Microbiome is the collection of bacteria, fungi, and other microbes that reside in the gut, on the skin, and within other human tissue. It defines the genome of all the microorganisms, symbiotic and pathogenic, living in humans. Relentless research on the microbiome for the last few years is creating new ways to treat disease. Its dynamic nature is driving impetus and enthusiasm for clinical research. Advances in assessing the microbiome and how it impacts immunity have put the human ability to characterize and maneuver the microbiome within reach.

It is said that the microbiome is the only organ that can be replaced without surgery. As a result, several clinical studies are in progress that are testing single commensals, an assortment of defined species and subspecies, and a combination of microbiota-derived molecules targeting specific microbial species or pathways that are increased or absent in the disease state to treat or ward off a variety of diseases. As microbiomes are the communities of microorganisms that live on or in people, plants, soil, oceans, and the atmosphere, they maintain the healthy function of these different ecosystems, disrupting human health, climate change, food security, and other factors.

Various industrial processes such as biofuel production and food processing rely on healthy microbial communities. Although new technologies have enabled exciting discoveries about the significance of microbiomes, scientists still lack the knowledge and tools to manage microbiomes that prevent dysfunction or restores healthy function.

In May 2016, the White House announced the National Microbiome Initiative with US$121 million in Federal and US$400 million in private funds to encourage the study and use of the microbiome. However, before this initiative, many companies have already taken the concept of the microbiome as a therapeutic to the next stage by developing commercial products. Rebiotix is on such a company that takes a microbiome-based product as a drug through the FDA. Its product for the prevention of recurrent CDI is the most clinically advanced, reports noted.

In the current scenario, wherein the entire world grapples with COVID-19 pandemic, CEO and managing partner of Seventure Partners, Isabelle de Cremoux said that given the number of late-stage and mid-stage studies expected to report data in 2020 – assuming they stay on track amid the COVID-19 pandemic – this could be a pivotal year for the field. According to her, in every new (drug) class there’s always been people that were very skeptic, and thought that it would just be something very short. When they see good data, then they change their minds. In addition, she said, she is sure that will happen in the microbiome field as well.

Clinical trials are expected to generate good safety data because many of these experimental therapies are produced from bacteria already found in the human body, Cremoux said. In many cases, microbiome therapies will complement other treatments for patients, Hervé Affagard, CEO of Lyon, France-based MaaT Pharma said. MaaT Pharma is developing products that restore the microbiome in patients who have received stem cell transplants, antibiotics, or chemotherapy. The company’s MaaT013, an experimental enema-based treatment, is being assessed in two separate mid-stage tests, one for patients with acute graft-versus-host disease and the other in patients with acute myeloid leukemia or myelodysplastic syndromes.

However, microbiome drug development also draws challenges owing to its complex and dynamic state affected by multiple influences. These influences do not only augment the complexity of running a global study where the product is under study that exposed to such inter-subject variability, but there are major intra-individual variabilities too that affect the microbiome.