Synlogic has dosed the first patient in its Phase Ib/IIa clinical trial of SYNB1020 to treat patients with cirrhosis.
The randomised, double-blind, placebo-controlled trial aims 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.
The first part of the trial includes an initial sentinel open-label cohort of subjects with cirrhosis and a Model for End-Stage Liver Disease (MELD) score < 12.
In this part, the patients will receive orally administered SYNB1020 for six days.
The patients will be admitted to an inpatient facility for a run-in diet, baseline assessments, safety monitoring, and collection of blood, urine, and fecal samples for assessing safety, tolerability, pharmacokinetics and pharmacodynamics of treatment.
Following the establishment of the safety and tolerability of SYNB1020 in these subjects, Synlogic will start enrolling patients for the trial’s second part.
The randomised, double-blinded, placebo-controlled part two study will be conducted in patients with cirrhosis and hyperammonemia.
Eligible patients will be admitted to an inpatient facility for a run-in diet and 24-hour ammonia profile, while patients with an elevated ammonia level will proceed with randomisation and receive either placebo or orally administered SYNB1020 for six days.
Top-line data from the trial is expected by the end of this year.
Synlogic chief medical officer Aoife Brennan said: “Our recently reported Phase I 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.
“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.”
SYNB1020 is one of two lead programmes by Synlogic. It is a Synthetic Biotic medicine being developed for the treatment of hyperammonemia, associated with cirrhosis and urea cycle disorders (UCDs) that can have severe and life-threatening consequences on patients.