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FDA Investigational New Drug authorisation
FDA Investigational New Drug authorisation.
About this update from Optibiotix Health Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8759A\n OptiBiotix Health PLC\n 02 October 2020\n \n \n \n OptiBiotix Health plc\n \n \n (\n \n \"OptiBiotix\")\n \n \n \n \n FDA\n \n \n Investigational New Drug \n \n \n authorisation for product containing \n \n LPLDL®\n \n \n \n OptiBiotix Health plc (AIM: OPTI), a life sciences business developing compounds to tackle obesity, high\n \n \n cholesterol and diabetes notes that one of its partners, Seed Health (\"Seed\"), has received FDA authorisation for an \n 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.\n \n \n 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.\n \n \n \n \n \n OptiBiot\n ix previously announced (RNS: 22 \n 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.\n \n \n \n S\n \n tephen O'Hara, CEO of OptiBiotix, commented: \n \n \"We are pleased to see that Seed has achieved \n \n FDA authorisation for an IND in a product containing OptiBiotix's Lactobacillus plantarum \n LPLDL®.\n \n OptiBiotix has whole genomic sequencing, built on a strong scientific and clinical evidence base, obtained FDA GRAS, and pharmaceutical GMP manufacture validation for\n 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 ...