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SYNB1618

Development stage: Phase 2
Lead developer: Synlogic
Modality: Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration: Oral

Overview

SYNB1618 is an orally administered, investigational live biotherapeutic product for the treatment of Phenylketonuria (PKU). [1] Developed by Synlogic, it is a genetically engineered strain of the probiotic Escherichia coli Nissle 1917. [2, 4] The bacterium is designed to consume the amino acid phenylalanine (Phe) in the gastrointestinal (GI) tract. [3] It expresses two enzymes to achieve this: phenylalanine ammonia lyase (PAL), which converts Phe to trans-cinnamic acid (TCA), and L-amino acid deaminase (LAAD), which converts Phe to phenylpyruvic acid. [4] By breaking down Phe in the gut, SYNB1618 aims to lower its absorption into the bloodstream, thereby reducing the high Phe levels that are toxic to the brain in individuals with PKU. [3, 4] The U.S. FDA has granted SYNB1618 both Orphan Drug Designation and Fast Track designation. [3] An improved version, SYNB1934 (labafenogene marselecobac), was later developed and advanced into late-stage trials before being discontinued. [11, 10]

Targets

Phe (L-phenylalanine)

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