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SEC Filings

8-K
SERES THERAPEUTICS, INC. filed this Form 8-K on 06/12/2017
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Slide 13

SER-109 Phase 1b and Phase 2 (8-week) study results n=59 n=30 n=28 n=15 n=31 n=15 Phase 1b Open Label, Single-Arm (n=30; 4 sites) Phase 2 – Interim results Randomized, Placebo-Controlled (n=89; randomized 2:1; 28 sites) Primary Endpoint CDI recurrence up to 8 weeks defined by: >3 unformed stools over 1 day CDI recurrence up to 8 weeks defined by: ≥3 unformed stools/day for ≥2 days Efficacy 13% recurrence per protocol 3 of 4 patients with recurrent transient diarrhea, did not require antibiotic treatment and tested negative for C. diff. at 8 weeks SER-109: 44% (26 of 59) recurrence Placebo: 53% (16 of 30) recurrence Relative risk recurrence between arms not significant Safety Most AEs were mild to moderate and transient Most frequent AEs were gastrointestinal symptoms similar in nature to that seen in FMT trials or following CDI SER-109 is well-tolerated with an acceptable safety profile, it was associated with a small increase in gastrointestinal adverse effects, particularly diarrhea, compared to placebo (25% vs 14%) Phase 1b study results: Khanna et al. The Journal of Infectious Diseases; Phase 2 results: see July 31, 2016 press release (study results), and January 31, 2017 press release (Phase 2 study analyses)


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