Juan Basterra, CEO of Mikrobiomik, has been interviewed for the CEBEK (Bizkaia Business Confederation) magazine.
What does Mikrobiomik do? What is your goal?
Mikrobiomik is a biopharmaceutical start-up, created to research, develop, produce and market, biological medicines based on the human microbiome. Mikrobiomik is made up of a multidisciplinary and expert team of doctors, pharmacists and biochemists, all specialists in the world of the human microbiome.
Mikrobiomik aspires to be the first company worldwide to market in Europe the first biological medicine to treat infection by clostridiodes difficile, in the innovative format of faecal microbiota lyophilized capsules to be administered orally.
We understand that human faeces is the starting raw material for Mikrobiomik.
Indeed, we use faeces and an innovative technology process to isolate and purify the microbiota. It is finally transformed into a 250-mg capsule. We need to be aware that something as simple as donating faeces can save many lives, as is the case of patients suffering from multiple recurrences of clostridioides difficile which, in some cases, can prove to be fatal.
How does Mikrobiomik select its faeces donors? What does one need to do to be a faeces donor? Are the donors paid?
A biological medicine requires the highest safety standards and manufacturing and clinical good practice standards, from controlling the raw material to the health authorities approving the final product. Mikrobiomik requires its potential donors to complete an initial questionnaire, followed by an in-depth medical interview and the relevant blood, faeces and nose & throat PCR tests. Only after they have successfully completed these three phrases are the donors approved and can begin to donate. Our aim is to always have “loyal healthy donors”, who are willing to make a minimum of 2 donations a week, for two months. Mikrobiomik makes a financial payment for each valid donation, in order to cover the donor’s travel costs, as donations are made at our facilities located at the Derío Technology Park. The steps to become a donor are explained in a straightforward way at this video.
A new generation of medicines. Are they created here?
Mikrobiomik signed a know-how and technology transfer agreement FIBHGM (Biomedical Research Foundation of the Gregorio Marañón Hospital in Madrid). According to which, the ground-breaking centre in Faecal Microbiota Transplantation (FMT) in Spain transferred to Mikrobiomik, on an exclusive basis, the knowledge and expertise accumulated during over 5 years at the Gregorio Marañón’s Clinical Microbiology Service, a trail-blazer in the treatment of recurrent clostridioides difficile using the aforementioned technique. Mikrobiomik has the first and only GMP (Good Manufacturing Practices) facility exclusively used to manufacturing biological medicines arising from intestinal microbiota; an innovative technological process transforms the initial faeces sample into intestinal microbiota capsules to be administered orally.
What are the target conditions?
Our mission is to save lives. Therefore, our first investigational medicine, MBK-01, will soon begin Phase 3, the last phase prior to its being launched on the market. It is aimed at treating recurrent clostridioides difficile (CDI), the main cause of diarrhoea suffered by hospitalised patients and also of 20% of the cases of diarrhoea and colitis associated to the use of antibiotics. In the USA alone, there are over 500,000 episodes of CDI a year, which are responsible for over 30,000 deaths and generate a health overrun of around $2 billion. 75% of CDI patients respond to the standard antibiotic treatment, vancomycin, but 25% present multiple recurrences that may lead to their death. In those patients, FMT has shown efficiency ratios of over 90% without relevant secondary effects. It is endorsed by the leading guidelines worldwide as one of the most efficient therapeutical options and with greater degree of evidence to treat recurrent CDI. Next year, Mikrobiomik plans to embark on two new Phase 2 clinical trials, in two new pathologies, non-alcoholic fatty liver disease (non-alcoholic steatohepatitis) and intestinal decolonization by klebsiella pneumonie carbapenem-resistant bacteria (bacteria resistant to antibiotics). In 2021, we intend to start a new immuno-oncology clinical trial.
Are other companies doing the same?
There is no other medicine on the market based on intestinal microbiota in the world, as it is an emerging market that is basically in clinical development. While there are a couple of companies in the USA with microbiota-based medicines in the development phase, in Europe, Mikrobiomik is going to lead the first Phase 3 clinical trial, with advice and input from the AEMPS (Spanish Agency of Medicines and Medical Devices).
What are you working on now?
In the first quarter of the coming year, we want to run our Phase 3 clinical trial in 15 hospitals throughout Spain, once our production facilities have been GMP (Good Manufacturing Practices) certified.
How is Covid-19 affecting you?
Covid-19 is directly impacting the clinical development of investigational medicines. Clinical trials underway in hospitals have been practically suspended, as our health professionals had had to prioritise purely care work due to this terrible pandemic.
And if somebody wishes to become a faeces donor, what do they have to do? They just have to email us at firstname.lastname@example.org, putting “I WANT TO SAVE LIVES” as the subject, and include a telephone number and their name and surname(s). The Mikrobiomik medical team will contact them and ask them to fill in a short health survey online in order to assess whether the candidate is suitable to move on to the new stage of the application process, the medical interview.