BiomX Announces Positive Topline Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO)
BiomX (NYSE: PHGE) announced positive topline results from its Phase 2 trial of BX211 for treating Diabetic Foot Osteomyelitis (DFO). The trial demonstrated that BX211 was safe and well-tolerated, producing statistically significant improvements in multiple areas:
- Sustained reduction in ulcer size (PAR) with p=0.046 at week 12
- Significant improvements in ulcer depth at week 13 (p=0.048)
- Reduced expansion of ulcer area (p=0.017)
The study involved 41 patients randomized at a 2:1 ratio, with 26 receiving BX211 and 15 receiving placebo. Treatment showed separation from placebo starting at week 7, with a difference greater than 40% by week 10. The company is now planning for a Phase 2/3 trial, pending FDA feedback.
BiomX (NYSE: PHGE) ha annunciato risultati positivi preliminari dal suo studio di Fase 2 su BX211 per il trattamento dell'Osteomielite del Piede Diabetico (DFO). Lo studio ha dimostrato che BX211 è stato sicuro e ben tollerato, producendo miglioramenti statisticamente significativi in diverse aree:
- Riduzione sostenuta delle dimensioni dell'ulcera (PAR) con p=0.046 alla settimana 12
- Miglioramenti significativi nella profondità dell'ulcera alla settimana 13 (p=0.048)
- Riduzione dell'espansione dell'area dell'ulcera (p=0.017)
Lo studio ha coinvolto 41 pazienti randomizzati in un rapporto di 2:1, con 26 che hanno ricevuto BX211 e 15 che hanno ricevuto un placebo. Il trattamento ha mostrato una separazione dal placebo a partire dalla settimana 7, con una differenza superiore al 40% entro la settimana 10. L'azienda sta ora pianificando uno studio di Fase 2/3, in attesa del feedback della FDA.
BiomX (NYSE: PHGE) anunció resultados preliminares positivos de su ensayo de Fase 2 sobre BX211 para el tratamiento de la Osteomielitis del Pie Diabético (DFO). El ensayo demostró que BX211 fue seguro y bien tolerado, produciendo mejoras estadísticamente significativas en varias áreas:
- Reducción sostenida del tamaño de la úlcera (PAR) con p=0.046 en la semana 12
- Mejoras significativas en la profundidad de la úlcera en la semana 13 (p=0.048)
- Reducción de la expansión del área de la úlcera (p=0.017)
El estudio involucró a 41 pacientes aleatorizados en una proporción de 2:1, con 26 recibiendo BX211 y 15 recibiendo un placebo. El tratamiento mostró separación del placebo a partir de la semana 7, con una diferencia superior al 40% para la semana 10. La empresa ahora está planeando un ensayo de Fase 2/3, a la espera de comentarios de la FDA.
BiomX (NYSE: PHGE)는 BX211의 당뇨병성 발 골수염(DFO) 치료를 위한 2상 시험에서 긍정적인 초기 결과를 발표했습니다. 이 시험은 BX211이 안전하고 잘 견딜 수 있으며 여러 분야에서 통계적으로 유의미한 개선을 나타냈음을 보여주었습니다:
- 12주차에 p=0.046으로 궤양 크기의 지속적인 감소(PAR)
- 13주차에 궤양 깊이의 유의미한 개선(p=0.048)
- 궤양 면적의 확장 감소(p=0.017)
이 연구는 41명의 환자를 2:1 비율로 무작위 배정하였으며, 26명이 BX211을, 15명이 위약을 받았습니다. 치료는 7주차부터 위약과의 차별화를 보였으며, 10주차까지 40% 이상의 차이를 보였습니다. 회사는 현재 FDA의 피드백을 기다리며 2/3상 시험을 계획하고 있습니다.
BiomX (NYSE: PHGE) a annoncé des résultats préliminaires positifs de son essai de Phase 2 sur BX211 pour le traitement de l'Ostéomyélite du Pied Diabétique (DFO). L'essai a démontré que BX211 était sûr et bien toléré, produisant des améliorations statistiquement significatives dans plusieurs domaines :
- Réduction soutenue de la taille de l'ulcère (PAR) avec p=0.046 à la semaine 12
- Améliorations significatives de la profondeur de l'ulcère à la semaine 13 (p=0.048)
- Réduction de l'expansion de la surface de l'ulcère (p=0.017)
L'étude a impliqué 41 patients randomisés dans un rapport de 2:1, avec 26 recevant BX211 et 15 recevant un placebo. Le traitement a montré une séparation par rapport au placebo à partir de la semaine 7, avec une différence supérieure à 40 % d'ici la semaine 10. L'entreprise prévoit maintenant un essai de Phase 2/3, en attente des retours de la FDA.
