Pharmacologically potent strains: OTC-supplements interface zones in on probiotic potential

03 Oct 2019 --- A string of recent forays by health and nutrition companies into the over-the-counter (OTC) space has sparked discussion around the interface between supplements and medications. Whether a product is regulated as a therapeutic good or as a supplement is of extreme importance as it dictates how the product can be marketed and what regulatory requirements it needs. Supplements, for example, fall within the food products category and therefore are not regulated by the strict standards governing the sale of prescription and OTC drugs. NutritionInsight takes a look into this arena and how the lines between certain nutritional spaces, such as pre- and probiotics, are becoming increasingly blurred.

Bringing pharmaceuticals to market can be challenging, in part due to shifting regulatory patterns. Last year, however, a number of high-profile acquisition heightened the OTC-supplement platform. 

Pharma heavyweights GlaxoSmithKline plc (GSK) and Pfizer Inc. entered into a “new world-leading” joint venture (JV), with combined sales of approximately £9.8 billion (US$12.7 billion). Meanwhile, Procter & Gamble (P&G) acquired Merck KGaA’s, German consumer health unit in a US$4.2 billion acquisition. P&G hoped to boost its own health care capabilities, such as with vitamins and supplements, and give itself a stronger foothold in global markets.

Meanwhile, earlier this year, Chr. Hansen created a 50/50 JV with pharma contract manufacturing company Lonza, coined BacThera. The bioscience company sought to take its experience in working with bacteria and apply that in the adjacent pharma industry.Bringing pharmaceuticals to market can be challenging, in part due to shifting regulatory patterns. 

“We will offer unique development and pharma-grade manufacturing that addresses an unmet need in the industry, enabling customers to deliver therapies for patients,” Christian Bigum, Interim CEO of BacThera, tells NutritionInsight. 

Indication areas that are currently in clinical trials by potential customers include gastrointestinal diseases, metabolic diseases (obesity, diabetes), nervous system diseases (Parkinson’s), infection diseases, oncology, skin disorders, autism and asthma. BacThera will manufacture bacteria strains from strict anaerobic microbes through to formulation and dosage forms.

“The JV will possess leading competences in handling, characterizing, formulating, manufacturing and encapsulating strict anaerobic bacteria. These competencies under one roof, with seamless exchanges between drug substance and drug product activities, will decrease development timelines and increase the chance of ‘right-first-time,’” he notes.

He adds that while Chr. Hansen contributes its know-how in developing, upscaling and manufacturing bacteria strains, Lonza brings capabilities in pharma contract manufacturing and formulation and drug delivery technologies.

Probiotic potentials
The rapid growth of the probiotic segment and exciting research on the importance of human microbiota have increased interest from pharma companies, and their consumer healthcare divisions in probiotic product development.

“The probiotic market [is set to] continue to grow. Consumer demand for clinically documented probiotic products will increase as consumer awareness and probiotic knowledge increases,” Linda Neckmar, Vice-President EMEA & APAC at Probi, tells NutritionInsight.Probiotics have attracted wide-ranging interest in part due to their broad application in health areas

In an example of this interest, Probi signed a long-term agreement with Cilag, a member of the Johnson & Johnson Family of Companies, for the development of a probiotic product.

Probiotics have attracted wide-ranging interest in part due to their broad application in health areas, such as bone health, celiac disease, gastro health, acute stress, sport performance, oral health and the role that next-generation probiotics could one day play.

Specific strands: The future?
A specific strain should be brought to the fore here. Found to be beneficial for cardiovascular disease, among other health measures, the strain Akkermansia muciniphila (A. muciniphila) has been attracting attention.

In July, supplementation with the pasteurized form of gut-bacteria was found to reduce cardiovascular risk factors, moderate pre-diabetes progression, as well as lower cholesterol levels in obese participants. A further study found it could slow the development of amyotrophic lateral sclerosis (ALS), according to researchers at the Weizmann Institute of Science, Israel. 

The commercial form of A. muciniphila as a dietary supplement will be developed by the University of Louvain and the University of Wageningen’s spinoff company – A-Mansia Biotech. Last year, the company raised €13 million at the close of Series A financing, which allowed them to push forward with their A. muciniphila bacterium research.

As the microbiome platform continues to expand in terms of clinical research, the efficacy of particular strands for specific health outcomes can be expected to grow – and attract further investment. 

The efficacy of particular strands for specific health outcomes can be expected to grow and attract investment. In this vein, microbiome start-up Vedanta Biosciences – developers of a new category of therapies for immune-mediated diseases using live human microbiome-derived bacteria – raised an additional US$18.5 million in its third round of financing this week, bringing the total funding to US$45.5 million. 

Vedanta Biosciences specializes in the identification and cultivation of human commensal bacteria that induce a range of immune responses, including regulatory T cells, CD8+ T cells and Th17 cells, among others. These advances have been published in peer-reviewed journals, including Science, Nature, Cell and Nature Immunology. Vedanta Biosciences worked with these biological insights to generate a pipeline of treatment programs for infectious diseases, autoimmune diseases, allergies and immuno-oncology.

“Our platform has the potential to address broad medical needs, including the treatment of drug-resistant infection, food allergies and other immune-mediated conditions where current approaches fall short,” says Bernat Olle, PhD, Co-Founder and CEO of Vedanta Biosciences. 

Among the company’s operational capacities are a suite of proprietary assays to select pharmacologically potent strains, datasets from human interventional studies and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form.

What’s next?
As knowledge around the microbiome continues to expand, boosted by ongoing clinical research in the area, there is ample space for NPD activity in the pharma category.

“Research is now focused on investigating the microbiota. People are trying to identify markers in the hopes of preventing or diagnosing health problems and diseases,” Bérengere Feuz, Marketing Director, Lallemand Health Solutions, tells NutritionInsight.

By Laxmi Haigh