10111751Evaluation of the interactions of a novel live biotherapeutic product for the treatment of gut inflammation with the GI tract in an in vitro modelClosedCollaborative R&DInnovate UKThere is a lack of satisfactory treatments for inflammatory bowel disease (IBD), an excruciating, debilitating condition which affects 1 in 123 people in the UK (\\\>0.5 million) and 6.8 million worldwide. Currently available treatments have significant negative side effects, affecting quality of life of patients and reducing compliance, leading to exacerbation of symptoms. Probiotics are popular supplements due to their perception as safe, natural treatments, but currently marketed products cannot function during active disease. Live biotherapeutic products (LBPs) are an emerging class of therapeutics based on probiotics which can prevent, treat or cure a disease or condition. Ferryx develops LBPs which are functional during active inflammation, an area where conventional probiotics fail. During active inflammation or stress, gut iron levels increase. Most resident gut bacteria can grow under high iron conditions, but conventional probiotics cannot; they are rapidly outcompeted and cannot have a beneficial effect. Ferryx selects LBPs which thrive under both healthy and high iron conditions and thus function during active disease. Our lead product is FX856, a type of bacteria called _Streptococcus thermophilus_. This is the first LBP to be developed which has been specifically chosen for its ability to survive and thrive during active inflammation or stress. Our ultimate goal is to develop FX856 as a prescription medicine for the treatment of IBD. Our preclinical work has shown that this product has anti-inflammatory properties and potential to induce healing in the gut. FX856 has an excellent safety profile and has been designated Generally Regarded as Safe (GRAS) by the FDA, meaning we are able to start clinical trials in patients with IBD rather than healthy volunteers. Before we start a clinical trial, we need to understand more about how FX856 interacts with the gastrointestinal tract, such as how it interacts with mucus and the cells that line the gut, how it affects the immune system, and how does it change the composition of the microbiome? To do this, we will use an _in vitro_ gut model to allow us to evaluate these parameters. Data generated during this feasibility study will demonstrate pharmacological activity of FX856 which justifies commercial development. This data will allow rapid development of FX856 by informing a subsequent grant application to evaluate impact of different doses of FX856 on gut microbiota activity and composition in a simulated actively inflamed gut using faecal matter from IBD patients prior to a clinical trial.