Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)

Summary

SYNB1934-CP-003 was designed as a 3-part, adaptive study consisting of a dose-escalating, open-label period (DEP; Part 1) of up to 15 weeks, followed by a 4-week, double-blind, placebo-controlled, randomized withdrawal period (RWP; Part 2), and an open-label extension (OLE; Part 3) of up to 36 months

Timeline

Start

2023-07-05

Primary completion

2024-03-15

Completion

2024-03-15

Outcome

Outcome not reported

Stopped: “Based on a review of interim data from participants in the dose-escalation phase, it was determined that the study was unlikely to meet the primary endpoint.”

Drugs

Indications