Impact of Streptococcus thermophilus FX856, a live biotherapeutic product, on inflammatory markers and gastrointestinal symptoms in an obese population

There is a lack of satisfactory treatments for inflammatory bowel disease (IBD), an excruciatingly debilitating condition which affects 1 in 123 people in the UK (\>0.5 million) and 6.8 million worldwide. Current treatments have significant negative side effects, affecting quality of life of patients and reducing compliance, leading to exacerbation of symptoms. Probiotics are popular 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 gut and immune system to reduce inflammation. To do this, we propose to conduct a trial of FX856 in obese individuals, who are likely to have chronic mild gut inflammation, and examine markers of inflammation in their blood and faeces. Data generated in this study will demonstrate pharmacological activity of FX856 which justifies commercial development and will form a key part of our Clinical Trials Application, the documentation required to conduct a clinical trial of a new medicinal product.