Physicochemical characterization of pre-clinical samples of a bacteriophage therapy spray-on patch for the treatment of COVID-19-related pressure injury resistant infections

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The cororonavirus pandemic has brought pressure injuries into sharp focus. The incidence of pressure injuries has dramatically risen amongst patients and health professionals alike. This is due by the global increase in ICU admissions, considerable rise in the need of mechanical ventilation, increased use of prone positioning to treat acute respiratory distress syndrome, and sharp increase in the use of personal protective equipment and medical devices. Pressure injuries susceptible to opportunistic multi-drug resistant infections (MDR) can result in delayed treatment, septicemia, osteomyelitis, amputation, and death. Failure and reduced efficacy of antibiotic treatment are frequently reported for MDR strains for infections located in areas of limited vascularization in COVID-19 patients. An alternative or supplement to antibiotic therapy is the use of bacteriophages to target bacterial infections. Administration of phages in humans requires an appropriate delivery system. The production of stable, non-toxic spray under physiological conditions constitutes a novel approach for the safe translation of bacteriophages to the clinic. To this end we encapsulated the bacteriophage cocktail in amino acid-based biodegradable polymers for a prolonged delivery of phages at the site of injury. A pre-IND meeting was held with the FDA in 2020 to establish a comprehensive CMC and clinical program for Phagelux product PL-03-BM. In this collaborative research project, we aim to characterize engineering and preclinical batches of microencapsulated phages in order to clarify issues related to CMC and further the overall drug development program PL-03-BM for the treatment and prevention of pressure ulcer wound infections.