Seres Therapeutics

Founded by Flagship Pioneering in 2011, Seres Therapeutics (NASDAQ: MCRB) is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the state of bacterial diversity and function is imbalanced. The company’s Ecobiotic^® drugs are targeted to help restore the complex underlying ecology and function of a healthy human microbiome.

The Microbiome: A Central Mediator of Health

Discoveries made over the past decade—catalyzed by major investments in the Human Microbiome Project, the Metagenomics Project of the Human Intestinal Tract, and other research efforts—have rapidly advanced our understanding of the role that the human microbiome plays in modulating human health.

Once seen only in adversarial terms, today the trillions of bacteria that inhabit or live on our bodies are known to play important, beneficial roles in a wide range of biological processes, including resistance to pathogens, regulation of immune function, and energy metabolism.

What we’ve learned from studying the human microbiome is that there is no one universal “healthy” or “diseased” microbiome. In fact, we know from the Human Microbiome Project that there is great diversity in the microbiomes of healthy individuals. This diversity could prove daunting in terms of identifying targets and developing new medicines to treat disease, but early research published in journals like Nature and Science has shown that within this huge array of unique microbial ecosystems there are key functional properties of microbial ecologies that can define states of health and states of disease.

Product Pipeline

Seres Therapeutics’ proprietary discovery and design platform enables the company to identify key alterations in the microbiome that are associated with or lead to specific diseases and to rationally design tailored therapies that disrupt the disease state and establish a healthy microbiome.

The company’s lead Phase 3 development candidate, SER-109, is an investigational oral microbiome therapeutic for the prevention of Clostridium difficile infection (CDI) in adults with multiply recurrent CDI. The FDA has designated SER-109 as both a Breakthrough Therapy and an Orphan Drug.

The company is currently evaluating SER-262, the first synthetically-derived and designed microbiome therapeutic ever to reach clinical-stage development, in a Phase 1b study in patients with primary Clostridium difficile infection.

Seres is developing Ecobiotic® drugs to treat inflammatory bowel disease, including Ulcerative Colitis (UC) and reported positive results of the company’s Phase 1b study of SER-287 in patients with ulcerative colitis.

In addition, Seres is developing SER-401, a preclinical stage oral microbiome therapy comprising a rationally-designed consortium of live bacteria, to improve the efficacy and safety of immunotherapy. Through a collaboration with The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, Seres is initiating a randomized, placebo-controlled clinical study in patients with advanced metastatic melanoma.

Seres is also researching the use of Ecobiotic® drugs for the treatment of additional inflammatory diseases and metabolic diseases.