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SEC Filings

8-K
SERES THERAPEUTICS, INC. filed this Form 8-K on 10/16/2017
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Slide 12

Intent-to-Treat statistical analyses Patients analyzed Limited to observed data All patients with post-treatment endoscopy results were included in the efficacy analysis if they remained in the trial until Day 48 Typically used in earlier stage clinical studies 53 / 58 subjects All subjects, missing data counted as failure Patients who discontinued without post-treatment endoscopy or with protocol violations were considered treatment failures in the efficacy analysis Typically used in registrational clinical studies 58 / 58 subjects Two prespecified Intent-to-Treat (ITT) statistical methods were used to analyze SER-287 Phase 1b efficacy outcomes: Initial top-line reported results Note: A patient in the placebo study arm experienced a disease flare and was treated with corticosteroids (a protocol violation) prior to the end of treatment endoscopy. Endoscopy showed improvement and the patient was assessed as having achieved clinical remission per the observed data statistical approach however in the all subjects, missing data approach they were considered a failure due to the protocol violation. SER-287 Phase 1b efficacy analyses


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