Mikrobiomik has obtained approval for EUTEGRA (MBK-01) as the first gut microbiota-based biological therapy authorised in Spain under the new European SoHO Regulation.
This is a pioneering advance:
- First innovative therapy in oral capsules based on microbiota for Clostridioides difficile infection (CDI).
- First authorization in Europe under the new SoHO regulatory framework.[1]
- The treatment has been administered to more than 200 patients in 35 Spanish hospitals in the compassionate use program and during the phase III clinical trial.
EUTEGRA (MBK-01) reduces recurrences by more than 50% compared to standard antibiotic treatment and can lead to significant savings for the healthcare system in a disease that represents one of the main hospital infections in developed countries.
This achievement not only opens a new therapeutic category in microbiota, but also positions Spain as a benchmark in the implementation of the SoHO Regulation and in the development of innovative biological therapies.
This is a step forward for biomedical innovation, the sustainability of the healthcare system and, above all, for patients who needed new therapeutic alternatives.
Download the press release (PDF) here.
[1] Regulation (EU) 2024/1938 SoHO (Substances of Human Origin)
