SYNB-1618 is under clinical development by Synlogic and currently in Phase II for Phenylketonuria (PKU). According to GlobalData, Phase II drugs for Phenylketonuria (PKU) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how SYNB-1618’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

SYNB-1618 overview

SYNB-1618 is under development for the treatment of phenylketonuria (PKU). SYNB1618 is derived from a safe strain of bacteria called Escherichia coli Nissle. The therapeutic candidate is administered through oral route as a lyophilized formulation. It is a genetically modified organism (GMO) designed from natural probiotic bacteria that are engineered using Synlogic’s proprietary synthetic biology and microbiome platform to treat disease.

Synlogic overview

Synlogic, formerly TMC Therapeutics, is a clinical stage drug development company that develops novel class of living medicines for the treatment of rare and genetic metabolic diseases. The company’s pipeline includes SYNB1618 to treat the Phenylketonuria. It also produces drugs based on its proprietary synthetic biology and microbiome platform for the treatment of diseases, including liver disease, inflammatory and immune disorders, and cancer. The company’s synthetic biotics are designed to make therapeutic effects throughout the body from an initial stage in the microbiome. The company works in partnership with pharmaceutical and biotechnology companies for novel drug development in major disease areas. Synlogic is headquartered in Cambridge, Massachusetts, the US.

For a complete picture of SYNB-1618’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.