100 years ago, antibiotics revolutionized medicine. Bacterial infections wreaked havoc and the appearance of substances capable of annihilating microbes led to an unprecedented improvement in life expectancy. Since then, the massive, and sometimes negligent, use of antibiotics has allowed bacteria to adapt to their attacks and resistance threatens to devalue medicines that have saved millions of lives. Now, the study of the intestinal microbiota, an ecosystem of microorganisms that coexist inside us in a complex balance, is making new treatments for infections possible.
This is the case of MBK-01, the code name of a drug to treat infection by Clostridium difficile, which affects 124,000 hospitalized people in Europe every year. The drug is a pill made from feces from healthy donors that manages to combat the bacteria with a method different from the antibiotic. Instead of killing the organism that causes diarrhea, and along with it many others that are necessary for good intestinal health, it introduces the balanced microbiota of a healthy patient. All those beneficial organisms, like foxes that quell a rabbit infestation, counteract the excess of C. difficile and restore health without destroying the bacterial ecosystem, something that makes relapses easier later.
The drug, developed by a small company from Derio (Vizcaya, Spain) called Mikrobiomik, has passed a phase 3 trial, the last in humans before approval, with positive results. In this study, in which 92 patients from 21 centers in Spain with infection of C. difficile, no safety problems have been detected and an effectiveness 15% higher than fidaxomicin, the antibiotic usually used for these infections, has been observed. In addition, it also showed that people who took the stool pill had a lower recurrence than those who received the antibiotic.
In the United States, two microbiota therapies are already marketed for similar infections, one developed by Seres Therapeutics, which was the first approved oral fecal microbiota transplant in the world, and another developed by Rebiotix that is introduced by colonoscopy. In both cases, the FDA, the body that regulates the use of drugs in the United States, approved their use for people with an infection. C. difficile, but only for those who had already suffered relapses after taking antibiotics. The assay developed by Mikrobiomik would allow it to be used as a first option. “It is the first non-antibiotic antibiotic,” summarizes Juan Basterra, CEO of the company.
The C. difficile It is a difficult bacteria to kill. The bacillus forms spores capable of surviving for years in water or on the floor of a hospital, waiting for the right moment to find a host where it can thrive. In the body, the same thing happens. Even if the antibiotic wipes out the bacterial community, the spores can resist and cause a relapse. “In a work published in 2013 in The New England Journal of Medicine It was shown that to combat C. difficile“Better than eliminating it with antibiotics, it was to separate it, make it become subdominant,” explains Francisco Guarner, digestologist and member of the scientific committee of the International Human Microbiome Consortium. “The problem with transplant is that you put in a lot of unknown things, and [en 2019] One person died and another became very ill from one of these transplants. This generated alarm and drew attention to the need to solve the security problem well,” he adds.
Freeze-dried fecal microbiota transplant, in pill format, “could revolutionize access and convenience for the treatment of infections of C. difficile” says Majdi Osman, a professor at Harvard University and medical director of OpenBiome, an organization working to improve the accessibility and safety of fecal microbiota transplants. For Osman, if the product is effective, a capsule would make the treatment easier, in addition to the method of administration, because it could be stored at room temperature. However, the professor also points out that, for the most serious cases, administration by colonoscopy “continues to be more effective” than pills. Even so, Osman points out that “in people with serious infections, who may need several treatments, there may be an initial role for treatment with colonoscopy and then doing the following by oral capsule.” “More research is needed to understand the best route and the best dose,” he concludes.
“After completing this phase 3 trial we are already very close to the market. The EMA (European Medicines Agency) has already classified our product as an active substance,” he points out. In Spain, in addition to the participants in the company’s clinical trials, 40 people have already benefited from the medicine, within the compassionate use of medicines program of the Spanish Agency for Medicines and Health Products (AEMPS), which allows the use of a drug for people who need it, even if it is not approved and the patient is not in a clinical trial. Now, Microbiomik is looking for capital to expand its production capacity and workforce.
For the future, at Mikrobiomik they are testing their technology in diseases of the liver, intestine and as an aid in the treatment of colon cancer. Although the field of research is relatively recent, there are already indications that stool transplants could be useful for treating depression and the relationship between the microbiome and some cardiovascular or degenerative diseases has been seen. After the revolution that improved the lives of millions by killing bad microbes, a new transformation may be underway thanks to pills that restore health by helping good microbes.
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