Fig. 6: Phase 1b/2a clinical trial.

A–D Subjects receiving BX004-A are marked in blue, whereas subjects receiving placebo are marked in orange. Semi-transparent curves represent individual patients, whereas bold lines represent mean ± SE of the group. On day 3, there were two collection timepoints, marked 3a and 3b. Seven patients received BX004-A whereas two patients received placebo. Treatment duration (days 1–8) is indicated by gray shading. A Schematic illustration of the trial design is given above the panel (QD: daily; BID: twice daily), followed by a pharmacokinetics curve. Y-axis values of zero represent no detectable phages in sample. B Pharmacodynamic curves depicting change in P. aeruginosa sputum density over the course of treatment. Y-axis values of zero represent no change in CFU compared to baseline. The p-values (two-sided t-test) are day2:9e-4, day3a:0.045, day3b:0.780, day4:0.035, day8:0.486, day15:0.029. An earlier version of this pharmacodynamic analysis is presented in Table S8. C Relative abundance of P. aeruginosa within the sputum microbiome over time, as measured by 16S rRNA sequencing. The P-values (two-sided t-test) are day1:0.657, day8:0.411, day15:0.207. D Shannon diversity index of sputum microbiome over time, as measured by 16S rRNA sequencing. The p-values (two-sided t-test) are day1:0.940, day8:0.361, day15:0.121. Source data are provided as a Source Data file.