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Microbiome Therapeutic Failes to Outperform a Placebo in Phase II Trial

Accepted submission by Anonymous Coward at 2016-07-29 19:38:13
Science

[The] Centers for Disease Control and Prevention estimates that close to half a million cases still occur in the United States each year. Multiple relapses also remain common, with approximately 30 percent of patients experiencing at least one recurrence two to four weeks after completing standard antibiotic therapy. Patients who have one recurrence are at high risk of multiple additional recurrences, with a 60 percent chance of relapse after the third recurrence. These patients tend to have poor outcomes and present major clinical challenges.

Seres Therapeutics ($MCRB) has suffered a sizable setback to its microbiome R&D ambitions. In a Phase II trial, the oral microbiome therapeutic SER-109 failed to outperform a placebo in terms of cutting the risk of Clostridium difficile infection (CDI), leaving the biotech scraping through the results in search a path forward for the program.

[...] The fallout from the setback could extend well beyond Seres, which has been held up as an example of the potential of the microbiome sector, both from a financial and therapeutic perspective. In the good times, such as after Seres pulled off a $134 million IPO, the company has delivered a sector-wide boost to the nascent field.

http://www.mayoclinic.org/medical-professionals/clinical-updates/digestive-diseases/study-confirms-safety-efficacy-of-ser-109 [mayoclinic.org]
http://www.fiercebiotech.com/biotech/seres-shares-crash-after-microbiome-drug-flunks-phii [fiercebiotech.com]
https://en.wikipedia.org/wiki/Clostridium_difficile_colitis [wikipedia.org]


Original Submission