Photo by Elena Mozhvilo on Unsplash
Last month marked an important step for microbiome science: Cambridge, MA-based biotechnology company Seres Therapeutics reported positive results from their Phase III human clinical trial of an oral microbiome therapeutic for the treatment of recurrent C. difficile infection. Assuming nothing catastrophic happens between now and FDA review, the world will soon see its first approved microbiome drug.
This validation that the microbiome can be directly relevant for the treatment of a human condition caps nearly two decades of intensive research on the role of commensal bacteria in health and disease. Over those twenty some odd years we've learned not only what types of bacteria live with us, but how those bacteria alter our immune and nervous systems, how they change in response to diet and geography, and even how individual strains of bacteria contribute to diseases as far-ranging as cancer and ALS.
Given that the microbiome is a core focus area of our investments, we thought now might be a good time to take a closer look at how some of our portfolio companies are capitalizing on our increased understanding of all things microbial.
Thryve Inside
We are quickly coming to an era of personalized microbial products, mirroring an overall trend towards individual health and happiness. As better tools have been developed to take a snapshot of an individual's microbiome, companies like Thryve Inside are paving the way for anyone to track the overall health and status of their gut from the comfort of their homes. Thryve acknowledges that every gut is different and that tailored solutions are not only beneficial but necessary. To back themselves up scientifically, they leverage natural language processing and machine learning to summarize over 50,000 research papers on the microbiome. Taking and condensing these insights, the company has created the world’s first customized solution to target gut health by combining a microbiome DNA test, a digital app with health reports and customized food plants, and personalized probiotics.
Mybacs
The microbiome doesn't just alter your gut. In fact, it has become increasingly clear that the effects of the microbiome extend to most, if not all, of the major systems in our bodies. Perhaps the most well studied is the link between the microbiome and our immune systems, where the complex interplay between the two can alter the balance between health and disease. Mybacs has developed synbiotics, which are combinations of pre and probiotics along with essential vitamins and minerals, that can support immune function along with a range of other bodily systems. The company further individualizes their synbiotics with formulations specifically designed for women, men, and children.
Solarea Bio
Solarea Bio is developing a microbiome-based solution for musculoskeletal and inflammatory conditions. They implemented computational tools and infrastructure to predict microbial interactions. They are now entering a clinical proof of concept and plan to commercialize the first product in a couple of years.
Bloom Science
Seres Therapeutics might be close to marketing the first microbiome therapeutic, but we believe this is only the beginning of bacterial drugs. Bloom Science was launched with the unique insight that changes to the microbiome can actually mimic the effects of a ketogenic diet. Since at least the 1920s it has been observed that a ketogenic diet (high fat, low carb) can help control refractory epilepsy in both children and adults. Amazingly, the founders of Bloom discovered that a single bacterial species could protect against seizures in preclinical studies. The company is now rapidly expanding its platform and potential indications to include a range of neurological and immunological disorders.
DermBiont
With so much emphasis on the gut, we often forget that bacteria ––for better or for worse –– also live on our skin. DermBiont is a clinical-stage biotech company developing topical live bacterial products, first for the treatment of fungal skin diseases. The company is underpinned by a bioinformatic platform that identifies the alterations in the skin microbiome (dysbiosis) that underlie many common skin conditions. Once those sources of dysbiosis are understood, they can then develop a specific set of microbes to restore the bacterial balance of the skin and treat the underlying condition. Dermbiont recently announced positive results from their Phase 2a clinical trial of their lead candidate DBI-001 for the treatment of interdigital tinea pedis, otherwise known as athlete's foot. They reported no adverse events from the treatment and will move towards a Phase 2b trial later this year.
Looking ahead
There are likely at least as many bacterial cells in our bodies as there are human cells. We are exposed to our first microbes at birth and are thereafter fundamentally, inextricably linked to our microbiome. We are just beginning to comprehend the myriad ways in which this relationship alters our health. From our viewpoint, the next generation of microbiome technology will focus increasingly on the products that microbes themselves make. Methods of discovering, detecting, and assaying those products will be needed. As we refine our understanding of individual strains of bacteria, so too will we need precision methods to add, delete, or modify those strains.
Personalization will come into full focus as it has in other areas of medicine. The types of bacteria that benefit or harm you will depend on your genetics, your immune system, the rest of your microbiome, and other aspects of your environment. But most of all we continue to believe, as we have for some time now, that the microbiome has a central role to play in all dimensions of our health and happiness. Are microbes the missing link in certain idiopathic diseases? Do they alter the process of aging and our lifespans? Do they have the capacity to change our senses and moods and desires?
We look forward to finding out.
By Investment Partner Michio Painter and Principal Emi Gonzalez
Where We Are Investing Now: Microbiome
Where We Are Investing Now: HealthTech
Where We Are Investing Now: Longevity and Aging Economy