RCS - OptiBiotix Health - Publication of third human study on LPLDL

OptiBiotix HealthAnnouncement

18/01/2022 07:05

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RNS Number : 7311Y  OptiBiotix Health PLC  18 January 2022

OptiBiotix Health plc

("OptiBiotix" or the "Company")

 

Publication of third human study on LP(LDL)®

 

OptiBiotix Health plc (AIM:
OPTI), a life sciences business developing compounds to tackle obesity, high
cholesterol, diabetes and skincare, announces 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)®.

 

Previous studies have shown that LP(LDL)® 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 (TC³6mM).  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)®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)® /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)®, 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)®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)®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)® 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)® in isolation or in
combination with existing approaches looks promising."

 

 

For further information, please contact:

 

 OptiBiotix Health plc                                  www.optibiotix.com (http://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

 

 

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward
looking statements. Forward looking statements are identified by their use of
terms and phrases such as ''believe'', ''could'', "should" ''envisage'',
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including references to assumptions. These forward looking statements are not
based on historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of operations,
performance, future capital and other expenditures (including the amount,
nature and sources of funding thereof), competitive advantages, business
prospects and opportunities. Such forward looking statements reflect the
Directors' current beliefs and assumptions and are based on information
currently available to the Directors.

 

 

 

 

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