The FDA granted fast track designation to Synlogic’s (NASDAQ:SYBX) labafenogene marselecobac (previously known as SYNB1934) for the treatment of phenylketonuria (PKU).
Labafenogene marselecobac also has received rare disease designation and orphan drug designation by the FDA and orphan designation from the European Medicines Agency.
“This milestone re-enforces our own urgency as we execute our pivotal study, Synpheny-3,” Aoife Brennan, president and CEO of Synlogic, said in a statement.
Labafenogene marselecobac is an orally administered, non-systemically absorbed, potential treatment for PKU, a rare metabolic disease caused by inherited mutations that impair the breakdown of phenylalanine (Phe), an amino acid found in all protein-containing foods. The goal of PKU management is to reduce plasma Phe below neurotoxic levels, reducing risk of neurocognitive complications.
