Synlogic, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to labafenogene marselecobac (previously known as SYNB1934) for the treatment of phenylketonuria (PKU). Labafenogene marseleCobac has also received Rare Disease Designation (RPDD) and Orphan Drug Designation (ODD) by the FDA and orphan designation from the European Medicines Agency (EMA). The FDA's Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

To qualify, available clinical and non-clinical data need to demonstrate meaningful therapeutic potential. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a registrational filing for approval on a rolling basis, and eligibility for priority review, if relevant criteria are met. Labafenogene marselcobac (previouslyknown as SYNB1934) is an orally administered, non-systemically absorbed, potential treatment for phenylalanine (Phe), an amino acid found in all protein-containing foods.

Results to date indicate the potential for labafenogene marseLEcobac as the first therapeutic for PKU approved as both a monotherapy and adjunctive medical treatment, and following successful Phase 2 results, it has advanced to Synpheny-3, a global, pivotal Phase 3 study. Labafenogene mar Selecobac has received Orphan Drug Designation (odD), Fast Track designation and Rare Pediatric Disease Designation (RPD D) from the FDA in addition to orphan designation from the European Medicine Agency (EMA).