To ensure adequate production quality and to assess the risks and benefits of medicines that treat a disease, drugs must be approved by a regulatory medicines agency before use. This review is particularly important given the vulnerability of the preterm babies. To date no dietary/probiotic product on the market has been approved by these regulatory agencies. IBT is committed to develop the first live bacterial product by following the agency requirements.
Any substance or agent that is to be used with a claim to cure, mitigate, treat or prevent a disease must be approved by medicines agencies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Development and approval involve all aspects of production, pre-clinical and clinical development plans, the safety and efficacy of the medicine in the intended patient population, and continued follow-up after a marketing authorization has been awarded. The regulations are clear, unified and easily available for all to follow, and they are there to safeguard all patients who take the preparations to treat or prevent their disease. In short, if there are probiotic formulations that potentially can influence a disease to the benefit of patients, then these should be developed in accordance with the current drug regulations and approved by the medicines agencies. This path is clear and unequivocal, albeit expensive and time-consuming.
IBT is following this path with the development of its medical drug candidate IBP-9414, through rigorous pharmaceutical Chemistry-Manufacturing-Control standards in all steps with GMP according to 21 CFR Part 210/211, dose accuracy following ICH Guidelines for Pharmaceuticals and stringent control of bioburden and microbial purity on final product analysis according to US and Eur Pharmacopoeia. IBP-9414 is now being tested in Phase 3, under IND in the US and under approved Clinical Trial Exemption (CTX) in Spain, France, UK, Israel and Hungary.
To date, no live bacterial, so-called probiotic therapy has undergone such careful and controlled medicines agency evaluation for use in preterm infants, or indeed any humans, to prevent or treat a disease. Consequently, none of the multitude of probiotic food supplements available are produced by medicines agency approved methods, nor have they been documented and approved as safe and effective for disease treatment or prevention use in any human being. In fact, the FDA has expressed its concern for reported serious side effects and risks on the use of these non-approved probiotics in preterm infants. [1-4]
1. Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans, Published Aug 16, 2018. Accessed Feb 20, 2020.
2. Science and regulation of live microbiome-based products used to prevent, treat, and cure diseases in humans. United States Food and Drug Administration National Institute of Allergy and Infectious Diseases. Accessed Feb 20, 2020
4. Notes from the Field: Fatal Gastrointestinal Mucormycosis in a Premature Infant Associated with a Contaminated Dietary Supplement — Connecticut, 2014. February 20, 2015 / 64(06);155-156. Published Feb 20, 2015. Accessed Feb 14, 2020.