BiomX to Present Positive Phase 1b/2a Clinical Trial Data for BX004 at the European Respiratory Society (ERS) Congress 2024
BiomX Inc. (NYSE American: PHGE) will present positive Phase 1b/2a clinical trial data for BX004, a novel phage therapy targeting Pseudomonas aeruginosa in cystic fibrosis patients, at the European Respiratory Society Congress 2024. The study demonstrated favorable safety and notable microbiologic and clinical efficacy, even in patients on standard care treatment. Key findings include:
1. Greater reduction in P. aeruginosa colony-forming units in treated subjects vs. placebo
2. 14% of treated subjects had negative P. aeruginosa sputum culture at treatment end
3. Improved lung function in a subgroup of treated patients
4. No treatment-related phage resistance or serious adverse events
BiomX CEO Jonathan Solomon expressed encouragement about the results, highlighting the potential of their novel approach in treating cystic fibrosis.
BiomX Inc. (NYSE American: PHGE) presenterà dati positivi della sperimentazione clinica di Fase 1b/2a per BX004, una nuova terapia bacteriofagica che mira a Pseudomonas aeruginosa nei pazienti affetti da fibrosi cistica, al Congresso della Società Europea di Pneumologia 2024. Lo studio ha dimostrato una sicurezza favorevole e una notevole efficacia microbiologica e clinica, anche in pazienti in trattamento standard. I risultati principali includono:
1. Maggiore riduzione delle unità formanti colonia di P. aeruginosa nei soggetti trattati rispetto al placebo
2. Il 14% dei soggetti trattati ha mostrato una coltura di sputo negativa per P. aeruginosa al termine del trattamento
3. Miglioramento della funzione polmonare in un sottogruppo di pazienti trattati
4. Nessuna resistenza ai fagi correlata al trattamento o eventi avversi gravi
Il CEO di BiomX, Jonathan Solomon, ha espresso ottimismo riguardo ai risultati, sottolineando il potenziale del loro approccio innovativo nel trattamento della fibrosi cistica.
BiomX Inc. (NYSE American: PHGE) presentará datos positivos del ensayo clínico de Fase 1b/2a para BX004, una novedosa terapia bacteriófaga que se dirige a Pseudomonas aeruginosa en pacientes con fibrosis quística, en el Congreso de la Sociedad Europea de Neumología 2024. El estudio demostró una seguridad favorable y una notable eficacia microbiológica y clínica, incluso en pacientes bajo tratamiento estándar. Los hallazgos clave incluyen:
1. Reducción mayor de unidades formadoras de colonias de P. aeruginosa en sujetos tratados en comparación con el placebo
2. El 14% de los sujetos tratados tuvo un cultivo de esputo negativo para P. aeruginosa al final del tratamiento
3. Mejora en la función pulmonar en un subgrupo de pacientes tratados
4. No se observaron resistencias a los fagos relacionadas con el tratamiento ni eventos adversos graves
El CEO de BiomX, Jonathan Solomon, expresó su optimismo sobre los resultados, destacando el potencial de su enfoque innovador en el tratamiento de la fibrosis quística.
BiomX Inc. (NYSE American: PHGE)은 유럽 호흡기학회 Congress 2024에서 섬모체 낭성 섬유증 환자에서 Pseudomonas aeruginosa를 표적으로 하는 새로운 파젠 요법 BX004의 긍정적인 1b/2a 임상시험 데이터를 발표할 예정입니다. 이 연구는 우호적인 안전성과 주목할 만한 미생물학적 및 임상 효능을 입증했으며, 표준 치료를 받는 환자에서도 효과를 보였습니다. 주요 발견사항은 다음과 같습니다:
1. 위약에 비해 치료받은 피험자의 P. aeruginosa 집락 형성 단위가 더 크게 감소
2. 치료 종료 시 치료받은 환자의 14%가 P. aeruginosa의 음성 배양 결과를 보임
3. 치료받은 환자 하위 그룹에서 폐 기능 개선
4. 치료 관련 박테리아 내성 또는 심각한 부작용 없음
BiomX의 CEO인 Jonathan Solomon은 결과에 대해 고무적이라는 의견을 밝히면서, 낭성 섬유증 치료에 있어 그들의 새로운 접근법의 잠재력을 강조했습니다.
BiomX Inc. (NYSE American: PHGE) présentera des données positives d'essai clinique de phase 1b/2a pour BX004, une nouvelle thérapie par phages ciblant Pseudomonas aeruginosa chez des patients atteints de fibrose kystique, lors du Congrès de la Société Européenne de Pneumologie 2024. L'étude a démontré une sécurité favorable et une efficacité microbiologique et clinique remarquable, même chez les patients sous traitement standard. Les principales conclusions incluent :
1. Réduction plus importante des unités formant une colonie de P. aeruginosa chez les sujets traités par rapport au placebo
2. 14% des sujets traités avaient une culture de crachats négative pour P. aeruginosa à la fin du traitement
3. Amélioration de la fonction pulmonaire dans un sous-groupe de patients traités
4. Aucune résistance aux phages liée au traitement ou événements indésirables graves
Le PDG de BiomX, Jonathan Solomon, a exprimé son enthousiasme concernant les résultats, soulignant le potentiel de leur approche novatrice dans le traitement de la fibrose kystique.
