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SER-287 (SERES-101 study)

SERES-101 is 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), which is currently enrolling at sites in the United States. This study is called a Phase 1b study because it is primarily intended to assess the safety and tolerability of SER-287 when taken by adults, but it will also attempt to identify preliminary signs of efficacy in patients with UC. The full name of the clinical study is: “A Phase 1b Multiple Dose Study to Evaluate the Safety, Tolerability, and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.”

About Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory condition of the colon, leading to episodes of bloody diarrhea and urgency. The disease mostly affects young and middle-aged individuals. The cause of ulcerative colitis is largely unknown. While genetic factors contribute to disease risk, an abnormal relationship between the immune system and intestinal bacteria may also play a role in triggering the disease.

In several previously reported studies, some UC patients with mild-to-moderate disease administered bacteria through fecal microbiota transplant from a healthy donor experienced improvements in their UC symptoms, suggesting that changes in the bacteria may contribute to this clinical response.

About the SERES-101 Study

This study involves research about SER-287 (an investigational medicine). SER-287 is a preparation of bacterial spores highly purified from stool donations obtained from healthy, screened donors and put into capsules. These bacterial spores are inactive forms of the normal bacteria that live in a healthy intestine. SER-287 is a new investigational drug treatment being studied to determine if providing normal healthy bacteria (via SER-287) to UC patients with active symptoms can help restore the balance of bacteria in their intestines and control disease activity.

This study is being done to look at the effects of SER-287 compared to a placebo (a capsule containing no active drug), in treating active UC. This study will also see if giving the antibiotic vancomycin before starting treatment with SER-287 can improve the effect of SER-287. Samples will be collected throughout the study to see the impact of SER-287 compared to placebo on the intestinal bacteria of patients in the study.

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