Small Company Champion & Lemming Investors Research and Newsletter Updates

Saturday, 7 November 2020

OptiBiotix Health - Seed Health FDA Approval


Friday, 2 October 2020

OptiBiotix Health - Seed Health FDA Approval for IBS Symbiotic Plus Big OptiBiome Launch

One of the more dynamic partners of OptiBiotix Health Plc (OPTI), Seed Health Inc of the USA has another blockbuster project underway which is aimed at treating Irritable Bowel Syndrome (IBS). Moreover, like their first symbiotic, which is reportedly had a 400% surge in sales since July 2019, also contains OptiBiotix LP-LDL®. 

FDA Investigational New Drug authorisation for a product containing LPLDL ® 

OptiBiotix announced Seed Health, has received FDA authorisation for an Investigational New Drug (“IND”) application for DS-01™, a broad spectrum multi-species, multi-strain probiotic which contains OptiBiotix’s Lactobacillus Plantarum LPLDL ®. The regulatory acceptance enables DS-01 to enter a Phase II randomised, triple-blind, and placebo-controlled a 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. 

OptiBiotix previously announced (RNS: 22 May 2018) that it had entered into a non-exclusive agreement with Seed to produce, promote, market and commercialise products containing LPLDL ® in the USA and the launch of Seeds Daily Synbiotic™ (RNS: June 7 2018) to consumers on its online platform This FDA authorisation extends the opportunity into new drug and application areas for IBS. 

Stephen O’Hara, CEO of OptiBiotix, commented: “We are pleased to see that Seed has achieved FDA authorisation for an IND in a product containing OptiBiotix’s Lactobacillus Plantarum LPLDL ®. OptiBiotix has whole genomic sequencing, built on a strong scientific and clinical evidence base, obtained FDA GRAS, and pharmaceutical GMP manufacture validation for LPLDL ® which has created the potential for LPLDL® to be commercialised as a pharmaceutical drug product. Seed health is one of several partners OptiBiotix is working with to bring a range of cardiovascular, general health, and IBS applications to supplement and pharmaceutical markets around the world.” 

This speaks to the science-based evidence behind OptiBiotix's IP. The FDA undertook a long and protracted evidence-based fact-finding mission which took some 2-years for FDA approval for LP-LDL. Moreover, with today's announcement, the FDA has legitimised LP-LDL for the inclusion of pharma-grade products. This is significant not just for Seed, but another US pharma currently developing a pharma product with LP-LDL and of course, OptiBiotix. And remember, these developments have no cost baring to OptiBiotix, these developments only add value to the IP and help build the LP-LDL brand, a thing of beauty of the B2B model. However, it does have its downsides - It can take longer to develop new products containing new science until science is adopted as we are now seeing with LP-LDL, SlimBiome, OptiBiome, WellBiome, CholBiome products. The downside, is sometimes we have a situation like today - OptiBiotix appears to be caught out by the news because investors are always seeking information and sometimes this partners like Seed have neglected to keep a partner informed of developments containing their IP.  

"Given the valuation of pharma companies in this area (particularly the USA), this is excellent news for investors and sets the scene for LP-LDL to be used in other drug applications.  It also further validates our approach to take a more rigorous and scientific approach than traditional probiotic companies to open up a wider range of opportunities and create real product differentiation. The use of LPLDL in pharma enhances the credibility of the product in the other markets.  We can see an increased use for LPLDL in pharma now that we have FDA GRAS, and pharmaceutical GMP manufacture validation."

I pointed of a bleeding obvious, in that FDA approval is very significant game-changing news, to Stephen O'Hara; Yes, this is very significant news. I hope people can see that we are building up multiple opportunities and within areas like SlimBiome® and LP-LDL® building the science and regulatory approvals to open up multiple markets in food, dairy, medical foods and of course pharma (riskier but a shot to nothing as others are paying). Add to that the microbiome modulators and our 3 SweetBiotix programs, and you can see the scale of the opportunity."

GRAS is a United States Food and Drug Administration (FDA) designation that any substance added to food is considered safe by experts. GRAS status is therefore required for the use of these substances in foods. In the case of probiotics, it is a strain-specific process in which all strains not described before 1958 – as is the case of LPLDL® - must be categorised as GRAS if they are to be added to foods. GRAS assessment involves submitting an extensive technical dossier for evaluation by an independent panel of experts. They confirm if the ingredient is safe, under what conditions it can be used, and for which applications.

The Expert GRAS Panel that reviewed the LPLDL® dossier was formed by international experts in toxicology, pharmacology and regulatory affairs. After evaluating the information on LPLDL®’s science, genetic composition, lack of antibiotic resistance, human clinical study results and market feedback, the Panel members concluded that the evidence was sufficient to determine that LPLDL® is safe for use in food and beverage categories at a concentration of up to 10 billion colony forming units (CFU) per serving. This is more than double the dose found to significantly reduce cholesterol and blood pressure in the human trial conducted by Reading University (Costabile et al., 2017). 

I send OptiBiotix CEO. Stephen O'Hara the following for comment: "Yes - our LP-LDL in a drug. That’s always been the plan.  A range of products with multiple opportunities in ingredients, supplement, medical device, and pharma markets which reduce risk and gives investors a multiplier.   The medical device and pharma use also enhances the credibility of the product in the other markets.  his is great news for investors." 

A recent Zeon conference with their clients, Stephen alludes to the imminent launch of OptiBiome in Optipharma's launch of their Australian No1 weight management product will be launched in 20 territories. As you can see from the screengrabs, the launch is already underway, which means a big uplift in H1 revenues, and perhaps some may land in H2 2020? This particular presentation can be seen here.

  • 9.20 Stephen presents SlimBiome
  • 13.20 Stephen explains the growth of SlimBiome in 149 countries

Examples of some of the retail access Optipharm has. I think the Chemist Warehouse maybe the initial online launch. 

Chemist Warehouse is an Australian company operating a chain of retail pharmacies. The company is Australia's largest pharmacy retailer, with over 350 stores and employs over 8,000 staff.

Founded in 1914 in Collingwood by George Coles, Coles operates 807  supermarkets (1502 including Coles and Coles Express) throughout Australia, including several now re-branded Bi-Lo Supermarkets. 

The market is asleep where OptiBiotix is concerned. Currently, only fully paid up members of the OptiBiotix club seem capable of looking under the bonnet and seeing there as V12 under the bonnet, not a two-stroke lawnmower engine. With larger and larger partners developing new products in 170 countries, it sure follows our time will come. The question you should be asking yourself, do I have enough and should I stop trading it and keep what I have? How much derisking against Brexit, and or COVID-19 do you need? This is very different from a single technology, single product investment, as risks are spread, and opportunities are large. The only real risk associated with OptioBiotix is boredom or the products not selling. The latter is mitigated with carefully selected companies with a history of multi-year growth, plus the human biome is a hotbed of activity now, more so due to the pandemic. Unlike so many companies banging the COVID-19 drum, OptiBiotix BOD has barley beaten the tambourine. It is almost as though the company is seeking to take care of the world poor health by stealth. 

For now, I am preaching to the converted. Wider acknowledgement of OptiBiotix is needed. Maybe when OptiBiotix blows the doors off revenue expectations, we will see this happen. That, or an RNS of a blockbuster deal that is written on a keyboard with numbers on it. This is where you come in...share via the forums, SM platforms.