Biotechnology firm Enanta Pharmaceuticals has commenced the first part of a Phase Ia/b clinical trial to assess its core inhibitor candidate EDP-514 for the treatment of hepatitis B virus (HBV) infection.
Core inhibitors are a new class of replication inhibitors that are shown to act at various steps in the lifecycle of HBV virus, which causes a potentially life-threatening liver infection.
The randomised, double-blind, placebo-controlled Phase Ia/b trial will assess the safety, tolerability and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of the therapeutic.
The first part of the study will enrol healthy subjects, while the second part will involve nucleos(t)ide-reverse-transcriptase (NUC)-suppressed patients having chronic HBV infection.
After completion of the SAD and MAD portion in healthy subjects, EDP-514’s safety, PK and antiviral activity will be studied in NUC-suppressed patients with chronic HBV infection.
Enanta Pharmaceuticals president and CEO Jay Luly said: “Our diverse pipeline continues to advance, with clinical trials ongoing in all of our wholly-owned programmes in NASH, PBC, RSV, and now HBV.
“EDP-514 is a promising core inhibitor that we look forward to developing as a potential cure for the critical unmet need in HBV, either as a single agent or in combination with other therapeutics.”
In preclinical studies, EDP-514 showed its ability as a potent inhibitor of HBV replication. It also displayed its ability to prevent the denovo formation of new cccDNA in primary human hepatocytes when administered early during HBV infection.
The Phase Ia/b trial is expected to completed in December.