Phage therapy—bacteriophage and phage-derived products as anti-infective drugs

Abstract Novel therapeutic options are needed to halt the unabated spread of multiple-drug resistance. Phage-derived proteins, especially enzymes that can degrade the bacterial cell wall and cause cell-lysis, offer an attractive new paradigm for treating serious drug-resistant infections. Recent research and clinical data on this class of anti-infective agents have revealed their novel properties. This chapter describes the development path for phage-derived lysins, starting with discovery and leading to the strategy into the clinic, with P128, a novel chimeric antistaphylococcal lysin, as example. Standard regulatory pathways that apply to chemical antibiotics need to be modified to accommodate and accelerate the development of this class. The similarities and differences between these macromolecular bactericidal agents, and the traditional small molecule antibiotics are highlighted throughout this chapter. The data-intensive exemplification of research and development of lysin P128 in this write-up is aimed at influencing all the stakeholders, research community, clinicians, patients, biopharma industry, and regulators, into capitalizing the benefits that lysins offer.