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Adjusted LOA
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SYNB1934 · 1 trial · 1 indication
Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and any other medically indicated assessments from the time informed consent is signed through the end of the safety follow-up period. AEs are considered to be treatment emergent (TEAE) if they occur or worsen in severity after the first dose of study treatment. TEAEs are considered treatment-related if relationship to study drug is possibly related, probably related, or definitely related.
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1 MAD HV: SYNB1934 (3 x 10^11 live cells) | EXPERIMENTAL | HV subjects receive SYNB1934 (3 x 10\^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 2 Crossover HV: SYNB1934 (6 x 10^11 live cells) | EXPERIMENTAL | HV subjects receive SYNB1934 (6 x 10\^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 7-day washout period HV subjects receive SYNB1618 (6 x 10\^11 live cells), at least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 3 MAD HV: SYNB1934 (1 x 10^12 live cells) | EXPERIMENTAL | HV subjects receive SYNB1934 (1 x 10\^12 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 4 MAD HV: SYNB1934 (optional) | EXPERIMENTAL | HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 5 MAD HV: SYNB1934 (optional) | EXPERIMENTAL | HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 2 Crossover with PPI vs No PII | EXPERIMENTAL | HV subjects receive SYNB1934 (at or below the MTD from Part 1) with PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 14-day washout period HV subjects receive SYNB1934 (at or below the MTD from Part 1) without PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Name | Type | Description |
|---|---|---|
| SYNB1934 | DRUG | SYNB1934 is formulated as a nonsterile solution intended for oral administration |
| SYNB1618 | DRUG | SYNB1618 is formulated as a nonsterile solution intended for oral administration |
Inclusion Criteria: 1. Age ≥ 18 to ≤ 64 years. 2. Able and willing to voluntarily complete the informed consent process. 3. Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, inpatient monitoring, follow-up visits, and compli...
Top 5 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| BioMarin Pharmaceutical Inc. | BMRN | 5 | PHASE3 | Pegvaliase, BMN 307 |
| PTC Therapeutics, Inc. | PTCT | 1 | PHASE3 | Sepiapterin |
| Maze Therapeutics, Inc. | MAZE | 1 | PHASE2 | MZE782 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR444836 |
| Agios Pharmaceuticals, Inc. | AGIO | 1 | PHASE1 | AG-181 |
SYNB1934 is an investigational oral small molecule developed by Synlogic, Inc. for phenylketonuria, a rare inherited disorder of amino acid metabolism. It has been studied in a completed Phase 1 trial in healthy adult volunteers. It is not an approved therapy and remains in clinical development.
SYNB1934 is being developed for phenylketonuria, a rare metabolic condition. The only reported clinical study of SYNB1934 enrolled healthy adult volunteers rather than patients with phenylketonuria, so its use in the disease population remains under investigation. It has received a Rare Pediatric Disease designation from the FDA.
SYNB1934 is developed by Synlogic, Inc., a biotechnology company whose common stock trades on the Nasdaq under the ticker SYBX. Synlogic is the sponsor of the clinical program evaluating SYNB1934 for phenylketonuria.
SYNB1934 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently listed as active. Because it is investigational, SYNB1934 has not been approved by the FDA for any indication, though it holds a Rare Pediatric Disease designation.
SYNB1934 has been evaluated in one completed Phase 1 trial, NCT04984525, titled Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers. That randomized, double-blind, controlled study enrolled 106 healthy adults aged 18 years and older in the United States.