The first orally administered biologic medicine based on intestinal microbiota: fiction or reality?

Mikrobiomik aims to be the first company in the world to commercialize the first biologic medicine based on intestinal microbiota, in primary or recurrent Clostridiodes difficile infection, through the administration in a single dose of 4 capsules of freeze-dried fecal microbiota with FSPIMR technology (full spectrum & purified intestinal microbiota).

Mikrobiomik has ongoing a randomized, controlled and open-label Phase III clinical trial in 21 hospitals in Spain, for patients with primary or recurrent Clostridiodes difficile infection, to evaluate the efficacy and safety of its investigational biologic medicine MBK-01 (FSPIMR capsules, full spectrum & purified intestinal microbiota) vs. fidaxomicin. 

This is the world's first clinical trial of a gut microbiota-based drug involving patients with a primary episode and compared against a gold standard active comparator, fidaxomicin, and not against placebo. 

Mikrobiomik will publish by the end of the first trimester 2023, the intermediate results of MBK-01 efficacy (primary endpoint, non-recurrence at 8 weeks) and safety, after having recruited more than 50% of the necessary patients in order to complete this pivotal clinical trial that will allow it to apply for registration in the very near future. In parallel, Mikrobiomik supplies MBK-01 under compassionate use to any Spanish hospital that requests it, after prior authorization by the AEMPS (Spanish Agency of Medicines and Health Products).

Mikrobiomik manufactures under GMP (Good Manufacturing Practices) conditions in its facilities certified by the AEMPS in the Technological Park of Derio, authorized for the distribution of MBK-01 at Europe as biologic medicine under investigation, exclusively for its own clinical trials or those of third parties.

Mikrobiomik will launch during the first quarter of 2023 a Phase II vs. placebo clinical trial in the indication of NASH (non-alcoholic steatohepatitis) and a proof-of-concept trial in metastatic stomach, pancreatic and colorectal cancers that do not respond to 2-3 lines of treatment.