Synlogic is developing Synthetic BioticTM medicines, a novel class of living medicines that are based on engineered probiotic bacteria to treat serious illness. We are dedicated to delivering safe and effective therapies as quickly as possible.

Clinical Trials

One of the most important steps in this process is the clinical trial where people volunteer to receive an experimental therapy and be observed for its effects. We are conducting clinical trials to evaluate the safety and tolerability of Synthetic Biotic medicines designed to treat phenylketonuria and hyperammonemia. To learn more about our Synthetic Biotic approach and our clinical trials, please see below.

Our Approach

Phenylketonuria (PKU)

Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Patients with PKU.

Synlogic has modified a probiotic strain of E. coli, E. coli Nissle, to generate a Synthetic Biotic medicine called SYNB1618. SYNB1618 is designed to consume Phenylalanine (Phe) and reduce plasma Phe levels following oral administration. We are currently conducting clinical trials in healthy volunteers and PKU patients to demonstrate safety and to test whether this could be a useful therapeutic option for PKU patients in helping them manage their blood Phe levels.

For more information on our clinical trial please visit ClinicalTrials.gov

About PKU

In the U.S. Phenylketonuria (PKU) is believed to affect 16,500 people. PKU is the result of a defect in the gene encoding phenylalanine hydroxylase (PAH), a liver enzyme that metabolizes Phe. Phe is an essential amino acid that enters the body as a component of dietary protein and can be toxic if it accumulates in the blood and brain. Life-long Phe control is challenging due to the highly restrictive nature of the diet patients must follow. People with PKU experience worsening neurological function depending on the severity of their genetic mutation and their treatment compliance.

Hyperammonemia

Safety, Tolerability and Pharmacodynamics of SYNB1020.

Synlogic has modified a probiotic strain of E. coli, E. coli Nissle, to generate a Synthetic Biotic medicine called SYNB1020. SYNB1020 is designed to consume ammonia and reduce plasma ammonia levels following oral administration. We are currently conducting clinical trials in patients with elevated plasma ammonia due to cirrhosis to demonstrate safety and to test whether this could be a useful therapeutic for patients in helping them manage their blood ammonia levels.

For more information on our clinical trial please visit ClinicalTrials.gov

About Hyperammonemia

Hyperammonemia is a metabolic condition characterized by an excess of ammonia in the blood. In healthy individuals, ammonia is primarily produced in the intestine as a byproduct of protein metabolism. Ammonia is then converted to urea in the liver and is excreted in urine. However, if the liver’s ability to convert ammonia to urea is compromised, either due to a genetic defect such as urea cycle disorders (UCDs) or acquired liver disease that leads to cirrhosis, ammonia accumulates in the blood. Elevated blood ammonia levels are toxic to the brain and can have severe consequences, including neurologic crises requiring hospitalization, irreversible cognitive damage and death.