BiomX Inc. (NYSE American: PHGE) wird auf dem Kongress der Europäischen Gesellschaft für Pneumologie 2024 positive Daten der klinischen Phase 1b/2a für BX004, einer neuartigen Phagen-Therapie, die sich auf Pseudomonas aeruginosa bei Patienten mit zystischer Fibrose konzentriert, präsentieren. Die Studie zeigte eine günstige Sicherheit sowie bemerkenswerte mikrobiologische und klinische Wirksamkeit, sogar bei Patienten unter Standardbehandlung. Die wichtigsten Ergebnisse umfassen:
1. Größere Reduktion der koloniebildenden Einheiten von P. aeruginosa bei behandelten Probanden im Vergleich zur Placebo-Gruppe
2. 14% der behandelten Probanden hatten am Ende der Behandlung eine negative P. aeruginosa Sputumkultur
3. Verbesserte Lungenfunktion in einer Untergruppe behandelter Patienten
4. Keine behandlungsbezogene Phagenresistenz oder schwerwiegende unerwünschte Ereignisse
Der CEO von BiomX, Jonathan Solomon, äußerte sich ermutigend zu den Ergebnissen und hob das Potenzial ihres neuartigen Ansatzes zur Behandlung von zystischer Fibrose hervor.
- BX004-A demonstrated favorable safety profile in the clinical trial
- 14% of treated subjects had negative P. aeruginosa sputum culture vs 0% in placebo group
- Lung function (FEV1) increased by 5.66% in treated subjects vs -3.23% in placebo for a specific subgroup
- No treatment-related phage resistance observed
- No serious adverse events reported during therapy
- BiomX indicated the need for a longer treatment period to assess enhanced activity
GAITHERSBURG, Md., Sept. 03, 2024 (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, announces the Company will present data from BiomX’s Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections. The findings will be presented as a poster at the European Respiratory Society (ERS) Congress in Vienna, Austria taking place September 7-11, 2024. The poster will be presented on Monday, September 9, 2024, 8:00AM – 9:30AM local time, at Poster Session 234: “Navigating the journey of adult cystic fibrosis: past and future perspectives” (Room PS-21; Board Number 2, Poster ID 2341).
The poster, titled “Novel nebulized phage cocktail in CF patients with chronic P. aeruginosa pulmonary infection: a Ph1b/2a randomized, double-blind, placebo-controlled trial,” reports that the Company’s phage cocktail, BX004-A, demonstrated favorable safety and notable microbiologic and clinical efficacy in cystic fibrosis patients with chronic P. aeruginosa pulmonary infections, including in patients on standard of care treatment of elexacaftor / tezacaftor / ivacaftor (ETI). The poster will be available on the Company’s website following the poster session.
“These data, which encapsulate our previously announced Phase 1b/2a study, continue to be encouraging and support our novel approach to treating cystic fibrosis. The European Respiratory Society is an important opportunity to share these results with the European scientific community, and we are grateful to share these positive data,” commented Jonathan Solomon, BiomX Chief Executive Officer.
Abstract data shows initial results from the two-part study, which will be expanded upon in the poster. In the first part of the study, subjects receiving the BX004-A cocktail showed a greater reduction in P. aeruginosa (PsA) colony-forming units (CFU)/g of sputum at day 15 vs. baseline, compared to placebo. Importantly, in part two of the trial,
About the European Respiratory Society
ERS is one of the leading medical organizations in the respiratory field, with a growing membership spanning over 160 countries. ERS prioritizes science, education and advocacy in order to promote lung health, alleviate suffering from disease and drive standards for respiratory medicine globally.
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 November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial where 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<
BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center Phase 2b trial in CF patients with chronic P. aeruginosa pulmonary infections. The trial is designed to enroll approximately 60 patients randomized at a 2:1 ratio to BX004 or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The trial is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. Pending progress of the trial, results are expected in the third quarter 2025. The U.S. Food and Drug Administration (“FDA”) has granted BX004 Fast Track designation and Orphan Drug Designation.
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 discusses the expected timing and results of clinical trials and the potential efficacy and benefits of BX004, 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. In addition, past and current pre-clinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of BiomX clinical trials. 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. Actual results and outcomes may differ materially from those indicated in the forward-looking statements, as a result of various important factors, including BiomX’s ability to regain compliance with the listing standards set forth in the NYSE American Company Guide; 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. 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. 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 April 4, 2024, 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.
Assaf Oron
+97254-2228901
assafo@biomx.com
CORE IR
Peter Seltzberg
ir-biomx@biomx.com
FAQ
What are the key results of BiomX's Phase 1b/2a trial for BX004 in cystic fibrosis patients?
How did BX004 affect lung function in cystic fibrosis patients during the Phase 1b/2a trial?
When and where will BiomX (PHGE) present the Phase 1b/2a results for BX004?
What is the significance of the 14% negative sputum culture result in the BX004 trial?
