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 (4x10⁹CFU 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."

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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.