other material
confidence high
sentiment positive
materiality 0.80
Synlogic reports positive Phase 2 PKU data; SYNB1934 advances to Phase 3 in H1 2023
SYNLOGIC, INC.
- Phase 2 Synpheny-1 study met primary endpoint: 60% response rate with 42% mean Phe reduction among responders.
- SYNB1934 showed -34% mean change from baseline in fasting plasma Phe; SYNB1618 showed -20%.
- All adverse events mild/moderate, primarily GI; no serious adverse events; 3 discontinuations due to GI AEs.
- Company confirms SYNB1934 as Phase 3 candidate; pivotal study expected to begin H1 2023.
- Data from 20 adult PKU patients; results consistent with adjunctive use with sapropterin.