AmpliPhi BioSciences Corporation, the leader in the development of bacteriophage-based antibacterial therapies to treat antibiotic resistant infections, has entered into collaboration and license agreements with UK-based University of Leicester to develop a novel bacteriophage therapy targeting Clostridium difficile (C. difficile), a serious gastrointestinal infection for which new treatments are urgently required.

Under the terms of the agreements, AmpliPhi will fund Dr Martha Clokie's team at the University of Leicester to progress non-clinical studies of bacteriophage products as an alternative to treating antibiotic resistant infections caused by C. difficile bacteria. Evaluations of the efficacy of bacteriophage therapy will be carried out at the University of Glasgow, UK, in the laboratory of Dr Gill Douce, under a three-way collaborative project between AmpliPhi, Leicester and Glasgow. C. difficile infection is widely accepted to be the leading cause of hospital-acquired (or nosocomial) infection-related morbidity and mortality, outpacing both antibiotic-resistant staphylococcus (MRSA) and enterococcus (VRE). Community-acquired cases also appear to be increasing in incidence. Figures released by the US Centre for Disease Control in its September 2013 report on antibiotic resistance, classed C. difficile as an urgent threat, causing 250,000 infections in the US every year and costing $1billion a year in excess medical costs.

The team at the University of Leicester has discovered phages that have been shown to be effective against clinically-relevant strains of C. difficile isolated from around the world. AmpliPhi will license the patents, materials and know-how related to these discoveries from the University of Leicester and, rights, title and interest to any future intellectual property developed under this collaboration will belong to AmpliPhi. Furthermore, AmpliPhi will have exclusive rights to certain background intellectual property of the University of Leicester, for which AmpliPhi will make milestone payments based on product development and pay royalties based on product sales.

Philip J Young, CEO of AmpliPhi said, "C. difficile causes at least 14,000 deaths a year in the US alone. We are very excited to be working with both the UK based teams to continue the development of innovative bacteriophage therapies. The progress has been impressive to date. We believe that this is the only phage based development program for this critical indication. Developing a treatment for C. difficile is in keeping with our global strategy to develop bacteriophage therapies for the rapidly escalating problem of antibiotic resistance."