RESEARCH PROJECT
Hemispheric University
Universidad Andrés Bello
Research Project Title
New formulation for the prevention of recurrent infections caused by Clostridium difficile
Research Project Description
Technical summary: The technology includes a new pharmacological composition with a totally new mechanism of action intended to eliminate germinated spores and vegetative cells of Clostridium diffcile (CD), to treat the recurrence of the infection caused by this bacterium. The combination of the generic components of the formulation inhibits both the internalization of CD spores in the intestine of patients and the triggering of spore germination and, therefore, allows the efficient elimination of the germinated spores as well as the vegetative cells.
Potential impact of the use of the technology: The pharmaceutical composition allows to control at least 50% of the episodes of recurrence associated with the infection, since spores are attacked, unlike the traditional treatment based on antibiotics, which only act at the level of the vegetative cells. Likewise, the potential drug could be manufactured and administered in different modalities, including encapsulated in nanoparticles, allowing it to be delivered to specific areas in the body and also released in a controlled manner. Additionally, it should be noted that all the constituents of the composition are already approved by the FDA, which reduces the risk and cost involved in developing a drug by simplifying toxicology and safety studies.
Market: The global market size for infections caused by C. difficile was estimated at approximately US $ 630 million in 2016 and is projected to reach around 1.7 billion in 2026, representing a compound annual growth rate of 10.2%. Market growth will occur mainly in countries such as the United States, France, Germany, Italy, Spain, the United Kingdom and Japan, due to the arrival of specific antibiotics for ICD treatment as well as alternative therapies to prevent recurrence5. Currently, DIFICID, also known as fidaxomicin, is a drug approved to treat diarrhea caused by Clostridium difficile, which is sold by Merck and focuses on both the treatment of the infection and the prevention of recurrence. However, its massive use is threatened by its high cost and by the presence of other generic antibiotics in the market6. It is expected that Merck lead the market until its competitors launch some of the products that are in the phases of clinical studies. The products under study can be classified into: vaccines, antibodies, new antibiotics and systems capable of restoring and protecting the normal flora (microbiome therapy).