The primary study objective in DEP is to assess the percentage change in blood Phe level.
The secondary objectives in Period 1 are to assess the absolute change in Phe level; to assess the safety and tolerability of SYNB1934; to assess the proportion of patients with a ≥ 20% reduction in blood Phe concentration; and, to assess proportion of patients achieving blood Phe ≤ 360 μmol/L.
Exploratory objectives in DEP are to determine the responder population for RWP, assess the absolute and relative change in blood Phe concentration; and to assess the proportion of patients achieving a blood Phe ≤ 600 μmol/L.