Drug intelligence / Profile preview

labafenogene marselecobac

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
01

Overview

Labafenogene marselecobac (SYNB1934) is an orally administered, non-systemically absorbed live biotherapeutic product (LBP) developed by Synlogic for the treatment of phenylketonuria (PKU). It consists of a precision-engineered probiotic bacterial strain (*Escherichia coli* Nissle 1917) designed to consume and metabolize phenylalanine (Phe) within the gastrointestinal tract. By degrading Phe before it can be absorbed into the systemic circulation, the therapy aims to reduce blood Phe levels, which are toxic to the brain in patients with PKU. The drug was granted Orphan Drug and Rare Pediatric Disease designations by the FDA. However, in February 2024, Synlogic announced the termination of the Phase 3 Synpheny-3 study after an internal analysis indicated the trial was unlikely to meet its primary endpoint, leading the company to cease operations.

Other names
lisocabtagene maraleucel-Synlogic-phenylketonuria

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