BiomX Inc. (PHGE) said Monday that it has successfully dosed its first patient as part of its phase 2b trial evaluating BX004 for the treatment of cystic fibrosis patients with chronic pulmonary infections caused by Pseudomonas aeruginosa infections.
Topline results from the study are expected in Q1 2026, the company said.
In the second half of 2025, BiomX anticipates feedback from the FDA regarding its plans on the analyses of real-world evidence to link bacterial reduction to clinical outcomes. Regulatory alignment on a microbiological endpoint would streamline the approval pathway and provide a means of addressing these patients, the company said.
The phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating BX004 in approximately 60 cystic fibrosis patients with chronic Pseudomonas aeruginosa bacterial infections.
Cystic fibrosis is a genetic disorder that impairs the normal clearance of mucus from the lungs, which facilitates the infection of the lungs by bacteria.
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