Experts: Alexandre Persat (EPFL), Tomas de Wouters (PharmaBiome)
It is well established that the microbiome plays a key role in a multitude of chronic inflammatory and metabolic conditions. If research succeeds in better understanding such links, the microbiome will become a promising target for therapy and prevention. Use of the microbiome is relevant to the food and pharmaceutical industries, both of which have traditionally strong roots in Switzerland. Collaboration between industrial sectors offers an opportunity for new business models.
Picture: CDC, Unsplash
The microbiome is the totality of all microorganisms that live in a specific habitat. The human microbiome resides in organs that are exposed to the environment, including the skin, lungs, mouth and digestive tract. The colon has the highest density of microorganisms in the human body and is increasingly the target of research activities. The term "microbiome" is also used for other ecosystems, such as oceans, lakes or buildings.
In the last ten years, it has been recognised that the microbiome plays a key role in metabolic illnesses and chronic inflammation, but also in diseases of the immune and nervous systems: It acts as a mediator between the gut and the rest of the body. The first successful microbiome therapy was a milestone, the transplantation of a healthy donor’s entire microbiome, via the use of faeces, to treat recurring intestinal infections involving the bacterium Clostridium difficile – "bugs as drugs", so to speak. Using mouse studies, faecal transplantation is also being investigated as a treatment for other gastrointestinal and neurological illnesses, such as ulcerative colitis, multiple sclerosis and Parkinson’s disease. So-called "stool banks" centralise the screening of donors and the processing of faecal material to improve access to this unusual resource. Binding procedural guidelines are essential for safety and quality. Meanwhile, the first firms offering intestinal flora analysis and selling probiotics have emerged: a dubious combination, given the insufficient state of knowledge about such procedures.
The use of faecal material is not very appealing to patients. For this reason, researchers are seeking new forms of administration, such as enemas or pills, which were approved in 2022 or are close to approval. However, dependence on donors makes scaling up difficult. Future efforts are therefore currently directed towards using intestinal bacteria from culture, instead of from stool, for the therapy. Firstly, the product would then be a defined medicinal product with consistently the same composition and efficacy. Secondly, the procedure would be scalable and the risk of infections caused by unwanted bacteria in the transplant would be reduced.
Two other trends are emerging around the microbiome: "drugs for bugs", meaning the development of active substances that promote or specifically modify the human microbiome, and "drugs from bugs", in which the knowledge gained from microbiome research is used to isolate active substances from the microbiome and use them as medicinal products.
Microorganisms have a long tradition in the field of food supplements, where probiotic bacteria are used preventively. The most significant shift has been the expansion into medical applications. The basis for this approach is provided by the food and pharmaceutical industries, which have traditionally strong roots in Switzerland, show great interest in microbiome research and are cooperating with each other. Collaboration between industrial sectors offers an opportunity for new business models. Moreover, a majority of the Swiss population pays attention to a healthy lifestyle and is willing to spend money on health. Preventive lifestyle products are causing individuals to think more about the link between nutrition and health – with positive effects on the healthcare system. Although the temptation is great, the rule for normal citizens is: Hands off self-administered faecal transplantation, which carries a high risk of infection if not performed properly. Education is urgently needed here. In the medium to long term, microbiome therapies offer an opportunity for personalised preventive and therapeutic products.
To turn such promise into reality, progress in research is essential. This includes developing an alternative form of administration, such as a pill. That poses challenges for researchers because conditions in the digestive tract vary greatly. In addition, not only is there a need to build up fundamental understanding of the complex interrelationships, but the way in which experiments are set up must also be scrutinised. Instead of always carrying out experiments according to the same model, the potential of new technologies, such as big data analysis, should be tapped – an opportunity for Switzerland as a research location.
Information about the personal microbiome is on the same level as other health data. It allows conclusions to be drawn about where "owners" have been and how they behave – at least in terms of their diet. This raises ethical questions about privacy and control of this sensitive data.
If the products target the lifestyle segment, there are no regulatory hurdles standing in the way of commercialisation. However, if genetically modified bacteria are used, or if medical promises are sold along with the products, regulations come into play. It may be a disadvantage for Switzerland, but also for the whole EU, that the Food and Drug Administration (FDA) in the USA acts in a much more agile manner than the European approval authorities.
By funding the National Centre of Competence in Research "Microbiomes", the Swiss National Science Foundation is supporting a holistic approach that combines fundamental research with clinical applications. The Gebert Rüf Foundation, Avina Stiftung, Fondation Botnar and the Seerave Foundation are among the private organisations that have already supported microbiome research at an early stage. Switzerland could benefit from aligning its activities in a coordinated and technologically disruptive way, so that the large and important players seek their research collaborations in this country, rather than abroad. Switzerland’s industrial orientation also gives it the potential to take a leading role.
