A drug development firm has been given the green light to take into human trials a treatment for irritable bowel syndrome (IBS) that contains OptiBiotix Health PLC's (LON:OPTI) Lactobacillus Plantarum LPLDL probiotic.
The company said Seed Health’s investigational new drug application has been approved by the US Food & Drug Administration, which will allow DS-01 to go straight into phase II clinical trials.
The OptiBiotix release states this will be a triple-blind, and placebo-controlled study to assess the role of the gut microbiome in patients with IBS and the impact of the drug candidate on intestinal microbial communities.
"We are pleased to see that Seed has achieved FDA authorisation for an IND in a product containing OptiBiotix's lactobacillus plantarum,” said chief executive Stephen O'Hara.
He pointed out that the wealth of bedrock of data, including genomic sequencing, FDA ‘generally recognised as safe’ sign-off and good manufacturing practice accreditation for LPLDL “created the potential for it to become a 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,” he added.