Slide 1: SER-287 Phase 1b topline study results in patients with mild-to-moderate Ulcerative Colitis
SER-287 Phase 1b topline study results in patients with mild-to-moderate Ulcerative Colitis October 2, 2017 L e ad i n g t h e M i c ro b i o me R e vo l u t i o n
Slide 2: Forward Looking Statements
Forward Looking Statements Some of the statements in this presentation constitute “forward looking statements” under the Private Securities Litigation Reform Act of 1995. Such statements are subject to factors, risks and uncertainties (such as those detailed in the Company’s periodic filings with th
Slide 3: Seres Overview
Seres Overview Phase 3 stage company developing microbiome-based Opportunity therapeutics, a highly promising new area of medicine Leader in microbiome drug development Platform with differentiated capabilities Broad pipeline in infectious, inflammatory and Pipeline immune, metabolic and liver disea
Slide 4: Robust Microbiome Therapeutics Pipeline
Robust Microbiome Therapeutics Pipeline PRECLINICAL PHASE 1 PHASE 2 PHASE 3 SER-109 Recurrent C. difficile SER-262 Primary C. difficile Positive top-line SER-287 Ulcerative colitis Phase 1b results SER-301 Inflammatory Bowel Disease (IBD) Prevention of infection and GVHD following SER-155 hematopoie
Slide 5: SER-287 Overview
SER-287 Overview • Biologically sourced consortium of bacterial spores • Orally administered • Strong intellectual property protection supported by multiple patent claims covering Ulcerative Colitis, as well as regulatory data protection • Hypothesized to act by modulating the dysbiotic microbiome,
Slide 6: SER-287 Opportunity in Ulcerative Colitis
SER-287 Opportunity in Ulcerative Colitis Significant need for improved Ulcerative Colitis therapies • Large population: ~700K ulcerative colitis (US figures) • Many ulcerative colitis patients do not respond to current therapies, both during induction and maintenance, and there is need for new trea
Slide 7: SER-287 Phase 1b Ulcerative Colitis Study Design
SER-287 Phase 1b Ulcerative Colitis Study Design Arm A: Placebo pre-treatment / Intent to treat, observed case Placebo once daily for 8 weeks population for efficacy analysis = (n=11) 10 subjects Arm B: Vancomycin pre- Intent to treat, observed case 58 mild- treatment / SER-287 once daily population
Slide 8: SER-287 Phase 1b Study Endpoints
SER-287 Phase 1b Study Endpoints Primary Objectives • Safety and tolerability • Change in composition of intestinal microbiome at 8 weeks * Secondary Objectives • Clinical remission, endoscopic improvement and response through measure of the total modified Mayo Score • Change in serum and fecal biom
Slide 9: Phase 1b Study Patient Demographics
Phase 1b Study Patient Demographics (Placebo/ (Vancomycin / (Placebo/SER- (Vancomycin / Ser-287 Overall Statistic Placebo) SER-287 daily) 287 weekly) SER-287 weekly) (N = 47) (N = 58) Characteristic (N = 11) (N = 15) (N = 15) (N = 17) Age (years) n 11 15 15 17 47 58 Mean (SD) 45.8 (15.20) 47.8 (18.5
Slide 10: SER-287 Phase 1b Study Clinical Efficacy Endpoints
SER-287 Phase 1b Study Clinical Efficacy Endpoints Endpoint Intent to Treat Population, Observed Case: Treatment Group Placebo / Vancomycin / Placebo / SER-287 Vancomycin / SER- Placebo SER-287 daily weekly 287 weekly (N = 10) (%) (N = 15) (%) (N = 14) (%) (N = 14) (%) Clinical Remission 1/10 (10.0)
Slide 11: Treatment-Emergent Adverse Events Incidence by Treatment and System Organ Class
Treatment-Emergent Adverse Events Incidence by Treatment and System Organ Class System Organ Class Safety Population (Placebo / (Vancomycin / (Placebo / SER- (Vancomycin / SER-287 placebo) SER-287 daily) 287 weekly) SER-287 weekly) (N = 47) (N = 11) (N = 15) (N = 15) (N = 17) n (%) E n (%) E n (%) E
Slide 12: Overall Safety: Most Common (>5%) Adverse Events by Treatment Group
SER-287 Phase 1b Overall Safety: Most Common (>5%) Adverse Events by Treatment Group Safety Population Placebo / Vancomycin / Placebo / Vancomycin / SER-287 SER-287 SER-287 Placebo SER-287 daily Preferred Term weekly weekly (N = 47) (N = 11) (N = 15) (N = 15) (N = 17) n (%) n (%) n (%) n (%) n (%) T
Slide 13: Advancing SER-287 Clinical Development
Advancing SER-287 Clinical Development • Phase 1b top line results summary: o SER-287 microbiome treatment resulted in a benefit in clinical remission rates, as well as an improvement in endoscopic scores o No clinically significant safety or tolerability findings were observed o Microbiome results