A Phase 2b Clinical Study to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients with Diabetic Foot Infection

Diabetic foot ulcers infected by Acinetobacter baumannii, Pseudomonas aeruginosa and /or Staphylococcus aureus

Number and percentage of Treatment Emergent Adverse Events (TEAEs) [Day 1 (Baseline) to EOT];, Statistically significant change in the percentage of patients in the respective IWGDF/IDSA classes for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];, Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].

Change in mean CRP/ESR/PCT/WBC count value for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];, Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WBC count for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];, Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo, in addition to SoC, at EOT;, Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo, in addition to SoC, at EOT;, Changes in wound size, depth, granulation and partial closure (25%, 50%, 75%)from baseline, for TP-102 versus Placebo, in addition to SoC [Day 3, 8, 15, EOT and EOS]., Percentage of patients that achieve wound healing (complete wound closure) by EOS for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to FUP2]., Total Area Under the Curve (AUC) of the mean DFUWI score for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].

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