2nd Oct 2020 11:13
(Alliance News) - Life sciences company OptiBiotix Health PLC on Friday noted that partner Seed Health Inc has received approval from the US Food & Drug Administration for an investigational new drug application for DS-01.
DS-01 is a broad spectrum multi-species, multi-strain probiotic which contains OptiBiotix's lactobacillus plantarum, a probiotic that aids elements of cardiovascular and wellbeing.
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 and the impact of DS-01 on intestinal microbial communities.
Chief Executive Stephen O'Hara said: "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 generally recognised as safe, and pharmaceutical good manufacturing practices manufacture validation for LPLDL which has created the potential for LPLDL to be commercialised as a pharmaceutical drug product."
OptiBiotix shares were up 3.6% at 57.00 pence each in London on Friday morning.
By Greg Roxburgh; [email protected]
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