OptiBiotix Health Regulatory News (OPTI)

11 November 2014

OptiBiotix Health plc

("OptiBiotix" or the "Company")

Contract signed with Reading University for start of clinical studies

OptiBiotix Health plc (AIM: OPTI), a life sciences business developing compounds to tackle obesity, high cholesterol and diabetes, announces that it has signed an agreement with the University of Reading for the commencement of human studies on its first product, a capsular food supplement to reduce cholesterol. This is in addition to the successful early studies on the Company's weight management formulation in yoghurts, announced at the end of October 2014.

The OptiBiotix product entering human trials will contain one or more of its patented cholesterol lowering Lactobacillus strains which have been shown to reduce cholesterol by between 71% and 82% in laboratory testing. The strains are currently undergoing preclinical studies to assess each strain's manufacturability, gastrointestinal robustness and activity against bile salts, to determine the best strain(s) to enter these human studies in January 2015. The data from the results of these studies will be available by the end of Q3 - 2015.

The study will involve identifying 50 subjects who have high cholesterol and its associated increased risk of cardiovascular disease ('CVD') but have had no treatment as yet. Half the subjects will be provided with a placebo, whilst the other half will be provided with Optibiotix's food supplement. Subjects will be advised not to change their regular diet or physical activity throughout the trial period and this will be confirmed with a food diary which will be analysed at the end of the trial. The treatment for each participant will last for approximately 12 weeks.

The study will be carried out by the Department of Food and Nutritional Sciences at the University of Reading, which is the largest department of its kind in the UK. Their Human Nutrition Unit has extensive experience in running human studies and has approximately 1,000 volunteer visits per year.

Stephen O'Hara, CEO of OptiBiotix, commented: "The signing of this contract completes another important milestone in product development as we build up the scientific evidence supporting the value of our products in the prevention and management of lifestyle diseases which cause significant global morbidity and mortality. High cholesterol levels are an established risk factor for cardiovascular disease which the World Health Organisation ('WHO') predicts will be a contributory factor in up to 40% of all human deaths by 2020. We hope that these human studies will help OptiBiotix establish the extent of the cholesterol lowering potential of its products, make a significant contribution to improving people's lives and build a valuable and sustainable business for shareholders."

About OptiBiotix- www.optibiotix.com

OptiBiotix was formed in March 2012 to develop compounds which modify the human microbiome - the collective genome of the microbes in the body - to prevent and manage human disease. 

The aim of OptiBiotix is to discover and develop microbial strains, compounds and formulations, which modulate the human microbiome and can be used as food ingredients and supplements or active compounds for the prevention and management of human metabolic diseases, examples of which include obesity, cholesterol and lipid distribution and diabetes. 

OptiBiotix has established a pipeline of microbiome modulators that can impact on lipid and cholesterol management, energy harvest and appetite suppression. The development pipeline is fuelled by its proprietary OptiScreen® and OptiBiotic® platform technologies designed to identify metabolic pathways and compounds that impact on human physiology and bring potential health benefits. These platforms are applicable across a wider range of other human diseases.