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Cardiovascular disease remains the world’s number one killer, with most people at risk prescribed statins and aspirin. This research is therefore a significant step forward for a probiotic that can truly make a difference.
Dr Adele Costabile, lead researcher on the study and Reader of Nutrition in our School of Health and Life Sciences added “it is a very promising study in the fight against cardiovascular disease with the probiotic Lactobacillus plantarum LPLDL.”
This research is part of an ongoing research project funded by OptiBiotix Health Plc.
Stephen O’Hara, CEO at OptiBiotix, commented: “The results of this study are remarkable and firmly establish LPLDL® as the probiotic for heart health. Our previous human intervention studies have highlighted LPLDL® as an excellent candidate to reduce cholesterol across different patient groups and countries. Now, with the statistically significant results of our latest study, both partners and consumers can rest assured they are using a science-backed probiotic that not only reduces total cholesterol, but multiple risk factors associated with CHD.
“For the industry, this is a significant step forward for a probiotic that can truly make a difference, demonstrating that LPLDL® champions scientific evidence to deliver impressive results.”
Are you talking about Seed Health elric, if so their DS01 product contains not just LPLDL but also all these other ingredients so as a clinical trial is probably irrelevant to LPLDL?
Digestive Health / Gut Immunity / Gut Barrier Integrity Probiotic Blend 37.0 Billion AFU Bifidobacterium longum SD-BB536-JP
Bifidobacterium breve SD-BR3-IT
Lactiplantibacillus plantarum SD-LP1-IT
Lacticaseibacillus rhamnosus SD-LR6-IT
Lacticaseibacillus rhamnosus HRVD113-US
Bifidobacterium infantis SD-M63-JP
Bifidobacterium lactis SD-BS5-IT
Bifidobacterium lactis HRVD524-US
Lactobacillus crispatus SD-LCR01-IT
Lacticaseibacillus casei HRVD300-US
Bifidobacterium breve HRVD521-US
Bifidobacterium longum HRVD90b-US
Bifidobacterium lactis SD150-BE
Limosilactobacillus fermentum SD-LF8-IT
Lacticaseibacillus rhamnosus SD-GG-BE
Limosilactobacillus reuteri RD830-FR
The real benefit from the study was outlined in the 5th Aug 2021 RNS: " The publication of a placebo-controlled human study which shows that LPLDL® can achieve similar reductions in total cholesterol and LDL (bad cholesterol) to statins, with no reported side effects. This has been with the editorial board of a peer reviewed journal for a number of months. COVID publications are currently being prioritised by editors but we expect this to be published in H2. Publications on how a product works, its safety and efficacy, are important to pharmaceutical partners who may wish to sell LPLDL® as a drug, or Over the Counter (OTC) in high value hospital, GP, and pharmacy channels."
It sounds like a half way house. If they'd already passed the saftey and eficacy end points required for clinical trials in the past why run more? Certainly the results demonstrate the route should be pursued and whatever hoops need to be jumped through to go for regulatory approval would be worth doing.
Skid, we need to stick to the facts indeed. LPLDL is not a new product, and it is not a drug (it is a food supplement), so it would not be subject to a multi phase clinical trial as you suggest. It has already passed all the requisite safetly, tolerability and efficacy trials that would be typical of a phase 1 and 2 study some years ago. So yes, these results can be regarded as a proper clinical trial. The company has also indicated from previous releases that it is also exploring moving LPLDL along the pharmaceutical route in addition to over the counter.
Ski, from the March Commercial and Strategic Update the study is considered the equivalent to a stage II pharma study
"LPLDL® drug biotherapeutic: The Company has employed Christopher Nother on a part time consultancy basis to explore the use of LPLDL® in pharma, either as an 'over the counter' (OTC) product, or a drug biotherapeutic in markets outside the USA. LPLDL® has already received an investigational New Drug Approval with Seed Health for a Phase II pharma clinical study. The Company will shortly be publishing placebo controlled human studies which show LPLDL® can achieve similar reductions in total cholesterol and LDL (bad cholesterol) to statins, without any side effects. Early discussions suggest that ProBiotix's existing humans studies provide safety, tolerance, and efficacy comparable to that typically seen in a Phase II pharma study. If this is confirmed the risk, timeline, and costs to develop LPLDL® as a drug biotherapeutic is substantially reduced. Chris is currently assessing the costs and timelines to develop LPLDL® as a drug biotherapeutic and the potential to create a biotherapeutic drug division or separate Limited company to fully exploit the opportunity and potential for significant upside."
Larus, I'm a fan here but we need to stick to facts. This is not a medical trial in the sense most people would see it similar to a multi million £ drug test through various phases of development. I'm not in the industry so don't know how the medical "establishment" view these studies, and then what the next step is to get these either prescribed or bought - any thoughts from investors better qualified than myself (basically all of you) very welcome.
No-one from the company is saying ditch the statins, but there is a large number of people with high cholesterol who are unable or unwilling to take statins long term for which LPLDL would be an ideal alternative https://scopeblog.stanford.edu/2019/02/14/failure-to-take-statins-leads-to-higher-mortality/ "A lot of patients with arteries clogged by cholesterol aren’t taking their statins, Stanford researchers have found. That boosts their risk of death, according to a new study.
More than a third of patients with cardiovascular disease who have been prescribed statins to reduce cholesterol failed to take them daily, according to a review of Veterans Affairs medical records. Women and non-whites were least likely to take their prescriptions, as were the oldest and youngest patients."