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BiomX to Present Data From Phase 1b/2a Study of BX004 for the Treatment of Cystic Fibrosis Patients With Chronic Pulmonary Infections at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024)

BiomX to Present Data From Phase 1b/2a Study of BX004 for the Treatment of Cystic Fibrosis Patients With Chronic Pulmonary Infections at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024)

BiomX 将在第 34 届欧洲临床微生物学和传染病大会(ECCMID 2024)上公布用于治疗慢性肺部感染囊性纤维化患者的 BX004 1b/2a 期研究的数据
GlobeNewswire ·  04/23 08:00

Abstract selected as a "Top Poster", ranking it among the 1-2% of top-rated abstracts in the category submitted and accepted at ECCMID 2024

摘要被选为 “最佳海报”,在2024年ECCMID上提交和接受的类别中排名最高的摘要中名列前茅 1-2%

CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 23, 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, today announced the Company will present data from the Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections at ECCMID 2024, which is being held from 27-30 April 2024, in Barcelona, Spain. The abstract submitted by the Company was selected as a "Top Poster", ranking it among the 1-2% of top-rated abstracts in the category submitted and accepted at ECCMID 2024.

马萨诸塞州剑桥和以色列内斯齐奥纳,2024 年 4 月 23 日(环球新闻社)—— BiomX Inc.(纽约证券交易所美国股票代码:PHGE)(“BiomX” 或 “公司”)是一家临床阶段的公司,推进针对特定致病细菌的新型天然和工程噬菌体疗法,今天宣布,该公司将提供用于治疗慢性囊性纤维化患者的 BX004 1b/2a 期研究的数据 铜绿假单胞菌 将于2024年4月27日至30日在西班牙巴塞罗那举行的ECCMID 2024期间的肺部感染。公司提交的摘要被选为 “最佳海报”,在ECCMID 2024上提交和接受的类别中排名前列的1-2%的摘要之列。

Details of the presentation:

演示详情:

Title: Chronic Pseudomonas aeruginosa pulmonary infection treated with a nebulised phage cocktail in patients with cystic fibrosis: a phase 1b/2a randomised, double-blind, placebo-controlled, multicentre study
Poster number: P2546
Session type: Poster Session
Session title: 5c. New or repurposed antibacterial agents: clinical studies and randomized trials
Session date: April 28, 2024
Session time/location: 12:00-13:30 CEST in Poster Area
Presenter: Urania Rappo, MD, BiomX Inc., Cambridge, MA, United States
The poster will also be made available as an ePoster for viewing by delegates on the ECCMID virtual platform during ECCMID 2024 and in the publications section of the BiomX website.
标题: 慢性 铜绿假单胞菌 使用雾化噬菌体混合物治疗囊性纤维化患者的肺部感染:1b/2a期随机、双盲、安慰剂对照、多中心研究
海报编号: P2546
会话类型: 海报发布会
会议标题: 5c。新的或再利用的抗菌药物:临床研究和随机试验
会话日期: 2024年4月28日
会话时间/地点: CEST 12:00-13:30 在海报区
演示者: 美国马萨诸塞州剑桥 BiomX Inc. 医学博士 Urania Rappo
该海报还将作为电子海报提供,供代表们在ECCMID 2024年期间在ECCMID虚拟平台上以及在BioMX网站的出版物部分观看。

About BX004
BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of cystic fibrosis ("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 function1.

关于 BX004
BiomX 正在开发 BX004,一种固定的多噬菌体混合物,用于治疗由以下原因引起的慢性肺部感染的囊性纤维化(“CF”)患者 铜绿假单胞菌,是造成 CF 患者发病率和死亡率的主要因素。2023 年 11 月,BiomX 宣布了 1b/2a 期试验第 2 部分的积极结果,其中 BX004 显示肺功能有所改善,与肺功能减少有关 铜绿假单胞菌 在预定义的肺功能减退患者亚组中,与安慰剂相比的负担1

BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center Phase 2b trial in CF patients with chronic P. aeruginosa pulmonary infections in the fourth quarter of 2024. The trial is designed to enroll approximately 60 patients randomized in 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 demonstrate microbiologic reduction of P. aeruginosa burden in sputum and evaluate clinical parameters such as lung function measured by FEV1 and patient reported outcomes, as well as monitor the safety and tolerability of BX004. Trial results are expected in the third quarter 2025. The Food and Drug Administration ("FDA") has granted BX004 Fast Track designation and Orphan Drug Designation.

BiomX 预计将启动一项针对慢性 CF 患者的随机、双盲、安慰剂对照、多中心 2b 期试验 铜绿假单胞菌 2024年第四季度的肺部感染。该试验旨在招收大约 60 名患者,其比例与 BX004 或安慰剂的比例为 2:1。预计将通过吸入进行治疗,每天两次,持续8周。该试验旨在证明微生物学还原性 铜绿假单胞菌 痰液负担,评估临床参数,例如 FEV1 测量的肺功能和患者报告的预后,并监测 BX004 的安全性和耐受性。试验结果预计将在2025年第三季度公布。美国食品药品监督管理局(“FDA”)已授予 BX004 快速通道认证和孤儿药称号。

About BiomX
BiomX is a clinical-stage company developing both natural and engineered phage cocktails and personalized phage treatments designed to target and destroy bacteria in the treatment of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets. For more information, please visit , the content of which does not form a part of this press release.

