The Basque biopharmaceutical company Mikrobiomik, founded in 2018 and owned by Seed Capital Bizkaia, thus becomes the first European company to obtain an authorisation under the new European SoHO Regulation.
Mikrobiomik marks a new milestone in its development with the European approval of EUTEGRA (MBK-01), the first gut microbiota-based biological therapy for the treatment of Clostridioides difficile infection (CDI). With this approval, Mikrobiomik becomes the first laboratory authorised in Spain to prepare and process faecal microbiota for this therapeutic indication.
A pioneering development in microbiota-based therapies
EUTEGRA (MBK‑01) is an oral capsule therapy developed using FSPIM ® (Full Spectrum Purified Intestinal Microbiota) technology, which includes the entire bacterial ecosystem of a validated healthy donor. It aims to restore the functional microbiota in patients with recurrent infections.
This treatment reduces CDI recurrences by more than 50% compared to the antibiotic standard, offering significant clinical and economic benefits to the health system.
A significant regulatory milestone in Europe
The authorisation has been processed through the Autonomous Coordination of Transplants of the Basque Country, with technical evaluation by the National Transplant Organisation (ONT) and the SoHO Innovation Evaluation Committee. This makes Mikrobiomik the first entity in Europe to successfully pass the new regulatory framework for substances of human origin.
Health impact and future outlook
CDI is the primary cause of antibiotic-associated diarrhoea in developed nations, with an incidence in Spain of 171 cases per 100,000 admissions and an estimated annual cost of 32.1 million euros to the National Health Service.
EUTEGRA (MBK‑01) introduces a new therapeutic category that can reduce recurrences, decrease antibiotic dependence and improve clinical outcomes in vulnerable patients.
Seed Capital Bizkaia’s commitment to biotechnological innovation
Seed Capital Bizkaia thus marks this milestone, emphasising the potential of Bizkaia’s entrepreneurial ecosystem to develop therapeutic solutions with a worldwide impact.
This approval, obtained by Mikrobiomik, also strengthens the Provincial Council of Bizkaia’s mission to support innovative projects that can transform key sectors and improve people’s quality of life.