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Publication of third human study on LPLDL®
18 January 2022
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 LPLDL®.
Previous studies have shown that LPLDL® 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 LPLDL®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 (4x109CFU LPLDL® /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 LPLDL®, 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 LPLDL®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 LPLDL®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 LPLDL® 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 LPLDL® in isolation or in combination with existing approaches looks promising."
For further information, please contact:
OptiBiotix Health plc
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
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'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', "expect", ''will'' or the negative of those, variations or comparable expressions, 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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