OptiBiotix Health Plc
Publication of third human study on LP-LDL
By Elric Langton | 18th January 2022
OptiBiotix Health plc (AIM: OPTI), a wholly-owned subsidiary, ProBiotix Health Ltd, has published a third human volunteer study on its cholesterol-reducing probiotic, Lactobacillus Plantarum ECGC13110402, branded as LP-LDL, which is significant in several ways and may alert Big pharma to LP-LDL.
OptiBiotix's LP-LDL now has 3 studies showing excellent safety and efficacy. The key with this study is the excellent p values showing the high statistical significance and the reduction in LDL C which is a good as many statins plus the reduction in ApoB which is a protein linked to atherosclerosis (hardening of the arteries). I believe this is fairly unique so should attract a lot of interest from partners.
Previous studies have shown that LP-LDL -was safe and that the higher the starting level of cholesterol, the more significant the cholesterol reduction. This study aimed 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 the greatest commercial interest group to partners exploring the potential of LP-LDL as an OTC natural consumer health product or drug biotherapeutic.
The peer-review study published in the Journal of Functional Foods 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 when significant changes occurred in the original study, followed by a three-week washout period. The washout period removes the treatment and placebo and is used as a final confirmation that the effects are due to the treatment as cholesterol levels returned to their previous high levels when the treatment was removed.
The slide compares LP-LDL with statins and bempodoic acid, sold by Esperion pharma, who have $227m of sales.
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:-
I have provided a slide comparing LP-LDL with statins and bempodoic acid, sold by Esperion pharma, who have $227m of sales.
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 meaningful cardiovascular risk.
Cholesterol IP M&A Activity
Despite AstraZeneca previous failed attempts to develop a cholesterol-lowering drug, AstraZeneca bought rights to an orally-active drug that inhibits PCSK9, offering a patient-friendly alternative to current cholesterol-lowering therapies that have to be delivered via a needle in September 2020. This route is expensive. The most significant obstacle to uptake of the PCSK9 inhibitors is cost, with products launched in the US at a list price of around $14,000 per patient per year,
However, I wonder if they have given any thought to the growing adverse response to needles brought about by the pandemic?
PCSK9-targeting small interference RNA (siRNA) drug to reach $1.16 billion in sales by 2024 as a treatment for elevated blood cholesterol among the 80% or so of patients who don’t respond to older statin drugs.
November 2019 Novartis acquired The Medicines Company and its cholesterol-lowering drug for $9.7 billion, for access to Medicines Company’s phase 3 RNA-silencing drug in phase 3 development to lower levels of “bad” low-density lipoprotein (LDL) cholesterol. Yes, another needle proposition. My point is simple; Big pharma is seeking acquisitions as a strategy, and perhaps I am hinting at LP-LDL finding its way into the crosshairs of the big pharma. But, what would this mean for OptiBiotix? The data for LP-LDL is more compelling with each study; it can rival statins, if not replace specific versions of them. Worse case, work alongside and to reduce known side-effects. Will this be enough to attract M&A activity? Who knows, but I would wager we cannot rule it out now. Today’s RNS will have landed on some big pharma’s in-box by research staffers.
The alternative is Big pharma run with LP-LDL through the next phase, which seems to be phase 3, where the heavy lifting (cash expense) is needed to take this to the end-point. This means a second pharma partner, additional milestone payments with the view of royalties from sales if phase 3 studies are a success.
Yes, I am, of course, kite flying, but I do because LP-LDL is becoming more compelling with each new study data.
The next slide is clear. Again, LP-LDL beats Esperion Therapeutics and Pfizer stating across TC, LDL-C, Non-HDL-C and Apob.
Separately, OptiBiotix appoints Paul Cannings as Head of Operations & Quality at OptiBiotix, bringing more than 20 years of experience in the food industry role, Paul will be joining OptiBiotix from his former position as Business Unit Director at Knighton Foods.
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