A study evaluating phage therapy in cystic fibrosis subjects with Pseudomonas aeruginosa Infection.
Jenia Gold 2, Urania Rappo 1, Maya Kahan-Hanum 2, Xilla Ussery 1, Edith Kario 2, Hadas Tamar Nevenzal 2, Iddo Nadav Weiner 2, Jagoda Jablonska 2, Nufar Buchshtab 2, Ori Bahar 2, Vered Lev 2, Yaron Tzur 2, Yulia Zarchin 2, Myriam Golembo 2, Regis Vilchez 1, Eitan Kerem 3, Merav Bassan 2
- BiomX Inc., Cambridge, Massachusetts, US
- BiomX Ltd, Ness Ziona, Israel
- Department of Pediatrics and CF Center, Hadassah University Hospital, Jerusalem, Israel
Introduction: Cystic fibrosis (CF) is a genetic disease that sensitizes the lungs to life threatening bacterial infections and thus requires chronic antibiotic use. Pseudomonas aeruginosa (PsA) is a notorious antibiotic-resistant pathogen associated with morbidity and mortality of CF patients. Bacteriophage therapy offers a novel alternative or adjunctive option to antibiotics in chronic PsA infections.
Objective: The objective of this phase 1b/2a study was to assess the safety and tolerability of nebulized phage (BX004) and its effect on sputum PsA burden.
Methodology: Nine CF patients chronically infected with PsA were enrolled in Part 1 of an ongoing phase 1b/2a double-blinded placebo-controlled clinical trial. Seven patients received ascending doses of BX004 whereas two patients received placebo. All patients received their standard-of-care antibiotic treatment during the trial.
Results: BX004 was safe and well-tolerated. Furthermore, patients treated with phage showed an average log 1.42 CFU/g reduction in PsA sputum density compared to baseline, whereas the reduction from baseline in the placebo group was log 0.28 CFU/g.
Conclusions: These data pave the way toward the establishment of novel phage-based inhaled therapeutics for chronic PsA infections in CF.