Akkermansia for weight management: EFSA approves A-Mansia Biotech’s next-gen bacterium

06 Sep 2021 --- The European Food Safety Authority (EFSA) has approved the first next-generation bacterium, Akkermansia muciniphila, which was isolated from human gut microbiota.

The pasteurized ingredient is produced by A-Mansia Biotech, which now aims to market it as a food supplement for weight management in 2022.

“Products based on A. muciniphila open the door to a new generation of nutritional supplements, rooted in a deep understanding of microbiome function,” says Michael Oredsson, CEO.

“This EFSA authorization is a crucial milestone that will enable A-Mansia to progress toward the launch in Europe of our first product in 2022,” he continues. 

A-Mansia Biotech had initially submitted its Novel Food application to the European Commission in October 2019. 

After an extensive scientific review, EFSA’s panel concluded that the ingredient is safe as a food ingredient at the specified conditions of use and intake levels. This is 3.4 × 10¹⁰ cells per day, provided that the number of viable A. muciniphila is below 10 cells per g.Pasteurized A. muciniphila can help prevent the deterioration of health, according to some studies.

Addressing the obesity epidemic
A. muciniphila has been found to restore the gut barrier function, thereby leading to reduced inflammation and eventually better control of fat storage, glucose metabolism and energy expenditure.

A-Mansia Biotech highlights that the ingredient is well-positioned to tackle a global health crisis, where one in two people is overweight and has several cardiovascular risk factors. In the UK, for example, obesity was a factor in over a million admissions to National Health Service (NHS) hospitals last year. 

A-Mansia Biotech also points to dozens of scientific articles and a human study demonstrating the ability of pasteurized A. muciniphila to prevent the deterioration of subjects’ health status, such as pre-diabetes and cardiovascular risks. 

This is coupled with a decrease in inflammation markers in the liver, insulin resistance or hypercholesterolemia.

Multi-step process for powder
The patented production process for pasteurized A. muciniphila is based on anaerobic fermentation followed by pasteurization of the bacterial cells and freeze-drying.

Notably, the pasteurization process raises the effectiveness of A. muciniphila. Pasteurized A. muciniphila is stable, has a long shelf life of around a year and is easy to administer to humans.

EFSA’s review expands on the production process, explaining that an inoculum of A. muciniphila is made by successive preculture steps in liquid media in strictly anaerobic conditions at increasing volumes in order to prepare for the inoculation of the main fermenter. 

The main fermentation is conducted under strictly anaerobic conditions at a certain temperature and pH – which is confidential information – while stirring. The growth of A. muciniphila is monitored via spectrophotometry at regular time points.

The resulting cells are eventually mixed with cryoprotectants and freeze-dried in order to produce a powder. This is then packaged into waterproof and airproof multi-layer pouches, heat-sealed and stored at ≤ –18°C until the powder is packed in final products. 

These are to be stored (e.g. by wholesalers, retailers, consumers) at 15-25°C, protected from light and moisture. The powder has a proposed shelf life of one year. 

Over a decade in the making
A-Mansia Biotech is a Belgian co-spin-off of Wageningen University and UCLouvain. Akkermansia was first discovered, isolated and characterized from the human gut microbiota in 2004, in the laboratory of Willem de Vos, a professor at Wageningen University and the co-founder of A-Mansia.

Shortly thereafter, the team of Patrice Cani, professor at UCLouvain and another co-founder of A-Mansia, discovered the beneficial effects of the bacteria.

The company has been supported by several grants from the Walloon region. It previously secured €18 million (US$21 million) series A financing led by Seventure Partners, which recently saw ADM invest in its Health for Life Capital Fund II.  

Other industry players have also been closing in on the next-generation probiotic space, with Winclove Probiotics developing its Novobiome platform. 

Also, The DuPont Human Microbiome Venture is partnering with The Procter & Gamble Company to develop next-generation probiotics for human health. 

By Katherine Durrell