Thank you for your interest in learning more about our ongoing clinical trials. Below we’ve included information on our technology as well as details about how you can learn more about clinician and patient participation in clinical trials.
What is the microbiome’s role in human health?
Discoveries made over the past decade have radically reshaped clinical understanding of the role that the human microbiome plays in regulating 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.
Seres is leading a paradigm shift in the understanding and treatment of human diseases that result from functional deficiencies of the human microbiome, a condition known as dysbiosis. We believe the microbiome holds great promise for patients whose conditions are not served by current approaches.
How does this new approach to treating disease work?
Rather than take aim at traditional disease targets, our microbiome therapeutics platform is designed to find and fix functional deficiencies that derive from a disrupted microbiome and that that give rise to a given disease. Early data from our lead clinical program in recurrent C. difficile infection suggests that this approach can lead to unprecedented clinical efficacy. Our proprietary discovery and design platform enables us to elucidate how changes in the composition of microbes in a disrupted dysbiotic microbiome relate to alterations in the metabolic and immunological function of the microbiome, and to design and empirically optimize Ecobiotic® drugs that disrupt the diseased microbiome and catalyze the repair of the microbiome, improving health.
Our current clinical disease targets
Clostridium difficile infection (CDI)
Clostridium difficile is a bacteria that can cause unpleasant and sometimes serious symptoms, including diarrhea and stomach pain. CDI is the most common cause of hospital acquired infection in the U.S. and is responsible for the death of approximately 29,000 Americans each year. The risk of recurrence is approximately 25 percent after the primary occurrence, 40 percent after a first recurrence, and more than 60 percent for those who have experienced two or more recurrences.
Ulcerative colitis (UC)
We are currently evaluating SER-287 in patients with mild-to-moderate UC, a serious chronic condition affecting approximately 700,000 individuals in the United States. The disease results in inflammation of the colon and rectum and can result in debilitating symptoms, including abdominal pain, bowel urgency and diarrhea.
Our current clinical trials
Below is a list of the clinical trials we currently have in progress. By clicking on the link, you will be redirected to the page on our website with more information on the clinical trial and how your patients may be able to participate.
- SER-109 (ECOSPOR III): A Phase 3 study (ECOSPOR III) to evaluate the safety and efficacy of SER-109 versus placebo. ECOSPOR III incorporates direct learnings from prior SER-109 development efforts. The study is expected to enroll approximately 320 patients with multiply recurrent C. difficile infection, randomized 1:1 to either SER-109 or placebo. The study is sized to contribute to an adequate safety database that may support product licensure. ECOSPOR III will utilize more than 100 clinical sites across the U.S. and Canada. The study’s primary endpoint will compare the reduction of C. difficile recurrence rates in subjects who receive SER-109 verses placebo at up to eight weeks after dosing.
- SER-287, SERES-101 Study: A current Phase 1b clinical study evaluating the safety and efficacy of SER-287 versus placebo, in adults with mild-to-moderate ulcerative colitis (UC) (SERES-101)
- SER-262, SERES-001 Study: A current Phase 1b study evaluating the safety and efficacy of SER-262 versus placebo, in adults with primary Clostridium difficile infection to prevent recurrence (SER-262)
If you have patients you think may qualify for this clinical trial or if you would like to be involved as a clinical trial site, please contact us at 617.945.9626 x304.