MBK-01

MBK-01 is a microbiome-based therapeutic being developed by the Spanish biotech company Mikrobiomik. It is an oral capsule formulation containing lyophilized, full-spectrum, purified intestinal microbiota derived from healthy donors, a technology Mikrobiomik calls FSPIM® (Full Spectrum Purified Intestinal Microbiota). [3, 9] The principle behind MBK-01 is to restore a healthy gut microbial ecosystem (eubiosis) in patients with an imbalance known as dysbiosis. This approach, a form of fecal microbiota transplantation (FMT), is being investigated to prevent disease recurrence and manage symptoms. [3] The product, also known by the brand name EUTEGRA, received authorization in Spain for treating Clostridioides difficile infection under the European Regulation on Substances of Human Origin (SoHO). [6, 9] Clinical trials are also underway for other indications, including recurrent diverticulitis, decompensated liver cirrhosis, and nonalcoholic steatohepatitis (NASH). [3, 5]

Brand names

EUTEGRA

Other names

FSPIMFull Spectrum & Purified Intestinal Microbiotaheterologous lyophilized intestinal microbiota oral capsulesallogeneic faecal microbiota (oral capsules)