Microbiome refers to the collection of microbes and their interaction with the human body.  Human body possess a number of different species, particularly bacteria and fungi, which help in digesting food, preventing infections, perform numerous life-supporting tasks. Microbiome and metagenome have important functions in health and disease of the human individual and their exploration will help open up the vast ocean of information in human genetics. Microbiota plays an important role in food digestion, release of vitamins but at the same time, they cause various ailments such as metabolic disorders like diarrhoea, obesity, diabetes etc. Studies have shown tumor-promoting effects of the microbiota in skin, colon, liver, breast and lungs and a process called bacterial dysbiosis is a potential risk factor in the pathogenesis of cardiovascular diseases.

There are various microbiome projects that are underway such as The Human Microbiome Project, American Gut Project and Canadian Microbiome Initiative (CMI). Majority of the companies are focusing on three major therapy areas which are Gastrointestinal, Infectious Disease and Metabolic Syndrome, and are collaborating with research organizations, universities and other companies for the development of the drugs. It has been observed that these collaborations have increased greatly in 2016.

The microbiome drug development is majorly making use of MiNE (Microbiome isolates and Novel Extracts) platform of Quorum Innovations. RBX2660 is the major drug candidate that has received Ophan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation from the US FDA. The company is now working with the FDA to finalise the protocol for a randomised multicenter Phase III study of the drug. This drug is followed by SER-109 from Seres Therapeutics holding Orphan and Fast Track Designation. RBX2660 from Ritter Pharmaceuticals also possesses the potential to become the first FDA-approved the drug for treatment of lactose intolerance. Additionally, ribaxamase  from Synthetic Biologics can be used with IV beta-lactam antibiotics and Phase III trials are targeted for second half of 2016.

There are some unmet needs to determine the diversity of microbiome as the interpretation of the exact diversity of the microbiome as the biomarker for the diagnosis of the disease is to be established. There are no approved microbiome drugs available on the market yet, so due to this, many companies are racing to develop new drugs. Researchers still need to unveil that how microbiome communicates with the central nervous system and thus influences the brain function. Microbiome, if well understood, can be used as personalised medicine which can be tailor made according to the patient’s need. Microbes have the capability to adapt themselves as per their surroundings and it has been found that based on the gut environment the microbes and the community changes from time to time. With proper monitoring and culturing of the microbial flora, we can anticipate that the diagnosis of many diseases will be much more prompt and timely and accordingly this will help in designing a proper treatment strategy for conditions that have been proved untreatable with conventional methods.

Insight By:
Anurag Mathur
Associate Analyst