LONDON (ShareCast) - (Sharecast News) - Life sciences company OptiBiotix Health announced on Friday that one of its partners, Seed Health, has received US Food and Drug Administration authorisation for an investigational new drug (IND) application for 'DS-01'.
The AIM-traded firm described DS-01 as a broad spectrum multi-species, multi-strain probiotic, which contains OptiBiotix's Lactobacillus plantarum 'LPLDL'.

It said the regulatory acceptance would enable DS-01 to enter a phase 2 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.

OptiBiotix previously announced in May 2018 that it had entered into a non-exclusive agreement with Seed to produce, promote, market and commercialise products containing LPLDL in the US, and the launch of Seed's 'Daily Synbiotic' to consumers.

It said the FDA authorisation extended the opportunity into new drug and application areas for IBS.

"We are pleased to see that Seed has achieved FDA authorisation for an IND in a product containing OptiBiotix's Lactobacillus plantarum LPLDL," said chief executive officer Stephen O'Hara.

"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 is 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."

At 1011 BST, shares in OptiBiotix Health were up 7.71% at 59.24p.

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