EU biotech firms unite in pushing for ‘harmonised' microbiome therapeutics regulation

The Intestinal Microbiome-based Medicines European Task Group (IMM-ETG​​) involves Caelus Health, EnteroBiotix, Ferring Pharmaceuticals and MaaT Pharma along with the Pharmabiotic Research Institute (PRI).

“The IMM-ETG has been established to contribute to a harmonised regulatory framework in Europe for the intestinal microbiome products based on the whole ecosystem,”​ said Dr Luc Sterkman, CEO of Caelus Health.

“In addition, we would like to obtain a universally accepted product classification of these products.​

“In the process of achieving these two initial objectives, the IMM-ETG aims to interact with key stakeholders and to facilitate close and open communication with academic groups, clinicians and last but not least regulatory bodies.”​

Current FMT laws ​

Current European FMT regulation and classification falls within the responsibility of each Member States’ respective authority, creating a patchwork of regulation for companies to navigate.

Most of the 30+ active clinical trials involving FMT in Europe are mainly sponsored by academics and are regulated on a national basis, which the IMM-ETG said would need regulation sooner rather than later.

FMT in particular has emerged as a procedure with demonstrative benefits in addressing recurrent Clostridium difficile​​ infection.

In this context, the faecal microbiota administered here is regulated as a drug in several countries such as France, Germany, United Kingdom, Switzerland, United States and Canada.

Its efficacy for treating chronic diseases may well be the next step for researchers as they look to trial this approach for new microbiome-associated conditions like Alzheimer's, multiple sclerosis and asthma.

The EU commission has previously released a position which stated that when administered into a recipient with therapeutic intention, the "active components"​ of the faecal microbiota are not the human cells.

In light of this, faecal microbiota is not considered as falling within the scope of Directive 2004/23/EC on human tissues and cells legislation and may be considered as a medicinal product.

“The IMM-ETG proposes that products defined as intestinal microbiome whole ecosystem-derived are medicinal products,”​ they said.

“This is in so far as they are intended to ‘treat or prevent disease in human beings’ and are to be regulated according to Directive 2001/83/EC across all EU Member States ​

“This is as long as they are ‘intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.” ​

Industry convergence ​

IMM-ETG’s creation may well be an indication of the direction a number of industries are leaning towards.

With interest from food, nutrition and pharma, the ever-growing research that points to the role the gut microbiome plays in health has put each sector on alert as an avenue of great potential and profit.

“It is clear that the diet and composition of nutrition has a significant impact on the microbiome,”​ said Dr Sterkman.

“However, the type of products under development by the members of the IMM-ETG are intended to be developed and commercialised as medicinal products. In that sense, this initiative will contribute to a clear distinction – at least from a regulatory perspective.​

“Based on personal analysis of the microbiome, an individual disbalance or deficiencies may be identified.​

“However, if a broad well-established whole ecosystem product is prescribed, it may address the individual needs of different patients suffering from different disorders; obviously this is all subject to clinical validation of the various products which are under development.”​

Many pharmaceutical companies currently have or are in the process of developing a consumer healthcare division, which are already active in probiotic and gut microbiome research.

Chr. Hansen applied its microbiome expertise in the pharma arena as the firm entered a collaboration with Lonza to produce live biotherapeutic (LBP) products to address gastrointestinal and cardiovascular conditions.

In a 50/50 joint venture formed last month, the two multinationals would develop and manufacture these products that will see around €90m shared between the partners over three years.

In March, French-based LNC Therapeutics revealed details of its efforts in developing a drug candidate targeting the gut microbiota and its role in energy metabolism and the onset of obesity and metabolic disorders.

Out of the IMM-ETG's biotech firms, Ferring remain the front runner in launching a microbiome-based treatment. Its 2018 acquisition of Rebiotix, a US microbiome firm means its phase III trial looking into C. difficile ​infections is on schedule.

Meanwhile, MaaT Pharma is in the midst of a phase II trial, looking into the microbiome’s role in subjects with blood cancer.