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SYNB8802v1 · 1 trial · 1 indication
Vital Signs Resting vital signs will be collected as specified in the protocol. Subjects are required to remain in the sitting position for at least 5 minutes prior to obtaining vital signs. A symptom-directed physical examination will be performed by trained medical personnel as specified in the protocol.
The clinical laboratory tests listed in the protocol will be performed at the time points specified in the protocol's schedule of assessments.
Adverse events will be assessed continuously by direct observation and subject event recording and interviews. The severity of AEs will be evaluated using the NCI CTCAE, version 5.0 criteria.
| Arm | Type | Description |
|---|---|---|
| SYNB8802v1 | EXPERIMENTAL | Dose ramp to 1 × 1011 QD and then dose ramp to 3 × 1011 TID SYNB8802v1 live cells |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered during the dose ramp such that all subjects receive IMP dosing TID |
| Name | Type | Description |
|---|---|---|
| SYNB8802v1 | DRUG | SYNB8802v1 is an orally administered, non-systemically absorbed live biotherapeutic developed for the treatment of EH. The strain converts oxalate to formate and CO2, two naturally occurring GI metabolites. SYNB8802 was developed by engineering a pathway for oxalate degradation in a probiotic strain of Escherichia coli Nissle 1917 (EcN). It is intended to act within the GI tract to reduce the oxalate levels in patients with EH by converting oxalate to formate and CO2, two naturally occurring GI metabolites. |
| Placebo | OTHER | placebo powder will be aliquoted into high density polyethylene (HDPE) bottles and diluted in the same formulation buffer as SYNB8802v1 lyophilized powder. The placebo consists of corn starch and dyes to color match the placebo to the SYNB8802v1 powder for oral suspension |
Inclusion Criteria: * Age ≥ 18 to ≤ 74 years. * Able and willing to voluntarily complete the informed consent process. * Available for, and agree to, all study procedures, including fixed diet, feces, urine, and blood * collection, follow-up visits, and compliance with all study procedures. * Histo...
SYNB8802v1 is an investigational drug being developed for enteric hyperoxaluria, a condition characterized by excess oxalate absorption in the gut. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with a history of gastric bypass surgery or short-bowel syndrome.
SYNB8802v1 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, tolerability, and pharmacodynamics of the drug in patients with enteric hyperoxaluria.
SYNB8802v1 is in Phase 1 clinical development. A completed early Phase 1 trial (NCT05377112) evaluated the drug in 11 subjects with a history of gastric bypass surgery or short-bowel syndrome. The drug remains investigational and is not yet approved for any use.
SYNB8802v1 has one completed clinical trial, NCT05377112, titled "Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome." This early Phase 1 study enrolled 11 participants in the United States and was randomized, double-blind, and placebo-controlled.
No, SYNB8802v1 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for enteric hyperoxaluria. The completed early Phase 1 trial assessed safety, tolerability, and pharmacodynamics, but the drug has not yet received regulatory approval for any indication.