Synlogic Doses First Patient in Phase 1b/2a Trial of SYNB1020 for Treatment of Hyperammonemia in Patients with Cirrhosis

Synlogic announced that the first patient was dosed in its Phase 1b/2a clinical trial of SYNB1020. SYNB1020 is a Synthetic Biotic medicine being developed for the treatment of hyperammonemia, associated with cirrhosis and urea cycle disorders (UCDs), which can result in severe and life-threatening consequences for patients. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of SYNB1020, as well as its ability to lower blood-ammonia levels in patients with cirrhosis and elevated blood ammonia.

“Our recently reported Phase 1 trial of SYNB1020 demonstrated that this Synthetic Biotic medicine was well tolerated and provided a dose-dependent proof of mechanism, functioning as designed in healthy volunteers. We look forward to evaluating the safety, tolerability and therapeutic potential of SYNB1020 in patients with liver disease who have developed cirrhosis,” said Aoife Brennan, M.B., B.Ch., Synlogic’s chief medical officer. “There is unmet medical need for additional treatment options for patients with chronic liver disease and we are excited by the potential of SYNB1020 in this indication.”

Synthetic Biotic therapies are designed to function in the gastrointestinal tract to convert metabolites that can build up to toxic levels in the blood into harmless metabolites that can be excreted from the body. Elevated blood ammonia levels are toxic to the brain and can have severe consequences, including neurologic crises requiring hospitalization and resulting in irreversible cognitive damage and death. SYNB1020 is designed to consume ammonia and convert it to arginine, an amino acid.