Microbiota Modulation Biotech
Microbiota, microbiome, and microbial imbalance
Every single one of us humans consists of 40 trillion cells that make up our flesh and bones, and an additional 100 trillion of microbial cells. There is an unbelievable diversity of microbes living in our guts, lungs, and skin. The majority of these microbial cells are not alien invaders, they mean us no harm and sometimes even protect us from dangerous diseases and unwanted conditions. We carry these little companions wherever we go, they help us do everything we do, and they can influence our health in many ways. When we see pictures of microbes in biology textbooks, we typically only see either one or two microbes that have been cultivated under special conditions and then photographed under the microscope. In the real world, in actual humans, microbes live in very complex communities of many thousands of different microbial species, otherwise called human microbiota. Scientists differentiate between different types of human microbiota primarily based on their basic habitat, namely gut, vaginal, oral, lung, and skin microbiota.
The activities and functions of human and microbial cells are controlled by their genome, the collection of genes that encode all biochemical processes known as live. While there are only about 22,000 human genes, there are almost 100 times more microbial genes. The Human Genome Project was an international scientific research project aimed at identifying and understanding the functionality of all the genes that make up the human genome. A similar pilot project called Human Microbiome Project was led by NIH between 2008-2013 with the objective to research and characterize the genome of human microbiota, the work that has become possible due to the development of DNA-sequencing methods of genome characterization.
Microbiota is a constellation of microbial communities that we share our bodies with. The healthy balanced microbiota supports our health
Microbiota imbalanceOur clinical trials are expected to start in 2017, immediately once the regulatory approval for human testing is received.
Generally, the microbes with whom we share our bodies, co-exist well with their peer microbes as well as with their hosts (us), and do not cause health troubles. This concerns not only the good bacteria but also the pathogens, the microbes that can potentially harm the host and cause diseases. Exactly like in human communities, when the environment is balanced and controls itself via multiple balance-supporting mechanisms, these potential trouble markers do not have resources and cannot develop behavior that would allow them to critically damage neither the environment nor the community (microbiota) to which they belong. This state of microbial equilibrium between good and bad bacteria could be described as healthy or balanced microbiota. If this delicate balance is broken, the pathogens can dramatically increase in numbers and become dominant. When this quantitative and qualitative shift in favor of microbes that can potentially cause disease is followed by increase in their pathogenic functionality (otherwise known as virulence), their human host might experience symptoms of a disease. This condition in which microbiota shifts from healthy to unhealthy is called dysbiosis.
The Microbiota Modification Revolution
Our technology uniquely allows for a laser-sharp precision of microbiota modification and provides a platform for development of novel topical treatment for a variety of diseases and conditions associated with microbiota imbalance and plagued with high rate of recurrence.
Until recently, only a handful of diseases such as bacterial vaginosis, irritable bowels disease and some diseases of oral mucosa were considered to be linked to the unhealthy shift of microbiota. Recent advances in biological sciences allowed for better understanding of actual composition of microbiota and disease mechanisms in various therapeutic areas, dramatically expanding the list of diseases and conditions associated with microbiota. Emerging scientific data suggests that many more diseases that until recently were not considered to be related to the heath of microbial communities, are in fact associated with the microbial imbalance. The list of these diseases, which is rapidly increasing, now includes such a widespread illness as Plague Psoriasis. What often unites these conditions, particularly those that are treated with anti-infective agents such as antibiotics, is the treatment challenge of a sustained therapeutic effect; a temporary improvement after treatment followed by a swift return of the symptoms of the disease. Now that we learned about the connection between those conditions and microbiota imbalance, this should not be very surprising: in the 100-year old treatment paradigm in which antibiotic drugs are designed to defeat the disease, they act literally as an elephant in a porcelain store, typically hammering target pathogen bacteria along with the broad spectrum of similar bacterial species and only further causing microbial imbalance.
Our patented technology is based on proprietary scientific work in microbiology and colloidal science, which allows us to modify the microbioata towards a healthy state in several conditions associated with dysbiosis across several therapeutic areas. The core difference from available treatments is the ability of our technology to manipulate microbiota in a matter that is supportive to swift restoration of healthy microbial balance, without typical ‘carpet-bombing’ effect of currently available Rx treatments.
Our novel vaginal gel is a non-antibiotic treatment that selectively targets pathogens associated with Bacterial Vaginosis without jeopardizing the survival of the native Lactobacilli
Bacterial Vaginosis is the most common infection of women of childbearing age and a very prominent example of microbiota imbalance. Bacterial Vaginosis is not a life-threatening disease but it is associated with two conditions representing daunting healthcare challenges: with increased risk of HIV transition and, in pregnant women, with increased risk of pre-term birth. Microbiological diagnosis of Bacterial Vaginosis is made based on the identification of excessive growth of anaerobic bacteria and particularly of Gardnerella Vaginalis, and simultaneous diminishing presence of Lactobacillus species that have a protective effect on vaginal microbiota.
The diseases associated with microbiota imbalance tend to be recurrent in nature. Patients often experience fast return of symptoms after the initial post-treatment improvement, and have to go through multiple courses of treatment with various antibiotics, still with limited success. Consistent with the challenge of disease recurrence associated with microbiota imbalance, the treatment of Bacterial Vaginosis with antibiotics, the only Rx drugs globally licensed to treat Bacterial Vaginosis, would typically lead to short-term improvement of symptoms but more than often would be followed by a rapid recurrence of symptoms. This recurrence of symptoms is the result of the return of unbalanced microbiota characteristical with the disease state.
Our lead product is a non-antibiotic novel vaginal gel that selectively targets pathogens associated with Bacterial Vaginosis without jeopardizing the survival of native Lactobacilli. Its active pharmaceutical ingredient is an organic molecule that provides a targeted antimicrobial activity sufficient to control pathogens and to trigger natural modification of vaginal microbiota back to its healthy balanced state. Most importantly, the use of our product helps prevent the carpet-bombing effect of other antibacterial products on vaginal microbiota, hence eliminating conditions promoting the disease recurrence. The pre-clinical testing of our product is in its final stage. The clinical trials are scheduled to start immediately once the regulatory approval for human testing has been received.
Additional LearningDiseases and conditions that can potentially be treated by microbiota modulation technology
- Childhood Allergies
- Imflammatory Bowel Disease, Irritable Bowel disease, Type 2 Diabetis, Obesity, Colorectal Cancer
- Metabolic Syndrome
- Juvenile Idiopathic Arthritis
- Bacterial Vaginosis: treatment and need for innovation
- Womens' Health: antibiotic-sparing strategies to modulate vaginal microbiota