关于 BiomX
BiomX 是一家处于临床阶段的公司,开发天然和工程噬菌体混合物以及个性化噬菌体疗法,旨在靶向和消灭慢性病治疗中的细菌。BiomX 发现并验证专有的细菌靶标,并针对这些靶标定制噬菌体成分。欲了解更多信息,请访问,其内容不构成本新闻稿的一部分。

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 of clinical trials, key data readouts and topline results and the potential benefits of BX004, BiomX is making 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 risks and uncertainties related to the ability to recognize the anticipated benefits of the acquisition of Adaptive Phage Therapeutics, Inc.; the outcome of any legal proceedings that may be instituted against BiomX following the acquisition and related transactions; the ability to obtain or maintain the listing of the common stock of BiomX on the NYSE American following the acquisition; costs related to the acquisition; 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 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.

安全港
本新闻稿包含1995年美国私人证券诉讼改革法案中 “安全港” 条款所指的明示或暗示的 “前瞻性陈述”。前瞻性陈述可以通过诸如 “目标”、“相信”、“期望”、“将”、“可能”、“预测”、“估计”、“将”、“定位”、“未来” 等词语来识别,以及其他预测或表明未来事件或趋势或非历史问题陈述的类似表达。例如,当 BiomX 讨论临床试验的预期时机、关键数据读数和关键结果以及 BX004 的潜在好处时,BiomX 正在发表前瞻性陈述。前瞻性陈述既不是历史事实,也不是对未来表现的保证。相反,它们仅基于BiomX管理层当前的信念、期望和假设。此外,过去和当前的临床前和临床结果以及同情心的使用都不是指示性的,也不能保证 BiomX 临床试验未来的成功。由于前瞻性陈述与未来有关,因此它们会受到固有的不确定性、风险和环境变化的影响,这些变化难以预测,其中许多是BiomX无法控制的。由于各种重要因素,包括与确认收购Adaptive Phage Therapeutics, Inc. 的预期收益的能力相关的风险和不确定性;收购和关联交易后可能对BiomX提起的任何法律诉讼的结果;收购成本之后获得或维持BioMx普通股在美国纽约证券交易所上市的能力;实际结果和结果可能与前瞻性陈述中显示的结果存在重大差异;收购成本之后获得或维持BioMx普通股在美国证券交易所上市的能力;与收购;适用法律或法规的变化;BiomX 可能受到其他经济、商业和/或竞争因素不利影响的可能性,包括药物研发固有的风险,例如:BiomX 药物发现、临床前和临床开发活动的不良结果、临床前研究和早期临床试验的结果可能无法在以后的临床试验中复制的风险、BiomX 招募患者参与临床试验的能力以及任何风险其临床试验可能不是启动、继续或按时或完全完成;美国食品和药物管理局和其他监管机构做出的决定;临床试验场所的研究审查委员会和出版物审查机构与我们的开发候选人有关的研究审查委员会;BiomX获得、维护和执行其平台和开发候选人知识产权的能力;其对合作伙伴的潜在依赖;竞争;BiomX的现金资源是否足以为预期时期的计划活动提供资金的不确定性以及BiomX 的能力管理计划外的现金需求;以及总体经济和市场状况。因此,投资者不应依赖任何前瞻性陈述,应审查BiomX于2024年4月4日向美国证券交易委员会(“SEC”)提交的10-K表年度报告中 “风险因素” 标题下描述的风险和不确定性,以及BiomX在向美国证券交易委员会提交的其他文件中作出的额外披露,这些文件可在美国证券交易委员会网站www.sec.gov上查阅。前瞻性陈述自本新闻稿发布之日起作出,除非法律另有规定,否则BiomX明确表示不承担任何更新前瞻性陈述的义务或承诺。

BiomX Contacts
Investor Relations:
LifeSci Advisors, LLC
John Fraunces
Managing Director
(917) 355-2395
jfraunces@lifesciadvisors.com, or
Brian Mullen
LifeSci Advisors, LLC
(203) 461-1175
Bmullen@lifesciadvisors.com

BiomX 联系人
投资者关系:
LifeSci 顾问有限公司
约翰·弗朗西斯
董事总经理
(917) 355-2395
jfraunces@lifesciadvisors.com,或
布莱恩·马伦
LifeSci 顾问有限公司
(203) 461-1175
Bmullen@lifesciadvisors.com

BiomX, Inc.
Assaf Oron
Chief Business Officer
assafo@biomx.com
Source: BiomX Inc.

BiomX, Inc.
Assaf Oron
首席商务官
assafo@biomx.com
资料来源:BiomX Inc.


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