Description:
<jats:title>Abstract</jats:title>
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<jats:title>Background</jats:title>
<jats:p>Diabetic Foot Ulcers (DFU) are a major complication in patients with diabetes and affect globally 170 million patients. Approximately 28% of patients with infected DFU require amputation. Diabetic foot infections (DFI) caused by persistent or multidrug resistant organisms are a threat to the outcome of therapy. Infections are mostly polymicrobial, and major pathogens include Staphylococcus aureus and Pseudomonas aeruginosa. A promising new approach using phages may potentially be a novel modality to increase treatment success. TP-102 is an innovative bacteriophage cocktail for treatment of DFI, a diabetes related unmet need.</jats:p>
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<jats:title>Methods</jats:title>
<jats:p>TP-102 comprised of 5 different phages, targeting S. aureus, P. aeruginosa and Acinetobacter baumannii. This study is a Phase I/II clinical trial performed in Israel looking at safety and tolerability. TP-102 bacteriophage cocktail was applied topically at a titer of 109 PFU/mL/cm3 of target ulcer. Two cohorts receive multiple doses of TP-102. In non-infected DFU (cohort 1) for 1 week and for 28 days in DFU with infection grade 2 or 3 (PEDIS classification, cohort 2). Treatment groups were TP-102 with standard of care versus placebo and standard of care. Outcomes include microbiologic data on the 3 target bacteria, ulcer healing characteristics, incidence and severity of TP-102-emergent solicited local and systemic adverse events, and their relationship to the treatment, from the first application of TP-102 until the end of study.</jats:p>
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<jats:title>Results</jats:title>
<jats:p>For the evaluation of safety in patients with non-infected ulcers, eight patients were enrolled to the first cohort. Six were treated with TP-102 and 2 with placebo. TP-102-treated patients had no severe adverse events associated with the treatment. In the second cohort a total of 18 patients are currently being treated with TP-102 or placebo for 28 days, three times a week. Recruitment is ongoing and results of the trial will be presented.</jats:p>
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<jats:title>Conclusion</jats:title>
<jats:p>TP-102 appeared to be safe when applied to patients with uninfected diabetic foot ulcers. The treatment is a potential new non-traditional antimicrobial for topical application. The efficacy of TP-102 in the treatment of infected diabetic ulcers is being assessed in an ongoing randomized clinical trial.</jats:p>
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<jats:title>Disclosures</jats:title>
<jats:p>Ran Nir-Paz, MD, BiomX: Advisor/Consultant|Technophage: Advisor/Consultant Clara Leandro, PhD, Technophage: Employee Raquel Barbosa, PhD, Technophage: Employee Helena Dordio, PhD, Technophage S.A.: Employee Miguel Garcia, n/a, IBV Innovation Bioventures Lda: Board Member|IBV Innovation Bioventures Lda: Ownership Interest|LX Bio Pharmaceuticals SA: Board Member|LX Bio Pharmaceuticals SA: Ownership Interest|TechnoPhage, SA: Board Member|TechnoPhage, SA: Author of several patent applications|TechnoPhage, SA: Ownership Interest.</jats:p>
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