Human microbiome therapeutics is still in its infancy compared to more established next generation fields. That brings with it a lot of excitement, but also a lot of uncertainty about what the future holds for the industry and where the big breakthroughs are going to come. We asked seven industry experts where they see the microbiome therapeutics industry going in the next five years and which areas hold the most promise.
Mark Smith, CEO, Finch Therapeutics
‘During the next five years, I believe therapies that deliver complete microbial communities will continue to dominate the field of microbial therapies. These treatments, derived from healthy donors much like immunoglobulins and other blood products are derived from donors, enable the full microbial community of a patient to be reset with a single intervention. Donor derived complete microbial therapies are already in widespread clinical use today, and over 45,000 Clostridium difficile patients have been treated with this approach. Finch has invested heavily in the complete microbial community approach, with an ongoing, potentially pivotal Phase 2 study testing CP101, our oral full-spectrum microbiota product for recurrent Clostridium difficile infections.
As our understanding of this complex ecosystem deepens, I believe the field will follow a trajectory of reductionism, with the next step being translation from entire communities down to consortia of key organisms that can be grown in pure culture. Finch is a pioneer in this approach, working with Takeda to create a defined microbial consortia for the treatment of inflammatory bowel disease that is informed and significantly de-risked by several successful clinical trials using complete community microbial therapies. I believe both complete community and select consortia approaches will be critical to the field, with the community approach being most relevant clinically and commercially over the next five years.’
Mark Smith is speaking at Microbiome Therapeutics US on 'VCs vs Pharma: changing landscape of funding models' in Boston on 11 September.
Dr Chengwei Luo, CEO, DeepBiome Therapeutics
‘The past 5 years we have accumulated a lot of data and observation on how microbiome is associated with certain types of health aspects; but it remains mostly unknown how microbiome-host interaction works at the mechanistic level. The mechanisms can be through some molecules that the microbes make, or some antigens the bugs present to the host immune system. I think understanding these aspects and deriving therapeutics from those understandings really holds a lot of promise.’
Dr Chengwei Luo is speaking at Microbiome Therapeutics US on 'Unleashing the power of microbiome with AI, Synthetic Biology, and Beyond' in Boston on 10 September.
Jack Gilbert, Professor, Department of Pediatrics and Scripps Institution of Oceanography, University of California San Diego; Author, Dirt is Good - @GilbertJackA
‘Small molecule interventions based on the metabolites that microbes synthesize and that the body senses to regulate transcription and cellular activation are key. These will have the biggest medium-term impact. The key concern is of course, which metabolites - do they act in isolation or as part of a coordinate strategy, and how can we apply them in medicine without the use of probiotics (which may or may not work effectively)? The way a bacterium delivers a metabolite to the body is very different to the ways in which we can deliver the same compounds - what effect does that have on efficacy and dose dependency?’
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Martha Carlin, CEO, The BioCollective
‘I believe that therapeutics in the gut-brain access some of the most promising areas. While IBS/IBD have led the way in early microbiome investment, much has been learned along the way from these early investments. Rapid progress in the understanding of the connections between the gut and the brain holds great promise. We have seen progress in schizophrenia, autism, Parkinson’s, MS, ALS and even Alzheimer’s related to potential pathogens impacting gut and brain chemistry. The microbiome can also provide very specific clinical targets and measurable outcomes that have previously been missing from neurological disease. Additionally, the pathogen hypothesis in Alzheimer’s offers some interesting opportunities for the repurposing of certain antibiotics and greater potential for understanding how an immune system behaves when overloaded with bacterial toxins which may lead to aberrant pathologies.’
Martha Carlin is speaking at Microbiome Therapeutics US on 'Standardizing Microbiomics: Collection, Purification and Analysis' in Boston on 10 September.
Regina Au, Principal, New Product Planning Consultant at BioMarketing Insight
‘I think this field will continue to grow as we further understand the role our microbiome plays in our physiology and diseases. The information that came out of the Human Microbiome Project makes sense along with what researchers have said 20+ years ago regarding skin flora. It has also been confirmed with a number of studies from various institutions like the Broad Institute and major pharmaceutical companies have formed a separate microbiome business unit.
We just don't understand it yet. A good example would be what researchers used to call "Junk DNA" or non-coding DNA. Some of these Junk DNA have now been discovered to play some integral role in the function of cells, particularly the control of gene activity.
There are three areas that will advance the most: 1) the gut (IBS, IBD, colon cancer etc.) where there has been a lot of interest and research; 2) the brain or CNS disorders, the brain-gut axis theory and 3) the immune system. From a research perspective, once these areas are better understood, it will rapidly expand to all other areas because everything is related.
From a therapeutic perspective, the industry has yet to figure out how to achieve symbiosis or restore the appropriate function to our system in becoming healthy. Once researchers figure this out, there will be an explosion of products on the market.’
Regina Au is speaking at Microbiome Therapeutics US on 'Important Early Considerations to Developing a Successful Commercial Strategy' in Boston on 11 September.
Gitte Pedersen, CEO and Co-founder Genomic Expression - @DNABarcode
‘I am biased in this answer as my focus is cancer. It’s very evident that the microbiome plays a significant role in the response to immune therapy check point inhibitors in particular. I believe we will decipher this to being able to use probiotics as an adjuvant therapy to immune therapy and possibly also other cancer therapies, which is exciting because this kind of treatment is so effective.’
Bharat Dixit, VP of Bioprocess and Analytical Development, Finch Therapeutics
‘I think development and progress in the arena of gut-brain axis and modulation of drug metabolism will be very important and play a key role in shaping whole microbiome field.’
Bharat Dixit is speaking at Microbiome Therapeutics US on 'Options & Challenges for Small & large companies; implement your own microbiome division, or buy a company working in the microbiome space?' in Boston on 11 September.