The Basque biopharmaceutical company Mikrobiomik backed by Seed Capital Bizkaia, has become the first European company to obtain authorization under the new European SoHO Regulation.
Mikrobiomik marks a new milestone in its development with the European approval of EUTEGRA (MBK‑01), the first microbiota-based biological therapy for the treatment of Clostridioides difficile infection (CDI). With this approval, Mikrobiomik becomes the first laboratory authorized in Spain for the preparation and processing of fecal microbiota for this therapeutic indication.
A pioneering advance in microbiota-based therapies
EUTEGRA (MBK‑01) is an oral capsule therapy developed using FSPIM® (Full Spectrum Purified Intestinal Microbiota) technology, incorporating the full bacterial ecosystem of a validated healthy donor. Its aim is to restore a functional microbiota in patients with recurrent CDI.
This treatment reduces CDI recurrence by more than 50% compared to standard antibiotic therapy, representing a significant clinical and economic impact for the healthcare system.
A benchmark regulatory achievement in Europe
The authorization was processed through the Basque Autonomous Transplant Coordination, with technical evaluation by the Spanish National Transplant Organization (ONT) and the SoHO Innovation Evaluation Committee. This process makes Mikrobiomik the first entity in Europe to successfully navigate the new regulatory framework for human-origin substances.
Healthcare impact and future outlook
CDI is the leading cause of antibiotic-associated diarrhea in developed countries, with an incidence in Spain of 171 cases per 100,000 hospital admissions and an estimated annual cost of €32.1 million to the National Health System.
EUTEGRA (MBK‑01) inaugurates a new therapeutic category capable of reducing recurrences, decreasing antibiotic dependency, and improving clinical outcomes in vulnerable patients.
Seed Capital Bizkaia’s commitment to biotech innovation
Seed Capital Bizkaia celebrates this milestone, which demonstrates the potential of Bizkaia’s entrepreneurial ecosystem to generate globally impactful therapeutic solutions.
This approval achieved by Mikrobiomik also reinforces the mission of the Diputación Foral de Bizkaia to support innovative projects capable of transforming strategic sectors and improving people’s quality of life
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