secwatch.observer — SEC 8-K summary
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Issuer:     SYNLOGIC, INC. (SYBX)
CIK:        0001527599
Form:       8-K
Filed at:   2022-10-18T23:59:59+00:00
Accession:  0001193125-22-264177
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Synlogic reports positive Phase 2 PKU data; SYNB1934 advances to Phase 3 in H1 2023
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1527599/000119312522264177/0001193125-22-264177-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1527599/000119312522264177/d387982d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-264177

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer