Bacteriophages (phages) are viruses that specifically kill bacteria and can be found everywhere in the environment. As drug-resistant infections continue to rise and there is a lack of new antibiotics being developed, new strategies are needed to counter this growing threat to human health. Military personnel are exposed to infectious diseases when they are deployed and frequently suffer from severe infections in traumatic wounds with bacteria that are not treatable with available antibiotics. Many times the only solution to care for these wounds is amputation of injured limbs.

Because both military and civilian populations face a serious risk of untreatable bacterial infections, treatment with phages has been explored due to their ability to specifically kill bacteria including those resistant to antibiotics. Many countries of the former Soviet Union continue to use phage therapy today, but phage-based products are not currently approved by the U.S. Food and Drug Administration (FDA) due to limited published findings on safety and treatment effectiveness in human infections. The U.S. Army and Navy infectious diseases research teams are currently working together to develop phage as for therapeutic use in military personnel. This focused program proposal is applying to the Topic Area of Antimicrobial Resistance. It is designed to advance several complementary phage products through the early stages of development as well as animal safety and efficacy trials. These will serve as the foundation for therapeutic use in human studies and more robust clinical trials advancing toward FDA approval. To achieve this, we will harvest phages from environmental locations around the globe and fully characterize the newly isolated phages for inclusion into a robust phage bank that will feed our product development strategies. We will develop phage products using three complementary strategies: (1) fixed (meaning the composition of the phage mix does not change) cocktails of naturally isolated phages, (2) customizable (meaning the composition of the phage mix changes on a case-by-case basis depending on the bacteria causing the infection) cocktails of naturally isolated phages, and (3) materials with integrated phage cocktails for active delivery into wounds to prevent and treat infections in both the field and clinical settings.

By the end of the performance period, we aim to have multiple phage products in development, with data to support advancement to human clinical trials. Once finally approved by the FDA, these phage products will be available to treat infections in both military and civilian hospitals. We will also seek to develop strategies to use phage for field care of combat wounds to improve clinical outcomes in injured military personnel.