BiomX to Present Part 1 Data from Phase 1b/2a Study Evaluating BX004 for the Treatment of Chronic Pseudomonas aeruginosa Pulmonary Infections in Patients with Cystic Fibrosis During Late-Breaking Science Session at the 46th European Cystic Fibrosis Conference (ECFC)
CAMBRIDGE, Mass. and NESS ZIONA, Israel, May 31, 2023 (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 that the Company will present Part 1 data from its ongoing Phase 1b/2a study evaluating the novel phage product candidate, BX004, for the treatment of chronic Pseudomonas aeruginosa (PsA) pulmonary infections in patients with cystic fibrosis (“CF”) during the Late-Breaking Science Session at 46th European Cystic Fibrosis Conference (ECFC), which is being held June 7-10th, 2023, in Vienna, Austria.
The Phase 1b/2a data will also be presented as a poster at the conference; posters will be located in Foyers E and F on Level 0.
Details of the oral presentation are as follows:
Title: A phase 1b/2a randomized, double-blind, placebo-controlled, multicenter study evaluating nebulized phage therapy in cystic fibrosis subjects with chronic Pseudomonas aeruginosa pulmonary infection
Workshop 15 – Late-Breaking Science
Date and Time: Friday, June 9, 2023, 17:00-17:30 CEST
Presenter: Dr. Urania Rappo, BiomX Inc., Cambridge, United States
The poster will also be made available on the publications section of the BiomX website on Friday, June 9th at 17:00 CEST.
BiomX is developing BX004, utilizing its proprietary BOLT platform, 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 September 2021, BX004 was cleared by the U.S. Food and Drug Administration to initiate a Phase 1b/2a study in CF patients with chronic pulmonary infections caused by P. aeruginosa. Part 2 of the Phase 1b/2a study of BX004 will evaluate the safety and efficacy of BX004 in 24 CF patients with chronic pulmonary infection caused by P. aeruginosa randomized to treatment or placebo in a 2:1 ratio. Results from Part 2 are expected in the third quarter of 2023.
BiomX is a clinical-stage company developing both natural and engineered phage cocktails 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 www.biomx.com, the content of which does not form a part of this press release.
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 potential safety or efficacy of BX004, and the expected timing , design and patient enrollment of Part 2 of the Phase 1b/2a study, 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. 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. 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 29, 2023 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.
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Corporate Project Manager
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Source: BiomX Inc.
Released May 31, 2023