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SYNB1618 · 2 trials · 2 indications
The primary efficacy outcome will be assessed by measuring change from baseline in plasma D5-Phe AUC over 24 hours after D5-Phe administration
Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, electrocardiograms, and any other medically indicated assessments, including subject interviews, 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 |
|---|---|---|
| SYNB1618 | EXPERIMENTAL | Dose ramp of SYNB1618 |
| SYNB1934 | EXPERIMENTAL | Dose ramp of SYNB1934 |
| SAD HV: SYNB1618 (1 x 10^10 CFU) | EXPERIMENTAL | HV subjects receive a single oral dose of SYNB1618 (1 x 10\^10 colony-forming units \[CFU\]) in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| SAD HV: SYNB1618 (5 x 10^10 CFU) | EXPERIMENTAL | HV subjects receive a single oral dose of SYNB1618 (5 x 10\^10 CFU) in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| SAD HV: SYNB1618 (1 x 10^11 CFU) | EXPERIMENTAL | HV subjects receive a single oral dose of SYNB1618 (1 x 10\^11 CFU) in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| SAD HV SB: SYNB1618 (1 x 10^11 CFU) | EXPERIMENTAL | HV subjects receive a single oral dose of SYNB1618 (1 x 10\^11 CFU) in a chilled buffered solution on Day 1 in the SAD study (Part 1). On Day 1, subjects in this cohort receive a solid breakfast (SB) that contains approximately the same amount of calories and protein as the meal supplement shake given to subjects in the other SAD cohorts. |
| SAD HV: SYNB1618 (2 x 10^11 CFU) | EXPERIMENTAL | HV subjects receive a single oral dose of SYNB1618 (2 x 10\^11 CFU) in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| SAD HV: SYNB1618 (5 x 10^11 CFU) | EXPERIMENTAL | HV subjects receive a single oral dose of SYNB1618 (5 x 10\^11 CFU) in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| SAD HV: Placebo | PLACEBO_COMPARATOR | HV subjects receive a single oral dose of placebo in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| SAD PKU: SYNB1618 (7 x 10^10 CFU) | EXPERIMENTAL | Subjects with PKU receive a single oral dose of SYNB1618 (7 x 10\^10 CFU) in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| SAD PKU: Placebo | PLACEBO_COMPARATOR | HV subjects receive a single oral dose of placebo in a chilled buffered solution on Day 1 in the SAD study (Part 1). |
| MAD HV: SYNB1618 (1 x 10^10 CFU) | EXPERIMENTAL | HV subjects receive oral SYNB1618 (1 x 10\^10 CFU) in a chilled buffered solution 3 times per day (TID) for 7 days in the MAD study (Part 2). |
| MAD HV: SYNB1618 (5 x 10^10 CFU) | EXPERIMENTAL | HV subjects receive oral SYNB1618 (5 x 10\^10 CFU) in a chilled buffered solution TID for 7 days in the MAD study (Part 2). |
| MAD HV: SYNB1618 (7 x 10^10 CFU) | EXPERIMENTAL | HV subjects receive oral SYNB1618 (7 x 10\^10 CFU) in a chilled buffered solution TID for 7 days in the MAD study (Part 2). |
| MAD HV: SYNB1618 (1 x 10^11 CFU) | EXPERIMENTAL | HV subjects receive oral SYNB1618 (1 x 10\^11 CFU) in a chilled buffered solution TID for 7 days in the MAD study (Part 2). |
| MAD HV: Placebo | PLACEBO_COMPARATOR | HV subjects receive oral placebo in a chilled buffered solution TID for 7 days in the MAD study (Part 2). |
| MAD PKU: SYNB1618 (7 x 10^10 CFU) | EXPERIMENTAL | Subjects with PKU receive oral SYNB1618 (7 x 10\^10 CFU) in a chilled buffered solution TID for 7 days in the MAD study (Part 2). |
| MAD PKU: Placebo | PLACEBO_COMPARATOR | Subjects with PKU receive oral placebo in a chilled buffered solution TID for 7 days in the MAD study (Part 2). |
| Name | Type | Description |
|---|---|---|
| SYNB1618 | DRUG | 15-day dose-ramp regimen (4 dose levels) of orally administered SYNB1618 |
| SYNB1934 | DRUG | 15-day dose-ramp regimen (4 dose levels) of orally administered SYNB1934 |
| Placebo | DRUG | Subjects receive placebo orally in a chilled buffered solution (100 mL). |
Inclusion Criteria: 1. Age ≥ 18 years. 2. Able and willing to voluntarily complete the informed consent process. 3. Diagnosis of classic PKU based on medical history as assessed by the investigator (e.g., Phe concentration of \>1200 µmol/L at any time, low dietary Phe tolerance, or genetic diagnosi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| BioMarin Pharmaceutical Inc. | BMRN | 5 | PHASE3 | Pegvaliase |
| PTC Therapeutics, Inc. | PTCT | 2 | PHASE3 | PTC923 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR444836 |
| Agios Pharmaceuticals, Inc. | AGIO | 1 | PHASE1 | AG-181 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
| Q32 Bio Inc | QTTB | 1 | - | HMI-102 |
SYNB1618 is an investigational drug being developed for the treatment of phenylketonuria, a metabolic disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in adult patients with phenylketonuria.
SYNB1618 is being developed by Synlogic, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker SYBX. The company is conducting clinical trials to evaluate the safety and efficacy of SYNB1618 in patients with phenylketonuria.
SYNB1618 is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 study and a Phase 2 study. The drug is investigational and has not received FDA approval for any indication.
SYNB1618 has been studied in two completed clinical trials. NCT03516487 was a Phase 1 study in healthy volunteers and adults with phenylketonuria, enrolling 70 participants. NCT04534842 was a Phase 2 study in adults with phenylketonuria, enrolling 20 participants. Both trials were conducted in the United States.
SYNB1618 and SYNB1934 are separate investigational drugs, but they were both evaluated in the same Phase 2 clinical trial, NCT04534842, for the treatment of phenylketonuria. The trial assessed the efficacy and safety of both drugs in adult patients with this condition.