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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.
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