BiomX has completed the dosing of patients with cystic fibrosis (CF) in Part II of its Phase Ib/IIa clinical trial of BX004 to treat chronic pulmonary infections caused by Pseudomonas aeruginosa.

Part II of the study will assess the efficacy and safety of BiomX’s new phage cocktail BX004 in at least 24 patients with CF.

They will be randomised into a 2:1 ratio to receive BX004 treatment or placebo.

BiomX CEO Jonathan Solomon said: “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.

“With patient dosing now complete in Part II of our Phase Ib/IIa study, we remain on track to announce results next month.”

In Part I of the study, the microbiologic/clinical activity, pharmacokinetics and safety of BX004 were evaluated in nine CF patients in a single ascending dose and multiple dose design.

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By GlobalData

The company announced positive results from this part in February.

In August, the US Food and Drug Administration granted fast-track designation to the therapy to treat chronic respiratory infections.

Last June, BiomX announced a collaboration with Boehringer Ingelheim to identify biomarkers for inflammatory bowel disease (IBD).

BiomX agreed to utilise its XMarker microbiome-based biomarker discovery platform for identifying biomarkers for a pathogenic bacterium associated with IBD.