Novel Synthetic Bio Drug for Hyperammonemia Granted Fast Track
Synlogic announced that the Food and Drug Administration (FDA) has granted Fast Track Designation to their investigational drug SYNB1020 for the treatment of hyperammonemia due to urea cycle disorders (UCDs).
A Phase 1 study of SYNB1020 has been initiated in healthy volunteers to test its safety and tolerability. Following successful completion of this trial, the Company plans to enroll patients with UCD and hepatic encephalopathy (HE) in two clinical trials by mid-2018.
SYNB1020 is an oral synthetic biotic medicine designed to correct dysregulated metabolic functions or synthesize substances that treat disease. The FDA designated SYNB1020 as Orphan Drug in August 2016.
Synthetic Biotic medicines utilize synthetic biology to reprogram probiotic bacteria to perform critical functions that compensate for those missing or damaged due to a particular disease. The drugs are developed to remove toxic metabolites associated with specific metabolic diseases.
For more information visit SynlogicTx.com.