Exhibit 99.1 |
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Synlogic DESIGNED FOR LIFE SYNB1618Phase1/2a Clinical Trial Topline Data from PKU Patient CohortsJuly 15th, 2019
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SYNB1618 Potential to Address Unmet Need Across Patient Groups 360 mmol /L Uncontrolled Adults Partially Controlled Adults(Adults on Kuvanand/or low-Phe Diet) Pediatric Patients (controlled / partially controlled) (Pediatric patients on Kuvan and / or low-Phe diet Phe Natural protein Phe Phe Initial Focus
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SYNB1618 Phase 1/2a Study Design Single Ascending Dose (SAD)6 cohorts, N = 24 Multiple Ascending Dose (MAD)- TID x 7 days4 cohorts, N = 32 Dose ID Single Dose (SD)N = 4 Multiple Dose (MD)TID x 7 daysN =10 Dose Confirm MTD Part 1: Healthy Volunteers Part 2: PKU Patients PKU Clinical Trial DesignRandomized, double-blind placebo-controlled study at multiple sites in the US Primary outcome: establish safety/tolerability following single and multiple doses in HV and PKU patients Secondary outcome: SYNB1618 kinetics in fecesExploratory: change from baseline in plasma and urinary biomarkers of Phe metabolism Presented in September 2018 New Data
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SYNB1618 Activity Biomarkers Indicate Significant Phe Consumption Similar activity in HVs and PKU Patients
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Modeling: Potential For Phe Reduction in PKU Patients % Blood Phe lowering 7x1010 1x1011 3x1011 5x1011 125100755025 TPP >30% SYNB1618 Dose (CFU) 8-18% 11-26% 34-79% 57-131% Ranges representLow: PAL mechanism only (conservative) High: PAL + LAAD activity (estimates maximum with both pathways)
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Upcoming Milestones and Path Forward Established new solid formulation and manufacturing process Completed EPO1 interactions with FDA to align on program plans (clinical, manufacturing, toxicology) Completed Phase 1/2a study (healthy volunteers and PKU patients)Initiate bridging study with solid formulation in Q3 2019Phase 2 study in PKU patients to assess Phe lowering to start in 1H 2020
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