Clinical and Regulatory Development of Antibiofilm Drugs: The Need, the Potential, and the Challenges

Abstract

Escalating rates of mortality and morbidity associated with chronic, recurrent, persistent, and increasingly antibiotic-resistant bacterial infections have generated an extremely urgent unmet need for new antibiotics, particularly those with new mechanisms and targets of action. Over 80 % of all infections are associated with biofilms, a growth condition that not only increases their resistance to currently available antibiotics but also enhances their capability for evading many host defenses. Targeting biofilms may therefore be one of the most important new strategies available for the development of novel antibacterials. In spite of this, biofilms remain underappreciated as targets by the current global healthcare system. Deterrents to their clinical development are primarily associated with the antimicrobial regulatory approval process and insufficient financial incentives offered to pharmaceutical developers—issues which are just now becoming recognized by governments and professional health associations around the world. To facilitate the development of antibiofilm drugs, it is critical that infectious disease stakeholders engage in an ongoing dialog with regulatory agencies to develop standardized methods with respect to (a) the rapid, effective diagnostic assessment of biofilm-related infections and (b) the clinical assessment of antibiofilm drug efficacy. It is also imperative that regulatory agencies are willing to exercise maximum flexibility in approving these innovative and much needed new drugs.