TIDMOPTI
OptiBiotix Health PLC
18 January 2022
OptiBiotix Health plc
("OptiBiotix" or the "Company")
Publication of third human study on LP(LDL) (R)
OptiBi otix Health p lc (AI M : OPTI), a life sciences busi ness
d e vel o ping co m p o u n ds to tack le o besit y, high choleste
r ol, diabetes and skincare, a nn o unces that its wholly-owned
subsidiary, ProBiotix Health Ltd. ("ProBiotix"), has published a
third human volunteer study on its cholesterol reducing probiotic,
Lactobacilus plantarum ECGC13110402, branded as LP(LDL) (R).
Previous studies have shown that LP(LDL) (R) was safe and that
the higher the starting level of cholesterol, the greater the
cholesterol reduction. The aim of this study was to provide further
data in a different population group of hypercholesterolemic adults
(TC (3) 6mM). These subjects are most likely to benefit from a
cholesterol reducing effect and the target population of greatest
commercial interest group to partners exploring the potential of
LP(LDL) (R)as an over the counter (OTC) natural consumer health
product or drug biotherapeutic.
The study was a nine-week follow-up, single centre,
double-blind, randomised, placebo controlled human intervention
study. Participants were randomly assigned to one of two
treatments, active (4x10(9) CFU LP(LDL) (R) /day) or placebo.
Treatment duration was six weeks, focusing on the time points
whereby significant changes occurred in the original study,
followed by a three-week washout period.
The results showed that at six weeks, when volunteers taking
placebo were compared to those taking LP(LDL) (R), there were
statistically significant changes to clinically important
cardiovascular risk including a:-
-- 34.2% reduction in total cholesterol (p=0.001)
-- 28.4% reduction in LDL cholesterol (bad cholesterol) (p=0.03)
-- 17.6% reduction in non-HDL-C (p =0.001)
-- 28.6% reduction in apoB (p=0.008)
No safety, compliance, or tolerance issues were reported by
volunteers during the study. The results of this independent,
blinded study provide further evidence of the ability of LP(LDL)
(R)to improve clinically important cardiovascular risk factors in
volunteers with high levels of cholesterol. These results suggest
efficacy similar to many statins and treatments more typically
associated with pharmaceuticals and a potential use for LP(LDL)
(R)in:-
i. Individuals who have rising levels of cholesterol who have
been advised by their clinician to make lifestyle changes to reduce
their risk of coronary heart disease
ii. Individuals with raised levels of cholesterol who are statin
intolerant or do not want to take statins for ethical or other
medical reasons
iii. As a supplement to existing treatment which could allow a
clinician to use a lower, better tolerated statin dose
Stephen O'Hara, CEO of OptiBiotix, commented: "We are really
excited with the results of this study which
show statistically significant reductions in a number of
clinically important cardiovascular risk factors with no
compliance, tolerance, or safety issues. These results, along with
previous studies and customer feedback, suggest a potential role in
the use of probiotics like LP(LDL) (R) in individuals who have high
levels of cholesterol who are unwilling or unable to tolerate
existing treatments. Given the market opportunity and possible
limitations of existing treatments, the commercial potential for
LP(LDL) (R) in isolation or in combination with existing approaches
looks promising."
For further information, please contact:
OptiBiotix Health plc www.optibiotix.com
Stephen O'Hara, Chief Executive Contact via Walbrook
below
Cenkos Securities plc (Broker) Tel: 020 7397 8900
Callum Davidson / Neil McDonald
Michael Johnson / Russell Kerr (Sales)
Walbrook PR Ltd Mob: 07876 741 001
Anna Dunphy
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