Announcement PDF RNS Number : 8759A OptiBiotix Health PLC 02 October 2020 OptiBiotix Health plc ("OptiBiotix") FDA Investigational New Drug authorisation for product containing LPLDL® OptiBiotix Health plc (AIM: OPTI), a life sciences business developing compounds to tackle obesity, high cholesterol and diabetes notes that one of its partners, Seed Health ("Seed"), has received FDA authorisation for an Investigational New Drug ("IND") application for DS-01™, a broad spectrum multi-species, multi-strain probiotic which contains OptiBiotix's Lactobacillus plantarum LPLDL® (see https://www.prnewswire.com/news-releases/fda-authorizes-new-ind-to-evaluateimpact-of-multi-strain-probiotic-ds-01-on-gut-microbiota-of-patients-with-ibs301139955.html. The regulatory acceptance enables DS-01 to enter a Phase II randomised, tripleblind, and placebo-controlled clinical trial to investigate the role of the gut microbiome in patients with Irritable Bowel Syndrome ("IBS") and the impact of DS01™ on intestinal microbial communities. OptiBiotix previously announced (RNS: 22 May 2018) that it had entered into a nonexclusive agreement with Seed to produce, promote, market and commercialise products containing LPLDL® in the USA and the launch of Seeds Daily Synbiotic™ (RNS: June 7 2018) to consumers on its online platform www.seed.com. This FDA authorisation extends the opportunity into new drug and application areas for IBS. Stephen O'Hara, CEO of OptiBiotix, commented: "We are pleased to see that Seed has achieved FDA authorisation for an IND in a product containing OptiBiotix's Lactobacillus plantarum LPLDL®. OptiBiotix has whole genomic sequencing, built on a strong scientific and clinical evidence base, obtained FDA GRAS, and pharmaceutical GMP manufacture validation for LPLDL® which has created the potential for LPLDL® to be commercialised as a pharmaceutical drug product. Seed are one of a number of partners OptiBiotix is working with to bring a range of cardiovascular, general health, and IBS applications to supplement and pharmaceutical markets around the world." This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. OptiBiotix Health plc www.optibiotix.com Stephen O'Hara, Chief Executive Contact via Walbrook below Cairn Financial Advisers LLP (NOMAD) Liam Murray / Jo Turner / Ludovico Lazzaretti Tel: 020 7213 0880 finnCap (Broker) Geoff Nash/Kate Bannatyne (Corporate Finance) Tel: 020 7220 0500 Walbrook PR Ltd Anna Dunphy Tel: 020 7933 8780 or optibiotix@walbrookpr.com Mob: 07876 741 001 About OptiBiotix - www.optibiotix.com OptiBiotix Health plc (AIM: OPTI), which was formed in March 2012, brings science to the development of compounds which modify the human microbiome - the collective genome of the microbes in the body - in order to prevent and manage human disease and promote wellness. OptiBiotix has an extensive R&D programme working with leading academics in the development of microbial strains, compounds, and formulations which are used as active ingredients and supplements. More than twenty international food and healthcare supplement companies have signed agreements with OptiBiotix to incorporate their human microbiome modulators into a wide range of food products and drinks. OptiBiotix is also developing its own range of consumer supplements and health products. The current areas of focus for the business include obesity, cardiovascular health, and diabetes. This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com. RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy. END REAEAKEFEEPEFFA