BiomX Provides Update on BX004 Phase 2b Trial for the Treatment of Patients with Cystic Fibrosis
BiomX (NYSE American: PHGE) announced that the FDA has placed a clinical hold on the Phase 2b trial of BX004, their cystic fibrosis treatment. The hold specifically concerns the third-party nebulizer device used for drug delivery, with no issues raised about the BX004 drug candidate itself.
The company has already submitted additional requested data from the nebulizer manufacturer to the FDA. While U.S. patient screening and enrollment are temporarily paused, the European trial continues unaffected as the nebulizer components are CE marked and meet EU regulatory requirements.
BiomX (NYSE American: PHGE) ha comunicato che la FDA ha imposto un clinical hold sullo studio di Fase 2b relativo a BX004, il loro trattamento per la fibrosi cistica. Il blocco riguarda nello specifico il nebulizzatore fornito da terzi utilizzato per la somministrazione del farmaco, senza che siano state sollevate criticità riguardo al candidato farmaco BX004 stesso.
L'azienda ha già trasmesso alla FDA i dati supplementari richiesti dal produttore del nebulizzatore. Mentre in USA lo screening e l'arruolamento dei pazienti sono temporaneamente sospesi, il trial europeo prosegue senza interruzioni poiché i componenti del nebulizzatore sono marcati CE e conformi ai requisiti normativi dell'UE.
BiomX (NYSE American: PHGE) anunció que la FDA ha impuesto un clinical hold en el ensayo de fase 2b de BX004, su tratamiento para la fibrosis quística. La suspensión se refiere específicamente al nebulizador de un tercero usado para la administración del fármaco, y no se han planteado problemas respecto al propio candidato farmacológico BX004.
La compañía ya ha enviado a la FDA los datos adicionales solicitados por el fabricante del nebulizador. Mientras el cribado y la inclusión de pacientes en EE. UU. están temporalmente pausados, el ensayo europeo continúa sin verse afectado, dado que los componentes del nebulizador cuentan con la marca CE y cumplen los requisitos regulatorios de la UE.
BiomX (NYSE American: PHGE)는 FDA가 BX004의 2상 후반(Phase 2b) 임상시험에 대해 임상 중단(clinical hold)을 결정했다고 발표했습니다. 이번 중단은 약물 전달에 사용되는 제3자 네뷸라이저 장치와 관련된 것으로, 후보 약물 BX004 자체에는 문제가 제기되지 않았습니다.
회사는 이미 네뷸라이저 제조업체가 제출한 추가 요청 자료를 FDA에 제출했습니다. 미국 내 환자 스크리닝과 등록은 일시 중단된 반면, 네뷸라이저 구성품이 CE 인증을 받아 EU 규제 요건을 충족하므로 유럽 지역 임상시험은 영향 없이 계속 진행됩니다.
BiomX (NYSE American: PHGE) a annoncé que la FDA a placé un clinical hold sur l'essai de phase 2b de BX004, leur traitement contre la mucoviscidose. La mise en attente concerne spécifiquement le Nébuliseur fourni par un tiers utilisé pour l'administration du médicament, et aucun problème n'a été soulevé à propos du candidat-médicament BX004 lui‑même.
La société a déjà transmis à la FDA les données supplémentaires demandées par le fabricant du nébuliseur. Alors que le dépistage et l'inclusion des patients aux États-Unis sont temporairement suspendus, l'essai européen se poursuit sans être affecté, les composants du nébuliseur étant marqués CE et conformes aux exigences réglementaires de l'UE.
BiomX (NYSE American: PHGE) gab bekannt, dass die FDA ein clinical hold für die Phase-2b-Studie von BX004, ihrer Behandlung für Mukoviszidose, verhängt hat. Die Maßnahme betrifft ausdrücklich das Neubulizer-Gerät eines Drittanbieters, das zur Verabreichung des Medikaments verwendet wird; zum Arzneistoffkandidaten BX004 selbst wurden keine Bedenken geäußert.
Das Unternehmen hat der FDA bereits die zusätzlich angeforderten Daten des Nebulizer-Herstellers vorgelegt. Während in den USA das Screening und die Einschreibung von Patienten vorübergehend ausgesetzt sind, läuft die Studie in Europa unbeeinträchtigt weiter, da die Nebulizer-Bauteile CE-zertifiziert sind und den EU-Vorschriften entsprechen.
