European microbiome biotechs have launched a collaboration to streamline the EU’s regulatory pathways for fecal transplants, which have the potential to treat inflammatory disease and bacterial infection.
The companies will propose EU regulatory changes that make it easier to commercialize treatments based on transplanting fecal bacteria into a patient’s gut. Fecal transplants are types of microbiome-based treatments, a young field in the industry that has big potential to treat diseases such as inflammatory bowel disease and even cancer.
Unlike with more traditional treatments, the EU lacks a centralized classification for fecal transplants, leaving the member states to regulate it separately. This discourages companies from developing fecal transplants in Europe.
It’s more important than ever for the member companies to have the regulations reformed. Several members, such as MaaT Pharma and Ferring Pharmaceuticals, are powering through clinical trials and getting closer to submitting for regulatory approval.
“The time has come to prepare for commercialization,” Hervé Affagard, CEO of MaaT Pharma, told me. “Each of these companies requires clear and consistent regulatory classifications and guidelines to enable the development of their microbiome products.”
Affagard told me that the consortium will meet up in the next few months, and he has high hopes that it will achieve its aims. “I’m expecting this [issue] to be overcome sooner rather than later based on the significant interest from national agencies in achieving a unified position.”
The members of the collaboration include the French Pharmabiotic Research Institute, Dutch Caelus Health, Scotland-based EnteroBiotix, French MaaT Pharma, and Swiss Ferring Pharmaceuticals. Ferring has been the closest to launching a fecal microbiota transplant since last year when it acquired Rebiotix, a US microbiome company running a phase III trial to prevent Clostridium difficile infections.
Next in line is MaaT Pharma, which is running two phase II trials. One trial is investigating the treatment’s potential in patients with blood cancer, and the other is testing the treatment in bone marrow transplant patients whose new immune cells attack the patient’s tissues.
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