BiomX (NYSE: PHGE) hat positive vorläufige Ergebnisse aus seiner Phase-2-Studie zu BX211 zur Behandlung der diabetischen Fußosteomyelitis (DFO) bekannt gegeben. Die Studie zeigte, dass BX211 sicher und gut verträglich war und statistisch signifikante Verbesserungen in mehreren Bereichen erzielte:
- Nachhaltige Reduktion der Geschwürgröße (PAR) mit p=0.046 in Woche 12
- Signifikante Verbesserungen der Geschwürtiefe in Woche 13 (p=0.048)
- Verringerung der Ausdehnung des Geschwürbereichs (p=0.017)
Die Studie umfasste 41 Patienten, die im Verhältnis 2:1 randomisiert wurden, wobei 26 BX211 und 15 ein Placebo erhielten. Die Behandlung zeigte ab Woche 7 eine Trennung vom Placebo, mit einem Unterschied von über 40% bis Woche 10. Das Unternehmen plant nun eine Phase-2/3-Studie, die auf das Feedback der FDA wartet.
- Achieved statistically significant efficacy endpoints in Phase 2 trial
- Demonstrated safety and tolerability in clinical testing
- Showed effectiveness against both antibiotic-resistant and susceptible strains
- Advancing to Phase 2/3 trial pending FDA feedback
- Addresses large market with 160,000 annual lower limb amputations in US
- Marginal statistical significance at week 13 (p=0.052)
- Still requires FDA approval to proceed with Phase 2/3 trial
- Additional clinical trials needed before potential commercialization
Insights
BiomX's positive Phase 2 results for BX211 represent a significant milestone in the development of phage therapy, an innovative approach targeting bacterial infections where traditional antibiotics often fail. The data showing statistically significant reduction in ulcer size (p=0.046 at week 12) with separation from placebo starting at week 7 demonstrates meaningful clinical benefit in diabetic foot osteomyelitis (DFO).
What's particularly noteworthy is BX211's efficacy against both methicillin-susceptible and resistant strains, highlighting phage therapy's orthogonal mechanism to antibiotics. This addresses a critical unmet need in an era of increasing antimicrobial resistance. The improvements in ulcer depth (p=0.048) and reduction in ulcer area expansion (p=0.017) further validate the therapeutic potential.
The advancement to Phase 2/3 trial planning signals regulatory confidence and accelerates BiomX's development timeline. For a micro-cap company (
With 160,000 lower limb amputations in diabetic patients annually in the US and 30-40% of DFO cases leading to amputation, BX211 addresses a substantial market with effective treatment options. This positions BiomX at the forefront of the emerging phage therapeutics field.
The BX211 Phase 2 results represent a potential breakthrough in DFO treatment, a condition with devastating consequences and therapeutic options. The statistically significant reduction in ulcer size compared to standard of care is clinically meaningful, especially considering the 40% difference by week 10 that was sustained through the study.
Current DFO management relies heavily on systemic antibiotics with suboptimal outcomes. The data showing efficacy against both antibiotic-susceptible and resistant strains addresses a critical clinical challenge. Additionally, the demonstrated anti-biofilm capabilities target a key pathogenic mechanism in chronic wound infections that conventional antibiotics struggle to penetrate.
The improvements in ulcer depth for patients with bone exposure at baseline is particularly important, as bone involvement significantly increases amputation risk. The trial design strength - randomized, double-blind, placebo-controlled with all patients receiving standard of care - provides robust evidence for BX211's efficacy beyond current treatments.
The five-year mortality rate of approximately 50% following lower extremity amputation underscores the life-saving potential of effective DFO treatments. If the efficacy demonstrated in this trial translates to reduced amputations in larger studies, BX211 could fundamentally change the management paradigm for these complex infections and significantly improve patient outcomes. The safety profile further supports its potential as a much-needed addition to the DFO treatment armamentarium.
- BX211 was safe and well-tolerated
- BX211 produced sustained and statistically significant1 Percent Area Reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than
40% by week 10 - Compared to placebo, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of ulcer area (p=0.017).
