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at that very early stage, probably within that very first 18 months of life after birth when the newborn is beginning to be populated by these microbes, that the immune system is being educated to respond to some things and to tolerate other things. We’re interested in exploring the role of that early life immune education, [which] could provide insights as to what makes certain individuals more susceptible to autoimmune diseases, and other individuals less susceptible to those diseases.
X: What are the potential advantages of microbiome-based therapies?
MB: There is a real symbiotic relationship [between the microbes and human body] that maintains the right equilibrium [in the body]. If we can reset that equilibrium [after disease throws it out of whack] and bring individuals to that healthy state, there’s possibly less risk of overshooting and causing some of the adverse effects that all drug approaches have. In many cases with drugs, we take a normal human protein and inhibit it in some way, and we may go beyond the threshold, where that inhibition itself is causing some of the adverse effects. I think modulating the microbiome properly could overcome that issue, and basically reset our healthy state without going too far.
X: Given that potential, why hasn’t there been more early-stage investment in the field from VC’s and pharmaceutical companies?
MB: It’s an emerging area. It’s an area that, while the potential is almost overwhelming, is new enough where there is no precedence. Validating the use of a live biotherapeutic as a pharmaceutical product hasn’t been done before. So from an investment perspective for a startup, it’s likely that people are waiting for the first one to cross the line before the money then becomes available. There’s probably been that “wait and see” [approach]. Although, I’d say that since we’ve made our first couple of investments in biotechs, as well as several academic collaborations, we’ve noticed a new interest in the field over the last year and a half to two years. Several venture groups are beginning to support their own microbiome projects, as highlighted with the [$10 million Series B] investment announced in Seres [in June] and several other biotechs that were able to raise Series A funding. That investment is beginning to open up. I would expect much more as the data start coming out from this first generation of organizations—if it is positive, of course.
X: Where is microbiome research at right now, and what’s the next step?
MB: Certainly over the last several years if you just look at the number of publications, the field is making a lot of progress. But most of the evidence thus far is [finding that certain bacteria are associated with health or illness rather than proving that changing the microbiome will improve health]. I think the key transition point for us as pharmaceutical organizations interested in developing novel therapies is to take it from that associative data into conducting the proper studies to show cause-effect relationships that then enable insights into mechanisms [of action]. In different areas of the field, that transition is happening. We’re seeing that early data beginning to be generated in the broader field of gastrointestinal health. In metabolic diseases, there have been studies done that show that the way food is metabolized and how the [microbes] in the gut play a role in that has some real impact in how we metabolize food, obtain calories, metabolize fat and so on. These are the two front-running fields where the cause-effect relationships are now being established. [And] in the respiratory arena, studies are showing a correlation between early age exposure to environmental factors related to the microbiome, and the potential to develop allergic diseases and more severe incidence of asthma.
X: What are some of the biggest hurdles the early innovators in this field have to overcome?
MB: Individual organizations, [like Vedanta and Seres], are probing one fundamental question: can a live biotherapeutic actually have … Next Page »