- No concerns raised by FDA regarding the BX004 drug candidate itself
- European trials continue unaffected due to CE marked nebulizer components
- Company has already submitted requested nebulizer data to FDA
- Clinical hold placed on Phase 2b trial in the U.S.
- Patient screening and enrollment paused in U.S. portion of the trial
- Potential delays in U.S. trial timeline due to regulatory review
Insights
FDA clinical hold on BiomX's CF therapy affects US trial progress while European enrollment continues; issue centers on delivery device, not the drug.
The FDA has placed a clinical hold on BiomX's Phase 2b trial for BX004, their phage therapy targeting cystic fibrosis (CF). This regulatory action specifically concerns the third-party nebulizer device used to deliver the therapy, not the BX004 drug candidate itself, which has already received FDA clearance for investigational use.
This distinction is crucial - the hold appears to be a technical device issue rather than a safety or efficacy concern with the phage therapy. BiomX has responded promptly by submitting additional data from the nebulizer's manufacturer to address the FDA's questions. The company characterizes the hold as likely temporary.
While US patient screening and enrollment are now paused, the European arm of the study continues unaffected. This is because in Europe, all components of the nebulizer already have CE marking, meaning they meet applicable regulatory requirements in that jurisdiction.
Clinical holds can introduce varying degrees of delay to development timelines depending on the complexity of the issues involved. However, when holds relate to delivery devices rather than the investigational drug itself, they typically represent lower regulatory hurdles. The fact that European enrollment continues provides some risk mitigation for the overall clinical program.
For a company focused on novel phage therapies targeting specific bacteria, maintaining momentum in clinical development is essential, particularly in a condition like cystic fibrosis where bacterial infections contribute significantly to disease progression.
U.S. FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004; no concerns were raised in the clinical hold notification regarding the BX004 drug candidate
Enrollment and dosing of patients outside the US is continuing in accordance with protocol
NESS ZIONA, Israel, Aug. 19, 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 the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase 2b trial of BX004 for the treatment of patients with cystic fibrosis (CF).
In its notification, the FDA solely focused on the third-party nebulizer device utilized to deliver BX004. The BX004 drug product candidate has already been reviewed by the FDA and has been cleared for clinical investigational use with no concerns indicated to BiomX. Following the FDA’s hold notification, which the company believes to be temporary, BiomX promptly submitted the additional requested data which was generated independently by the well-established manufacturer of the nebulizer device, and this data is expected to provide the information required by the FDA to lift the hold. As a result of the FDA’s notification, patient screening and enrollment in the U.S. portion of the Phase 2b trial of BX004 have now been paused. In Europe, all components of the third-party nebulizer device are CE marked and thus have been deemed to meet applicable regulatory requirements. The study in the EU has been approved and enrollment and dosing of patients is continuing in accordance with the protocol.
“We are actively engaged with the FDA to promptly address their queries regarding the third-party nebulizer,” said Jonathan Solomon, Chief Executive Officer of BiomX. “Importantly, the FDA’s notification relates solely to the nebulizer, and we remain optimistic and confident that in response to the hold, we have provided the FDA with data that can satisfactorily support the use of the nebulizer and that this can be resolved promptly so that we may resume treating patients with cystic fibrosis in the U.S., BiomX remains committed to providing timely updates and full transparency to patients, physicians, and investors as the situation develops.”
About BX004
BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (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 the clinical hold imposed by the FDA, the possibility that the data BiomX provided will allow the FDA to lift such clinical hold, that such clinical hold will be lifted soon, if at all, the timing, process and potential outcomes of review and other measures by the European regulatory authorities, resumption of patient enrollment and timing thereof and the impact of the FDA clinical hold on the BX004 Phase 2b trial, 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
Why did the FDA place a clinical hold on BiomX's (PHGE) Phase 2b trial?
Is BiomX (PHGE) still conducting the BX004 Phase 2b trial in Europe?
What steps has BiomX (PHGE) taken to address the FDA clinical hold?
Does the FDA clinical hold affect the BX004 drug candidate's safety profile?
When will BiomX (PHGE) resume the Phase 2b trial in the United States?
