More than 20 Spanish hospitals collaborate with Mikrobiomik in the clinical development of the first biological drug based on gut microbiota

The biopharmaceutical company, based at the BIC Bizkaia bioincubator, is also supplying its investigational biological drug MBK-01 under compassionate use


The Biscayan biopharmaceutical company, in its desire to help all those people suffering from serious illnesses for whom no effective curative treatments are available, is in the final phase of the clinical development of MBK-01, the first biological drug based on intestinal microbiota.

Mikrobiomik aspires to lead the paradigm shift of designing therapeutic solutions based on the human microbiome. In this sense, Dr. Juan Basterra, CEO of Mikrobiomik, states that they want to "fulfil the dream of being the first company worldwide to market in the European Union the first biological drug in the indication of Clostridioides difficile infection and under the innovative format of faecal microbiota capsules for administration in a single intake of 4 capsules, avoiding invasive procedures with risk of adverse effects and high cost, such as nasoduodenal tube or colonoscopy".

Currently, there is no gut microbiota-based drug on the pharmaceutical market. For this reason, there is a need to build an effective and safe therapeutic alternative in patients suffering from recurrent Clostridioides difficile infection who do not respond to antibiotics. 
Clostridioides difficile infection is becoming increasingly common in the world. Although in Spain the number of deaths is relatively low because the strains are not hypervirulent, in the United States the opposite is true, with more than 500,000 cases per year resulting in more than 30,000 deaths and a health care cost of around $2 billion.

Currently, 75% of patients respond to antibiotic treatment, but 25% have multiple recurrences leading to increased morbidity and mortality and, in some cases, death. In these patients, faecal microbiota transplantation has demonstrated efficacy of around 90% in the absence of relevant side effects and is endorsed as the most effective therapeutic option with the highest level of evidence in the treatment of Clostridioides difficile recurrence.