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C. Difficile Infection Tested with Synthetic Gut Microbe

C. difficile bacteria

Yellow-green fluorescence of C. difficile bacteria (Centers for Disease Control and Prevention)

20 June 2016. A biotechnology company reported results from tests in mice of a synthetic treatment derived from gut microbes that prevents recurrence of Clostridium difficile or C. difficile infections, caused by bacteria often contracted in hospitals or clinics. A team from Seres Therapeutics in Cambridge, Massachusetts presented the findings in a poster session on Saturday at a meeting of American Society for Microbiology in Boston.

According to Centers for Disease Control and Prevention, almost a half-million C. difficile infections occurred in the U.S. in 2011, leading to 29,000 deaths within 30 days of diagnosis. The infections are often contracted in health care facilities, such as clinics and hospitals, causing inflammation in the colon, and symptoms including watery diarrhea, abdominal pain, nausea, loss of appetite, and fever. People who have other illnesses or conditions requiring prolonged use of antibiotics, and the elderly, are at greater risk of this disease.

Seres Therapeutics discovers and develops therapies related to disruptions in the microbiome, the complex aggregate community of diverse intestinal microbes associated with a wide range of health conditions. These disruptions to the microbiome known as dysbiosis  — resulting from pathogens, antibiotics, diet, or inflammation — are increasingly connected or contribute to many chronic and degenerative diseases.

The company’s technology is based on a library of some 9,000 microbial strains collected from healthy human donors. From this library, Seres uses computational techniques to identify microbial communities in the gut associated with healthy and diseased states, then zeroes-in on specific microorganisms, which in the right combinations, can restore healthy functions in the gut from a state of dysbiosis. The company purifies these target microbial combinations into therapy candidates for testing in lab cultures and animals, and later in clinical trials.

The new data report on a synthetic treatment for C. difficile that Seres code-names SER-262 and calls a second-generation therapy for microbiome disruptions. SER-262 is designed to prevent recurrences of C. difficile infections that the company says happens in about a quarter of cases, resulting from damage to the microbiome in dysbiosis. SER-262 is derived through fermentation from strains of microbes similar to the company’s lead product SER-109, an earlier treatment for C. difficile infections now in clinical trials.

In the poster, the Seres team described the process of deriving and distilling the more than 100 candidate bacterial strains for their relatedness to SER-109 and spore-forming potential, as well as safety. From this original collection, the researchers selected 15 strains from which they fermented SER-262, with a genetic and functional similarity to SER-109. In tests on lab mice induced with C. difficile, the team found SER-262 treatments prevented characteristic symptoms of C. difficile, as well as loss of body weight and death.

Seres considers SER-262 a second-generation microbiome treatment, since it does not require donated human material. The company is developing SER-262 into an oral capsule. David Cook, Seres’s chief scientist, says the company is planning the first clinical trials for SER-262 later in 2016.

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