OptiBiotix Health PLC LPLDL® determined GRAS by an Expert Panel in US (6638Q)
21 February 2019 - 6:00PM
UK Regulatory
TIDMOPTI
RNS Number : 6638Q
OptiBiotix Health PLC
21 February 2019
OptiBiotix Health plc
("OptiBiotix" or the "Company")
LP(LDL) (R) determined GRAS by an Expert Panel in the United
States
OptiBiotix Health plc (AIM: OPTI), a life sciences business
developing compounds to tackle obesity, cardiovascular disease and
diabetes, announces that ProBiotix Health Ltd, its fully-owned
subsidiary, has had its cholesterol and blood pressure reducing
Lactobacillus plantarum LP(LDL) (R) probiotic strain determined as
Generally Recognized As Safe ("GRAS") by an independent Expert GRAS
Panel in the United States.
GRAS is a United States Food and Drug Administration (FDA)
designation that any substance added to food is considered safe by
experts. GRAS status is therefore required for the use of these
substances in foods. In the case of probiotics, it is a
strain-specific process in which all strains not described before
1958 - as is the case of LP(LDL) (R) - must be categorised as GRAS
if they are to be added to foods. GRAS assessment involves
submitting an extensive technical dossier for evaluation by an
independent panel of experts. They confirm if the ingredient is
safe, under what conditions it can be used, and for which
applications.
The Expert GRAS Panel that reviewed the LP(LDL) (R) dossier was
formed by international experts in toxicology, pharmacology and
regulatory affairs. After evaluating information on LP(LDL) (R)'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
LP(LDL) (R) is safe for use in food and beverage categories at a
concentration of up to 10 billion colony forming units (CFU) per
serving. This is more than double the dose found to significantly
reduce cholesterol and blood pressure in the human trial conducted
by Reading University (Costabile et al., 2017).
The process of GRAS determination has taken over two years of
work, led by OptiBiotix's Business Development Director, Dr. Luis
Gosalbez. Compiling the GRAS dossier has involved the generation of
large amounts of laboratory data, genetic analyses, and an
extensive review of the scientific literature. Whilst a costly and
time-consuming process, it extends the potential applications of
LP(LDL) (R) to use as a functional ingredient in food, dairy, and
beverage products across the USA.
This is a strategic step by OptiBiotix to extend the market
opportunity within the US probiotic market to food, dairy, and
beverage products. The USA is one of the largest and fastest
growing probiotic markets in the world with sales in 2016 of
supplements accounting for $2.06 billion, and food and beverage
products $5bn per annum*.
(*Market data from 'TRENDS, INNOVATIONS AND OPPORTUNITIES
DRIVING THE GLOBAL PROBIOTICS MARKET' (Euromonitor International
June 2017)
Stephen O'Hara, CEO of OptiBiotix, commented: "We are pleased to
announce that the independent Expert Panel has ruled in favour of
LP(LDL) (R)'s GRAS status. This is a significant achievement and a
major commercial milestone as it expands the potential applications
of LP(LDL) (R) 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 USA. In addition, obtaining
GRAS status is 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, is a major point of
differentiation from other probiotics, as very few strains
currently have this status.
This acknowledgement provides international, independent
endorsement from experts for the science behind LP(LDL) (R) and for
OptiBiotix's approach to novel probiotic strain development."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
For further information, please contact:
OptiBiotix Health plc www.optibiotix.com
Stephen O'Hara, Chief Executive Contact via Walbrook
below
Cairn Financial Advisers LLP (NOMAD)
Liam Murray / Jo Turner Tel: 020 7213 0880
finnCap (Broker)
Geoff Nash/ Scott Mathieson / Kate Bannatyne
(Corporate Finance) Tel: 020 7220 0500
Camille Gochez (Corporate Broking)
Walbrook PR Ltd Tel: 020 7933 8780 or optibiotix@walbrookpr.com
Anna Dunphy Mob: 07876 741 001
About OptiBiotix - www.optibiotix.com
OptiBiotix Health plc (AIM: OPTI), which was formed in March
2012, brings science to the development of compounds which modify
the human microbiome - the collective genome of the microbes in the
body - in order to prevent and manage human disease and promote
wellness.
OptiBiotix has an extensive R&D program working with leading
academics in the development of microbial strains, compounds, and
formulations which are used as active ingredients and supplements.
More than twenty international food and healthcare supplement
companies have signed agreements with OptiBiotix to incorporate
their human microbiome modulators into a wide range of food
products and drinks.
OptiBiotix is also developing its own range of consumer
supplements and health products. The Company's current areas of
focus include obesity, cardiovascular health, and diabetes.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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