AmpliPhi Biosciences’ Bacteriophage Cocktail Shown to Prevent C. difficile Biofilm Formation and Reduce Colonization

SAN DIEGO–(BUSINESS WIRE)–AmpliPhi Biosciences Corporation (NYSEMKT:APHB), 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 therapeutic and 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 now published online and is expected to be published in a hard copy special issue of Frontiers in Microbiology issue 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 larvalmodel, 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’ 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 bacterialinfections, 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 at http://journal.frontiersin.org/article/10.3389/fmicb.2016.01383/full.

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 at http://investor.ampliphibio.com/events-and-presentations.

About AmpliPhi Biosciences

AmpliPhi Biosciences Corporation (NYSEMKT:APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi’s product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and another Phase 1 clinical trial to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data for both trials before the end of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting P. aeruginosa and Clostridium difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.

About Bacteriophage

Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects.

About The University of Leicester

The University of Leicester is led by discovery and innovation – an international centre for excellence renowned for research, teaching and broadening access to higher education. The University of Leicester is ranked among the top one per cent of universities in the world by the THE World University Rankings. It is among the top 25 universities in the Times Higher Education REF Research Power rankings with 75% of research adjudged to be internationally excellent with wide-ranging impacts on society, health, culture, and the environment.

Find out more: https://le.ac.uk/about-us

Forward Looking Statements

Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the expected timing for commencing a Phase 1 clinical trial of AB-PA01, the expected timing for reporting data from AmpliPhi’s ongoing AB-SA01 trials, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.