Company remains on track to report Part 2 results from the study in November 2023

Part 1 data of the Phase 1b/2a study accepted for oral presentation at upcoming IDWeek 2023

CAMBRIDGE, Mass. and NESS ZIONA, Israel, Oct. 04, 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 the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”). The Company remains on track to report results from Part 2 of the study in November 2023.

“BX004 has been designed to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections,” said Jonathan Solomon, Chief Executive Officer of BiomX. “With patient dosing now complete in Part 2 of our Phase 1b/2a study, we remain on track to announce results next month. I am also pleased to note that our two late-breaker, oral presentations highlighting our Part 1 results were well received by the CF community at the recent European Cystic Fibrosis Society (ECFS) conference and European Respiratory Society (ERS) Congress, further underscoring clinician and patient interest in the BX004 program. The Part 1 data has also been accepted as a late-breaker, oral presentation at the upcoming IDWeek 2023 meeting, which should provide another important venue for building awareness of the BX004 program.”

Details of the oral presentation of the Part 1 data are as follows:

Conference: IDWeek 2023
Session Title: Late Breaking Abstracts: Clinical Trials
Session Type: Oral Abstract
Session Date: Saturday October 14, 2023
Session Time: 1:45 PM - 3:00 PM ET
Location: 254 AB
Presentation Title: (2891) Nebulized Phage Therapy for Patients with Cystic Fibrosis with Chronic Pseudomonas aeruginosa Pulmonary Infection: A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Presenter: Urania Rappo, MD, BiomX Inc., Cambridge, United States
Presentation Time: 2:21 PM - 2:33 PM ET

About BX004
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 (“FDA”) to initiate a Phase 1b/2a study in CF patients with chronic pulmonary infections caused by P. aeruginosa. The Phase 1b/2a trial is composed of two parts. In February 2023, the Company reported positive results from Part 1 of the study which evaluated the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in nine CF patients in a single ascending dose and multiple dose design. Part 2 of the study will evaluate the safety and efficacy of BX004 in at least 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 of the trial are expected in November 2023. In August 2023, the FDA granted BX004 Fast Track designation for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa (PsA) bacterial strains in patients with CF.