A Bacteriophage Cocktail Created by AmpliPhi Biosciences® is Shown to Prevent C. difficile Biofilm Formation and Reduce Colonization

AmpliPhi Biosciences Corporation^®, a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, announced the publication of data from a preclinical study conducted by its collaborators at the University of Leicester demonstrating the prophylactic efficacy of AmpliPhi's proprietary phage cocktail, in vitro and in vivo, for the treatment and prevention of Clostridium difficile (C. difficile) infections. The paper is published online and is expected to be published in a hard copy special issue of Frontiers in Microbiology dedicated to the past, present and future of phage research and development.

University of Leicester researchers Janet Nale, Ph.D., and Prof. Martha Clokie, demonstrated in vitro that C. difficile phages are effective pre-biofilm therapeutics and can penetrate established biofilms. In a larval model, these phages reduced C. difficile bacterial counts when administered prophylactically. Furthermore, combinations of phages and vancomycin led to a marked decrease in C. difficile colonization.

The data support our phage cocktails products' great potential as effective therapies to treat antibiotic resistant and difficult to treat infections, including C. difficile, said M. Scott Salka, CEO of AmpliPhi Biosciences. "I would like to commend Dr. Nale and Prof. Clokie for their exciting and insightful research demonstrating the immense promise of phage therapeutics. Their findings underscore our enthusiasm for the potential of our proprietary platform to enable the development of therapeutics to treat a broad range of bacterial infections that are resistant or have suboptimal responses to current antibiotic therapies.”

Prof. Clokie added: “The results suggest that it may be possible to reduce the threat of C. difficile, and potentially other bacterial infections, through the use of phage both prophylactically to prevent infection, and therapeutically once an infection is established. Phage therapy targets specific pathogenic bacterial populations while sparing the beneficial microbiome.”

The paper, titled “‘Get in Early’; Biofilm and Wax Moth (Galleria mellonella) Models Reveal New Insights into the Therapeutic Potential of Clostridium difficile Bacteriophages” can be found in the Frontiers of Microbiology journal.

Preliminary data from this study were recently presented at the Viruses of Microbes 2016 Conference held in Liverpool, UK, in a poster titled ‘Phages as Potential Prophylactic Therapeutics for Clostridium difficile Infection’, which was presented by Prof. Clokie and Dr. Nale. At the same conference, AmpliPhi’s senior scientist Susan Lehman, Ph.D., presented a poster titled ‘Bacteriophage Therapy for the Treatment of P. aeruginosa Infections in Cystic Fibrosis Patients’, which described the in vitro and in vivo activity of AmpliPhi’s proprietary, investigational phage cocktail AB-PA01. Results showed that AB-PA01 is active in vitro against 87.2% of the 429 clinical isolates tested, including multi-drug resistant as well as sensitive strains of Pseudomonas aeruginosa. The cocktail also survived nebulization with minimal titer loss using five different delivery devices, demonstrating that multiple effective and patient-friendly options are available to pair with the cocktail. Both posters are available on AmpliPhi’s website.