- BiomX is planning for a Phase 2/3 trial of BX211, pending U.S. Food and Drug Administration (FDA) feedback
The Company will host a conference call and webcast today at 9:00 AM ET, followed by a Key Opinion Leader (KOL) event on April 3, 2025, at 11:00 AM ET to discuss the results
NESS ZIONA, Israel, March 31, 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 positive, topline safety and efficacy results from the Company’s DFO Adaptive Novel Care Evaluation (DANCE™) Phase 2 trial evaluating its BX211 phage treatment for DFO associated with Staphylococcus aureus (S. aureus). The findings demonstrated BX211 to be safe and well-tolerated and that patients receiving BX211 exhibited statistically significant1 and sustained reduction of ulcer size (PAR) (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than
"We believe these data represent one of the strongest demonstrations to date of the therapeutic potential of phage therapy. We are grateful to all the patients who participated, and the treating teams who enrolled patients into the study, as well as the continued and ongoing support from the U.S. Defense Health Agency (DHA) for this program,” said Jonathan Solomon, BiomX’s Chief Executive Officer. “Today, 30
“Phage therapy has a critical role to play in treating infections where antibiotic resistance has emerged or existing treatments have underperformed,” said Dr. Robert T. “Chip” Schooley, M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co-Director, Center for Innovative Phage Applications and Therapeutics at the University of California, San Diego. “The promising topline data in this trial provide an important inflection point for this approach and its potential to address the most challenging infections.”
“Diabetic foot infections are often a complex and difficult-to-treat consequence of diabetes, leading to serious adverse effects on patient quality of life,” said Dr. Benjamin A. Lipsky, M.D., FACP, FIDSA, FRCP (London), FRCPS (Glasgow), Professor of Medicine Emeritus at University of Washington, Seattle. “The most serious and feared complication of DFO is lower extremity amputation, which is associated with a five-year mortality rate of about
Summary of Phase 2 BX211 Results
BiomX’s Phase 2 trial is a randomized, double-blind, placebo-controlled, multi-center study investigating the safety, tolerability, and efficacy of BX211 for individuals with DFO associated with S. aureus. The study enrolled a total of 41 patients randomized for treatment at a 2:1 ratio, 26 of whom received intravenous (IV) and topical administration of BX211 on week 1 followed by a topical weekly dose through week 12, while 15 patients were assigned to the placebo arm. Over the 12-week treatment period, all subjects (treatment and placebo) were also treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. A readout of study results at week 13 evaluated healing of the wound associated with osteomyelitis. The primary efficacy endpoint was PAR of study ulcer through week 13. Study design was guided in part by experience with numerous compassionate cases using phage therapy for the treatment of DFO and osteomyelitis.
The topline Phase 2 results included:
- BX211 was found to be safe and well-tolerated.
- BX211 produced sustained and statistically significant1 PAR of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo (standard of care) starting at week 7 and a difference greater than
40% by week 10. - BX211 produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of ulcer area (p=0.017), compared to placebo.
- BX211 demonstrated favorable trends compared to placebo across several additional clinical parameters, including: proportion of visits with no clinical evidence of infection; evidence of resolving DFO by MRI/X-ray at week 12; proportion of patients with abnormal C-Reactive Protein at baseline that achieved a reduction of CRP of at least
50% at any point in the study; and greater Wagner scale improvement2. - Through week 13, BX211 demonstrated comparable efficacy against both Methicillin-susceptible and resistant strains, as well as against high and low biofilm producers—consistent with the orthogonal mechanism of phage therapy to antibiotics and its inherent anti-biofilm capabilities.
BiomX expects to present additional data from the Phase 2 study at upcoming scientific conferences.
Today’s Conference Call and Webcast Information
BiomX management will host a conference call and webcast today at 9:00 AM ET to review the topline Phase 2 trial results, accompanied by a slide deck presentation, which will be available on the Company's website and filed via Form 8-K. To participate in the conference, please dial +877-407-0724 (U.S.), or +1 201-389-0898 (International), or click on the webcast link here.
A live and archived webcast of the call will also be available on the Investors section of the Company’s website at www.biomx.com.
BiomX to Host Virtual KOL Event – April 3, 2025
The Company has scheduled a virtual KOL Event to discuss the topline results from the Phase 2 trial. The event will take place on April 3, 2025, at 11:00 am ET, and will include participation from BiomX senior management and two KOLs, Dr. Robert T. “Chip” Schooley, M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co-Director, Center for Innovative Phage Applications and Therapeutics at the University of California, San Diego, and Dr. Benjamin A. Lipsky, M.D., FIDSA, FRCP (London), FRCPS (Glasgow) Professor of Medicine Emeritus at University of Washington, Seattle. To register for the event, please click here.
About BX211
BX211 is a phage treatment for the treatment of DFO associated with S. aureus. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. Pending feedback from the FDA, BiomX is planning for a Phase 2/3 clinical trial of BX211.
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 safety and toleration of BX211, the potential benefits of BX211, future clinical development of BX211 and the relevance and potential of phage therapy in the treatment of chronic 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; 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
1 All p-values described in this release are non-adjusted
2 The Wagner Scale is a clinical grading system used to classify the severity of diabetic foot ulcers, ranging from 0 (intact skin) to 5 (extensive gangrene).
FAQ
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