OptiBiotix up as LPLDL gets 'safe' status in US
By Josh White
Date: Thursday 21 Feb 2019
(Sharecast News) - Life sciences firm OptiBiotix Health confirmed on Thursday that its wholly-owned subsidiary ProBiotix Health has had its cholesterol and blood pressure reducing 'Lactobacillus plantarum LPLDL' probiotic strain determined as 'Generally Recognized As Safe' (GRAS) by an independent expert GRAS panel in the United States.
The AIM-traded firm described GRAS as a United States Food and Drug Administration (FDA) designation that any substance added to food was considered safe by experts.
GRAS status was therefore required for the use of such substances in foods.
In the case of probiotics, it was a strain-specific process in which all strains not described before 1958 - as is the case of LPLDL - must be categorised as GRAS if they are to be added to foods.
GRAS assessment involved submitting an extensive technical dossier for evaluation by an independent panel of experts, who confirmed if the ingredient is safe, under what conditions it could be used, and for which applications.
OptiBiotix said the expert GRAS Panel that reviewed the LPLDL dossier was formed by experts in toxicology, pharmacology and regulatory affairs.
It explained that. after evaluating information on LPLDL's science, genetic composition, lack of antibiotic resistance, human clinical study results and market feedback, the panel members concluded that the evidence was sufficient to determine that LPLDL was safe for use in food and beverage categories at a concentration of up to 10 billion colony forming units (CFU) per serving.
That was more than double the dose found to "significantly reduce" cholesterol and blood pressure in the human trial conducted by Reading University.
The process of GRAS determination had taken more than two years of work, and was led by OptiBiotix's business development director Dr Luis Gosalbez.
Compiling the GRAS dossier involved the generation of "large amounts" of laboratory data, genetic analyses, and an "extensive review" of the scientific literature, the company said.
It added that while it was a costly and time-consuming process, it extended the potential applications of LPLDL to use as a functional ingredient in food, dairy, and beverage products across the US.
The board said it was a strategic step by OptiBiotix to extend the market opportunity within the US probiotic market to food, dairy, and beverage products.
It explained that the US was one of the largest and fastest growing probiotic markets in the world, with sales of supplements in 2016 accounting for $2.06bn, and food and beverage products reaching $5bn per annum/
"We are pleased to announce that the independent expert panel has ruled in favour of LPLDL's GRAS status," said OptiBiotix chief executive officer Stephen O'Hara/
"This is a significant achievement and a major commercial milestone as it expands the potential applications of LPLDL from use as a supplement to use as a functional ingredient in a wide range of food, dairy, beverage, and high value medical food applications, across the US."
In addition, O'Hara said obtaining GRAS status ws increasingly being seen by large US corporates as a "key requirement" to independently validate the safety of commercial probiotic strains in supplements. and as such, was a major point of differentiation from other probiotics, as very few strains currently had the status.
"This acknowledgement provides international, independent endorsement from experts for the science behind LPLDL and for OptiBiotix's approach to novel probiotic strain development."
As at 1540 GMT, shares in OptiBiotix Health were up 0.46% at 86.9p.
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