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-evaluate-impact-of-multi-strain-probiotic-ds-01-on-gut-microbiota-of-patients-with-ibs-301139955.html.
The regulatory acceptance enables DS-01 to enter a Phase II randomised, triple-blind, and placebo-controlled clinical trial to investigate the role of the gut microbiome in patients with Irritable Bowel Syndrome (“IBS”) and the impact of DS-01™on intestinal microbial communities.
OptiBiot ix previously announced (RNS: 22 May 2018) that it had entered into a non-exclusive 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.
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.
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