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Mikrobiomik

Mikrobiomik

Granada, Spain· Est.
mikrobiomik.net
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Private Company

Total funding raised: $500K

Overview

Mikrobiomik is a clinical-stage biotech pioneering the development of standardized, capsule-based fecal microbiota transplantation (FMT) therapies. The company has achieved a significant milestone with the European authorization of its lead product, MBK-01, for recurrent CDI under the new Substances of Human Origin (SoHO) regulation, positioning it as a leader in Spain. Its pipeline includes a Phase III trial in decompensated liver cirrhosis and a Phase II study in recurrent acute diverticulitis, targeting substantial unmet medical needs. As a private company, Mikrobiomik is transitioning towards commercialization while expanding the clinical applications of its proprietary FSPIM® technology platform.

Infectious DiseaseGastroenterologyHepatology

Technology Platform

FSPIM® (Full Spectrum Purified Intestinal Microbiota) technology for standardized, capsule-based fecal microbiota transplantation (FMT).

Funding History

1
Total raised:$500K
Seed$500K

Opportunities

The authorization of MBK-01 for CDI provides a first-mover advantage in the European microbiome therapy market and a near-term revenue stream.
Expanding its use into large, underserved markets like decompensated liver cirrhosis and diverticulitis represents a significant long-term value driver, leveraging the same core platform.

Risk Factors

Key risks include the commercial execution challenge of launching a novel therapy, the clinical risk of ongoing late-stage trials failing to meet endpoints, and increasing competition in the microbiome space.
Scaling manufacturing of a donor-derived biological product also presents operational complexity.

Competitive Landscape

Mikrobiomik competes in the growing field of microbiome therapeutics, facing other companies developing FMT-based products and live biotherapeutic products (LBPs) for CDI and other indications. Its key competitive advantages are its first European SoHO authorization in Spain and its oral capsule formulation. However, larger pharmaceutical companies are also entering the space, potentially increasing competition.

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