BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

BX004 showed clinically meaningful improvement in pulmonary function as measured in FEV1¹ and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain in a predefined subgroup of patients with reduced lung function²

Treatment with BX004 also achieved P. aeruginosa culture conversion to negative at end of 10 days of treatment in 3 patients (14%) versus none for placebo³

In a prespecified subgroup of patients on background use of continuous inhaled antibiotics, BX004 showed a 2.8 log₁₀ CFU/g¹ reduction in P. aeruginosa burden at end of treatment versus placebo, exceeding Part 1 results

BX004 therapy was safe and well-tolerated

Plans to advance BX004 program into pivotal Phase 2b/3 trial

Company to host webcast/cc to discuss Part 2 data today at 9:00 am ET; Key Opinion Leader (KOL) event scheduled for December 4, 2023, at 12:00 pm ET

CAMBRIDGE, Mass. and NESS ZIONA, Israel, Nov. 29, 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 positive safety and efficacy results from 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”).

“These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX. “In Part 2 of the study, BX004 showed clinically meaningful improvement in pulmonary function compared to placebo, as measured by relative FEV1¹ improvement (5.67% at Day 17, 1 week after end of treatment) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain (8.87 points at Day 17) in a predefined subgroup of patients with reduced lung function².”

“Reduction in P. aeruginosa bacterial burden was also observed. 3 of 21 (14%) BX004-treated patients converting to a negative P. aeruginosa sputum culture at end of treatment (Day 10) versus 0 of 10 (0%) in the placebo arm³ – an impressive result considering that these three patients had P. aeruginosa lung infections for 10 years or longer and the short treatment duration,” said Eitan Kerem, M.D., Professor of Pediatrics and former Chairman of the Department of Pediatrics and the Pediatric Pulmonology Unit of the Hadassah University Medical Center in Jerusalem and former board member of the European Cystic Fibrosis Society. “Although there was variability in the mean P. aeruginosa levels in the entire study population, in a prespecified subgroup of patients on standard of care inhaled antibiotics on continuous regimen, at end of treatment (Day 10), the mean P. aeruginosa burden was reduced by 2.91 log₁₀ CFU/g in the treatment group compared to 0.11 log₁₀ CFU/g in those receiving placebo. This exceeded the reduction observed in Part 1 of the trial.”