Trial Profile
A Phase 3, Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 24 Sep 2025
Price :
$35
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At a glance
- Drugs Labafenogene marselecobac (Primary) ; Escherichia-coli; Esomeprazole; Ondansetron
- Indications Phenylketonuria
- Focus Proof of concept; Registrational; Therapeutic Use
- Acronyms Synpheny-3
- Sponsors Synlogic
Most Recent Events
- 08 Feb 2024 According to a Synlogic media release, the company to discontinue this trial based on results of an internal review in advance of an upcoming independent Data Monitoring Committee (DMC) assessment, which indicated the trial was unlikely to meet its primary endpoint. The decision was not based on concerns regarding safety or tolerability. Synlogic will now work with the Synpheny-3 clinical trial sites involved to implement the discontinuation.
- 08 Feb 2024 Status changed from recruiting to discontinued, according to a Synlogic media release.
- 11 Jul 2023 According to a Synlogic media release, the company chose Science 37 to provide virtual clinical trial technology and services for this trial. The Science 37 Metasite will expand access to the trial for patients who may be unable or prefer not to travel to research sites for study visits and also provide its unified platform to the study's physical research sites, ensuring end-to-end data quality and consistency, no matter where or how data is captured.