Posted by Juan Basterra – 21/12/2023
It all begins with a small effort that can save lives. At Mikrobiomik our raw material is “the poop”, yes, we work with human stool to which we give no value by pulling the chain daily, unless we are of intestinal transit, let’s say constipated.
Our technology makes it possible to extract the intestinal microbiota, the ecosystem of microorganisms that colonize our intestine, the large intestine, and that come from a validated healthy donor. At the end of this process, this healthy microbiota, previously freeze-dried, is conditioned in capsules resistant to the acidity of our stomach, in order to be released into the large intestine of a patient with a damaged microbiota. Basically, we activate the reset button, replacing a diseased microbiota for a healthy one. And this is the working mechanism of our first biological and investigational medicine, MBK-01, which replaces a microbiota that is often complicated due to antibiotic administration, with the active microbiota of one of our donors.
At Mikrobiomik we have completed a phase III pre-marketing clinical trial of MBK-01 in a disease that mainly affects older hospitalized patients, who have multiple diseases and therefore are taking a lot of medications. Clostridioides difficile is called “the bug”, a bacterium that causes very severe episodes of diarrhea and can cause the patient’s death. Although it is a disease that is most often caused by taking antibiotics, ironically it is treated with antibiotics and, in 1 out of 4 patients, it is not cured, so the patient is sent back to the hospital with severe diarrhea.
MBK-01 is the first non-antibiotic antibiotic, meaning that it cures just like an antibiotic, but in a natural way, replacing the damaged microbiota of patients with this bacterium, whose last name says it all, with the healthy microbiota of one of our validated donors.
At Mikrobiomik we supply in altruistic way our MBK-01 to those patients with this bacterium who could not be included in our trial, but in whom antibiotics have not had any effect. And, as we are from Bilbao (sic), we will be the first company in the world to market in the EU the first biological medicine based on intestinal microbiota and, moreover, in a simple and convenient way for the patient: a single dose of 4 capsules.
We are proud to say that, for the first time in the Basque Country’s pharmaceutical industry history, a drug researched, developed, and produced in Bizkaia, has been qualified by the EMA (European Medicines Agency) as a new active substance, which gives us 10 years of market exclusivity.
We will launch MBK-01 in the first half of 2025, after years of effort together with the talent of the Mikrobiomik team, of which I am more than proud, honored to have worked and to work with them.
But to reach our dream, we will continue to need the small effort of donors who want to save lives, so we encourage all people between 18- and 54-years old living in Bizkaia, to be encouraged to be donors, collaborating in the development of this medicine, providing a raw material that saves lives.
Juan Basterra
