Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Technical Presentation (October 2017)
22 slides from Seres Therapeutics's technical presentation, Oct 16, 2017
Slide 1: SER-287 Phase 1b Ulcerative Colitis study results review
SER-287 Phase 1b Ulcerative Colitis study results review October 2017 Exhibit 99.1
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, including statements on the timing of additional data for the SER-287 Phase 1b study, the efficacy of SER-287, expected interacti
Slide 3: Robust microbiome therapeutics pipeline
PRECLINICAL PHASE 1b PHASE 2 Synthetically fermented Infectious Inflammatory SER-301 Inflammatory Bowel Disease (IBD) SER-262 Primary C. difficile Top line SER-287 Phase 1b data disclosed in October 2, 2017 press release; Collaboration with Nestlé Health Science regarding C. difficile and IBD progra
Slide 4: 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, reducing
Slide 5: Ulcerative Colitis Overview: Treatment Approach and Unmet Need
Chronic relapsing inflammatory disease affecting colon and rectum Symptoms reflect differences in severity of disease and include: Abdominal pain, bowel urgency, diarrhea, and blood in the stool Ulcerative Colitis Overview Goal of treatment: Induce and maintain long-term remission Mild to moderate:
Slide 6: Multiple FMT studies provide proof-of-concept in Ulcerative Colitis
Multiple FMT studies provide proof-of-concept of clinical benefit in patients with Ulcerative Colitis Subject A, Baseline Subject A, 8-wk post FMT Selected references: Paramsothy et al. Lancet, 2017; Moayyedi et al. Gastroenterology, 2015; Review article: Costello et al. Alimentary Pharmacology & Th
Slide 7: Ulcerative Colitis study design
SER-287 Phase 1b Ulcerative Colitis study 58 mild-moderate UC patients failing standard of care* * Study designed to enroll 55 patients, with 15 in SER-287 treatment arms and 10 in the placebo / placebo arm Arm C: Placebo pre-treatment / SER-287 once weekly dosing for 8 weeks (n=15) Arm A: Placebo p
Slide 8: 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 biomarkers
Slide 9: Definitions of clinical efficacy endpoints
Definitions of clinical efficacy endpoints Endpoint Protocol Definition New FDA Definition (2016)* Clinical Remission Total Modified Mayo Score <=2 and an endoscopic subscore of 0 or 1 Stool Frequency subscore =0, Rectal Bleeding subscore=0 and Endoscopic subscore = 0 or 1(modified) on Mayo Score En
Slide 10: Pooled placebo clinical response and remission rates
Pooled estimates of Placebo Clinical Response rates: 33% (95% CI 29-37%) Pooled estimates of Placebo Clinical Remission rates: 10% (95% CI 7-13%) Jairath V. et al., Journal of Crohn's and Colitis, 2016 UC studies have high placebo Clinical Response rates - Not an FDA recommended endpoint
Slide 11: Clinical Remission is now recommended by FDA as primary endpoint
Clinical Remission is now recommended by FDA as the primary endpoint for UC registrational studies “We currently recommend a primary endpoint of clinical remission (responder definition based on Stool Frequency, Rectal Bleeding, and Endoscopy scores).” Clinical Remission is based on objective endosc
Slide 12: Intent-to-Treat statistical analyses
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
Slide 13: Efficacy Analysis: Limited to observed data
Efficacy Analysis: Limited to observed data Endpoint Intent-to-Treat Population: Limited to Observed Data Placebo / Placebo (N = 10) (%) Vancomycin / SER-287 daily (N = 15) (%) Placebo / SER-287 weekly (N = 14) (%) Vancomycin / SER-287 weekly (N = 14) (%) Clinical Remission: 1/10 (10%) 6/15 (40%) 2/
Slide 14: Efficacy Analysis: All subjects, missing data counted as failure
Efficacy Analysis: All subjects, missing data counted as failure Endpoint Intent-to-Treat Population: All Subjects, Missing Data Counted as Failure Placebo / Placebo (N = 11) (%) Vancomycin / SER-287 daily (N = 15) (%) Placebo / SER-287 weekly (N = 15) (%) Vancomycin / SER-287 weekly (N = 17) (%) Cl
Slide 15: SER-287 safety and tolerability profile very favorable
SER-287 safety and tolerability profile very favorable System Organ Class Safety Population (Placebo / placebo) (N = 11) n (%) (Vancomycin / SER-287 daily) (N = 15) n (%) (Placebo / SER-287 weekly) (N = 15) n (%) (Vancomycin / SER-287 weekly) (N = 17) n (%) SER-287 (N = 47) n (%) Gastrointestinal di
Slide 16: Microbiome results expected in coming months
Microbiome results expected in coming months Microbiome analyses to include: Increase in the total bacterial diversity Prevalence of SER-287 spore-former species Identification of bacteria that correlate with efficacy Pending microbiome results to inform: Future SER-287 clinical development plans Ad
Slide 17: Summary: Promising signals of efficacy, favorable safety profile
SER-287 Phase 1b summary: Promising signals of efficacy, with a favorable safety profile SER-287 resulted in a dose-dependent, favorable impact on both Clinical Remission and Endoscopic Improvement Clinical Remission recommended by FDA as the primary endpoint for UC registrational studies Effects on
Slide 18: Advancing SER-287 clinical development
Advancing SER-287 clinical development Company expects to meet with the FDA to determine the most accelerated path to advance SER-287 development in Ulcerative Colitis, both as an induction and a maintenance therapy Company also intends to assess future development in Crohn’s disease and pediatric f
Slide 19: Appendix
——— Ve Appendix
Slide 20: Phase 1b study patient demographics
Phase 1b study patient demographics Characteristic Statistic (Placebo/ Placebo) (N = 11) (Vancomycin / SER-287 daily) (N = 15) (Placebo/SER-287 weekly) (N = 15) (Vancomycin / SER-287 weekly) (N = 17) Ser-287 (N = 47) Overall (N = 58) Age (years) n 11 15 15 17 47 58 Mean (SD) 45.8 (15.20) 47.8 (18.59
Slide 21: Overall safety: most common adverse events by treatment group
SER-287 Phase 1b overall safety: most common (>5%) adverse events by treatment group Safety Population Preferred Term Placebo / Placebo (N = 11) n (%) Vancomycin / SER-287 daily (N = 15) n (%) Placebo / SER-287 weekly (N = 15) n (%) Vancomycin / SER-287 weekly (N = 17) n (%) SER-287 (N = 47) n (%) T
Slide 22: Mayo Score components
Mayo Score components Mayo Score Total Modified Mayo Score Stool Frequency 0 = Normal 1 = 1 – 2 stools/day more than normal 2 = 3 – 4 stools/day more than normal 3 = >4 stools/day more than normal Same Rectal Bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood wi
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