Dr. Juan Basterra, CEO and Co-FounderClostridioides difficile infection affects approximately 500,000 patients annually in the United States, of these around 30,000 will die. CDI carries significant burdens including clinical, social, and economic. While healthcareassociated CDI has declined in recent years, community-associated CDI is on the rise. Many patients are also impacted by recurrent Clostridioides difficile infection (rCDI); up to 35 percent of index CDI will recur and of these up to 60 percent will further recur with multiple recurrences observed. The most important risk factor for CDI is the use of antibiotics, considering that 60 percent of the cases had taken antibiotics in the 4 months before infection.
Recently NICE has recommended fecal microbiota transplant (FMT) to people who have been treated for two or more Clostridioides difficile infection (CDI) without success. Use of this treatment will also help reduce the reliance on antibiotics and in turn reduce the chances of antimicrobial resistance, which supports NICE’s guidance on good antimicrobial stewardship. Modelling shows that FMT treatment is cheaper than treatment with almost all antibiotics. It saves £769 compared with vancomycin taper pulse (VTP) if FMT is given using colonoscopy. And saves £8,297 compared with vancomycin if it’s given using an oral capsule.
Mikrobiomik is a biopharmaceutical company dedicated to the research, development and production of medicines based on the human microbiome. Mikrobiomik Healthcare Company arrives as a panacea for human gut health with microbiome-based treatment intestinal microbiota transference. Its first investigational biological medicine, MBK-01 is a next-gen innovative intestinal microbiota capsule, which promises to provide safe and effective treatment for restoring the intestinal health of C. diff patients.
“Mikrobiomik aims to be the first company worldwide to market in the European Union the first oral biological medicine based on intestinal microbiota in the indication of primary or recurrent Clostridioides difficile infection, through the administration of 4 capsules with FSPIM (Full Spectrum & Purified Intestinal Microbiota) technology in a single dose,” says Dr. Juan Basterra, CEO, and co-founder of Mikrobiomik Healthcare Company.
Drawing from decades of experience in the healthcare industry, Dr. Basterra is pioneering the research and development of revolutionary biological medicines in the microbiome therapeutic space. His foresight to develop a unique treatment option for saving numerous lives against serious chronic ailments led to the genesis of Mikrobiomik.
Mikrobiomik will publish the results of its Phase III trial in the indication of primary or recurrent Clostridioides difficile infection at the end of 2023, after obtaining encouraging intermediate results in its comparison with the standard of care, the antibiotic Fidaxomicin, and is currently in talks with the EMA (European Medicines Agency) with the aim of applying for registration and subsequent marketing authorization for MBK-01 through the centralized route. The AEMPS (Spanish Agency for Medicines and Health Products) has authorized 20 compassionate uses for the supply to patients who could not be included in the phase III trial, but who have no therapeutic alternative after having failed all the treatments tried, a compassionate use that Mikrobiomik supplies to the hospital in a completely altruistic manner.
Mikrobiomik plans to launch its first investigational medicine, MBK-01, in the first half of 2025, making it the world's first oral gut microbiota-based biological medicine for the treatment of primary or recurrent Clostridioides difficile infection through the administration of a single dose of 4 capsules with FSPIM (Full Spectrum & Purified Intestinal Microbiota) technology.
Qualifying an Ideal Stool Donor
Choosing a donor for fecal microbiota transplantations is a crucial step. Mikrobiomik’s robust and efficient donor selection process involves three major phases of screening, including an online health questionnaire, medical interview and blood and stool tests in line with European guidelines. Its expert medical team evaluates whether a person has valid grounds to donate and approves based on the initial phase of the application. The next phase is comprehensive and in-depth, with one hour interview seeking the candidate’s complete family history and personal health information. Finally, numerous blood and stool tests are carried out as well as a nasopharyngeal PCR, before and after making donations, updating the screening with the latest developments such as the incorporation of the detection of monkeypox virus. Ultimately, a person is certified to be a donor to make between two and five donations a week for a maximum of two months.
The goal is to have faithful, healthy donors with absolute transparency to ensure Mikrobiomik always contributes to the safety of patients.
Above all, Mikrobiomik is committed to advising donors on all aspects of maintaining a healthy diet during the donation period and avoiding excess fat, smoking, and alcohol consumption.
“We breathe innovation and have the willingness to push the boundaries of human limitations in the fight against both acute and chronic diseases without therapeutic alternatives,” states Basterra.
Clinical research is the DNA of Mikrobiomik’s culture. Its small, multidisciplinary team of pharmaceutical, biochemical, and medical experts and top scientific minds is determined to make the development of MBK-01 a success.
Apart from C. diff infections, Mikrobiomik will launch new clinical trials in 2023, including a Phase II vs placebo trial in the indication of non-alcoholic steatohepatitis, as well as a proof-of-concept trial in metastatic cancers of the stomach, colon and pancreas that do not respond to 2-3 lines of treatment.
Mikrobiomik aims to be the first company worldwide to market in the European Union the first oral biological medicine based on intestinal microbiota in the indication of primary or recurrent Clostridioides difficile infection, through the administration of 4 capsules with FSPIM (Full Spectrum & Purified Intestinal Microbiota) technology in a single dose
Charting New Clinical Milestones
Powering its pharmaceutical production of its state-ofthe-art manufacturing facility, Mikrobiomik has the only GMP (Good Manufacturing Practices) facility certified at European level by a regulatory agency (AEMPS, Spanish Agency of Medicines and Health Products) which allows it to distribute its first investigational biological medicine, MBK-01, for use in clinical trials.
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We breathe innovation and have the willingness to push the boundaries of human limitations in the fight against both acute and chronic diseases without therapeutic alternatives
Aiming to expand its in-house manufacturing capabilities, it plans to construct a new industrial plant. This will enable it to accelerate clinical trials and manufacture products on a large scale.
Leveraging its resilient development pipeline and scientific underpinnings, the coming years will be a defining period for Mikrobiomik, as it leads a paradigm shift in the microbiome landscape—giving C. diff patients a new lease on life.
