Mikrobiomik has become the first organisation in Spain to receive authorisation to prepare and process faecal microbiota for treating Clostridioides difficile infection, following approval of its oral therapy EUTEGRA (MBK-01).
The Basque biopharmaceutical company, founded in 2018, has positioned the treatment as an alternative to the antibiotic‑based standard of care for a condition that remains the leading cause of antibiotic‑associated diarrhoea in developed nations.
The therapy uses FSPIM technology, a full spectrum purified intestinal microbiota approach delivered in capsule form. It is the first microbiota transplant‑based treatment to be authorised in Spain under the strengthened European Regulation on Substances of Human Origin, introduced in June 2024. The new framework sets out reinforced requirements on quality, traceability, safety and clinical efficacy.
The approval process was coordinated through the Basque Country’s Regional Transplant Coordination and evaluated by the National Transplant Organization and the SoHO Innovation Evaluation Committee, which operates under the Transplant Commission of the Interterritorial Council of the National Health System.
Mikrobiomik has now opened discussions with Spain’s Autonomous Communities to enable the distribution of EUTEGRA (MBK-01) in hospitals across the country.
Dr Patricia del Río, executive director of Mikrobiomik, said: “The European authorization of EUTEGRA is a major boost for Mikrobiomik and, above all, for the thousands of patients who currently have no alternatives to standard antibiotic-based treatment for CDI.”
She explained: ‘Being the first Spanish and European company to obtain authorization under the new SoHO Regulation will also help to drive the future development of innovative microbiota-based therapies.’
