Change of auditor
ProBiotix has made considerable progress since it was established and has successfully transitioned from a research and development specialist into a market-leading and profitable commercial organisation. ProBiotix is increasing its revenues and achieving global sales and recognition for its technologies and products, to the extent that ProBiotix has now signed over 41 agreements and its products are commercialised in 60 countries.
ProBiotix commercialises LPLDL® as an ingredient and in a range of white label (e.g., Ezimega 3) and own label products under its CholBiome range. It also receives milestone payments from a US partner, which is funding the development of LPLDL® as a drug biotherapeutic.
Lactobacillus plantarum LPLDL® is a next-generation probiotic that aids elements of cardiovascular and wellbeing. LPLDL® is able to improve blood lipid profiles and blood pressure using probiotic research, a holistic, non-pharmaceutical solution, to transform the way physical health is approached. Whereas high levels of cholesterol are commonly addressed with statins, which are drugs known to be associated with a host of undesirable side effects, LPLDL® offers a natural, scientifically founded alternative with no known side effects.
LPLDL® harnesses the microbiome-liver axis to positively impact upon the gut microbiome, using a naturally occurring strain of the bacterial species Lactobacillus plantarum, which demonstrates an exceptional capacity to modulate the metabolism of bile acids. This activity is important to bacterial survival in the intestine’s hostile environment and aids conditions such as high blood pressure and high cholesterol, as well as physiological processes including vitamin metabolism, glucose regulation and liver function.
LPLDL® was developed in conjunction with leading academics and, in a double blind, randomised, placebo controlled, study run by Reading University, it was found that LPLDL® reduced total cholesterol by up to 36.7 per cent, lowered LDL cholesterol by up to 13.9 per cent and increased HDL cholesterol by up to 4.5 per cent. In addition to this cholesterol lowering effect, LPLDL® was also found to reduce blood pressure levels by up to 5.1 per cent.
LPLDL® ’s outstanding stability in processing makes it a suitable ingredient for a broad array of functional food products and supplements in consumer and pharmaceutical health care. It has excellent survival and metabolic activity in high concentrations of bile salts and conditions in the intestine and has shown excellent survival to freeze-drying and stability at 25°C and 5°C over 24 months.
LPLDL® is manufactured in pharmaceutical GMP-certified facilities and protected worldwide by 5 patent families, comprising 27 patents, and 22 trademarks.
In February 2019, LPLDL® was designated Generally Recognized As Safe ("GRAS") by an independent Expert GRAS Panel in the United States, which extends its applications from use as a supplement to use as a functional ingredient in a wide range of food, dairy, and beverage products in the USA.
A recent example of ProBiotix’s product commercialisation progress has been in the US, where one of its partners, Seed Health (“Seed”), has received FDA authorisation for an Investigational New Drug (“IND”) application for DS-01™, a multi-strain probiotic that contains the patented LPLDL® from ProBiotix. This regulatory acceptance enables DS-01™ to enter a phase II randomised, triple-blind, and placebo-controlled clinical trial to investigate the role of the gut microbiome in patients with Irritable Bowel Syndrome (“IBS”) and the impact of DS-01™ on intestinal microbial communities. The strong scientific and clinical evidence that supports Seed’s whole genomic sequencing is one of the reasons for validating LPLDL® as a potential pharmaceutical product.
The CholBiome family currently comprises of 4 products, which can either be sold under the CholBiome brand or private label:
Contains LPLDL® as the only active ingredient, to focus on healthy cholesterol maintenance and deliver tangible health benefits.
A cholesterol-reducing formula that combines three targeted ingredients into a triple-layer tablet. It consists of LPLDL® , Monacolin K from red yeast rice, and Vitamin B3 (niacin) to deliver a tri-factor approach that utilises synergistic mechanisms of action to reduce cholesterol and aid overall cardiovascular health.
A blood pressure reducing formula that combines four science-backed natural ingredients, LPLDL®, Thiamine (Vitamin B1), L-arginine and Coenzyme Q10 to provide a multi-targeted mechanism approach for aiding hypertension and improving cardiovascular health.
A vascular health formula that combines three specialised ingredients in a triple layer tablet. Consisting of LPLDL®, Thiamine and Vitamin K2 Vital (from Kappa Bioscience) to provide a multi-targeted mechanism to work against the build-up of lipid and calcium deposits in the blood vessels.
In June 2018, ProBiotix signed an agreement with ALFASIGMA S.p.A., a multinational pharmaceutical company with 2018 revenues in excess of €1 billion and around 3,000 employees globally, to exclusively commercialise food supplements containing the Company’s cholesterol and blood pressure reducing LPLDL® strain in Italy. [Pursuant to this agreement,] Ezimega 3 was launched in January 2020 into the high value GP, hospital and pharmacy markets. In July 2020, ProBiotix entered into a non-exclusive distribution agreement with Actial Farmaceutica Srl (“Actial”) for the distribution of CholBiome® and CholBiome®X3 into the Asia Pacific region as cardiovascular extension to its VSL#3® brand, widely regarded as the world’s best known probiotic brand.
In October 2020, ProBiotix extended its partner agreement with United Italian Trading Corporation (Pte) Ltd in Singapore, to exclusively distribute ProBiotix’s cholesterol reducing product, CholBiomeX3, in Singapore, as part of its growth strategy into Asia.