Preclinical data and safety assessment of phage therapy in humans

Bacteriophages (phages) are natural biological entities that kill bacteria with species specific precision, rendering them attractive for therapeutic purposes. Phages were discovered over a century ago, but, after antibiotic discovery, their use as antimicrobials dwindled. Interest in phage therapy has, however, been rekindled by increasing multi-drug resistance to routine and frontline antibiotics and by the slowing of antibiotic innovations. To build on fundamental phage research studies and compassionate usage, information on safety and efficacy of phages is needed to motivate clinical trials and are necessary for phage therapy to become mainstream. In this review, we discussed essential phage characterisation parameters alongside the merits and limitations of state-of-the-art models to gather preclinical data on the safety and efficacy of phage therapeutics.