 8 Wochen untersuchen.
Die Studie folgt auf vielversprechende Ergebnisse der Phase 1b/2a, bei der 14,3 % der Patienten nach nur 10 Tagen Behandlung eine vollständige bakterielle Eliminierung erreichten. Das Unternehmen erwartet Topline-Ergebnisse im ersten Quartal 2026 und rechnet mit Feedback der FDA in der zweiten Hälfte 2025 bezüglich der Nutzung von Real-World-Daten, die die bakterielle Reduktion mit klinischen Ergebnissen verknüpfen. BX004 hat bereits Fast Track- und Orphan-Drug-Designationen erhalten.
- Successful Phase 1b/2a results showed 14.3% complete bacterial clearance in patients after 10 days
- FDA Fast Track and Orphan Drug designations already secured
- Potential streamlined approval pathway if FDA agrees to microbiological endpoint
- Strong patient and investigator enthusiasm based on early results
- Final trial results not expected until Q1 2026
- FDA feedback on approval pathway still pending
- Relatively small trial size of 60 patients
Insights
BiomX's Phase 2b trial initiation for phage therapy BX004 represents significant progress toward addressing deadly antibiotic-resistant CF infections.
BiomX has successfully dosed its first patient in the Phase 2b trial for BX004, a phage therapy targeting Pseudomonas aeruginosa infections in cystic fibrosis patients. This milestone builds on promising Phase 1b/2a results where
The randomized, double-blind, placebo-controlled Phase 2b study will evaluate approximately 60 CF patients, randomized 2:1 to receive either BX004 or placebo via inhalation twice daily for 8 weeks. The trial's multiple efficacy endpoints include bacterial burden reduction, lung function improvements, and quality-of-life measures.
What makes this particularly significant is that P. aeruginosa remains a leading cause of death in CF patients despite modern treatments. The potential regulatory pathway is noteworthy – BiomX expects FDA feedback in H2 2025 regarding plans to link bacterial reduction to clinical outcomes through real-world evidence. If successful, this could streamline the approval process, leveraging the program's existing Fast Track and Orphan Drug designations.
Topline results expected in Q1 2026 will be crucial. If positive, BX004 could become the leading phage-based therapy for these deadly antibiotic-resistant infections – addressing a critical unmet need in a vulnerable patient population where current treatments often fail.
First patient dosing in Company’s Phase 2b trial marks pivotal milestone in phage therapy development program targeting antibiotic-resistant lung infections in Cystic Fibrosis patients; topline results are expected in Q1 2026
Prior Phase 1b/2a efficacy findings demonstrated complete bacterial clearance in
Feedback from U.S. Food and Drug Administration (FDA) anticipated in H2 2025, regarding plans to evaluate investigation and use of real-world evidence linking bacterial reduction to clinical outcomes; successful alignment could potentially streamline approval pathway for this urgently needed treatment option
NESS ZIONA, Israel, July 14, 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 successful initiation of patient dosing in the Company’s Phase 2b trial with first patient dosed. The trial is evaluating BX004 for the treatment of cystic fibrosis (CF) patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) infections, which remain a leading cause of death in this patient population despite modern treatments. Pending topline results expected in the first quarter of 2026, BX004 could potentially be positioned as the leading phage-based therapy for CF patients with these deadly infections.
“This first patient dosing marks a significant milestone for our BX004 program and for CF patients with chronic P. aeruginosa infections who desperately need new options,” said Jonathan Solomon, Chief Executive Officer of BiomX. “We're seeing tremendous enthusiasm from both patients and investigators based on our encouraging Phase 1b/2a results, in which
The Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating BX004 in approximately 60 CF patients with chronic P. aeruginosa infections. Patients are randomized 2:1 to receive either BX004 or placebo via inhalation twice daily for 8 weeks. The trial is designed to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function1, and enhanced quality of life as measured by CFQ-R2 and CRISS3. The trial builds on the successful Phase 1b/2a results, which showed BX004's potential ability to target and destroy P. aeruginosa that conventional treatments failed to eradicate.
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 anticipated timing for reporting results for its clinical assets and whether the results will be positive, as well as the design of clinical trials thereof, potential timing of expected feedback from the FDA, potential approval for BX004, and the potential of its candidates to address the substantial unmet needs of patients with intractable infections and become the leading phage-therapy for CF patients with deadly 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 Lung function measured as FEV1 (Forced Expiratory Volume in 1 second)
2 Cystic Fibrosis Questionnaire-Revised (CFQ-R)
3 Chronic Respiratory Infection Symptom Score (CRISS)
FAQ
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