Enanta Pharmaceuticals has launched a Phase Ib clinical trial of EDP-514, a hepatitis B virus (HBV) core inhibitor, in viremic HBV patients.
The company also restarted its ongoing Phase Ib trial in HBV patients who were treated with a nucleos(t)ide reverse transcriptase inhibitor (NUC-suppressed patients). This trial was temporarily paused due to the Covid-19 pandemic.
Core inhibitors are known to act by targeting various steps in the HBV lifecycle.
In preclinical studies, EDP-514 was able to inhibit HBV replication and prevent the denovo formation of new cccDNA in primary human hepatocytes when administered in the early stages of the infection.
Enanta Pharmaceuticals president and CEO Jay Luly said: “EDP-514, a novel core inhibitor of HBV replication, leverages our strength in compound optimisation and targeted rational design, enabling potent anti-HBV activity at multiple steps in the HBV lifecycle.
“We are excited to further investigate EDP-514 in viremic HBV patients, and look forward to reporting preliminary safety and virologic data in the first half of 2021, while also completing our study in NUC-suppressed patients with top-line data expected in the second quarter of 2021.”
The randomised, double-blind, placebo-controlled Phase Ib study in viremic chronic HBV patients will assess the safety, tolerability, pharmacokinetics, and antiviral activity of three ascending doses of oral EDP-514 over 28 days in 24 subjects.
Meanwhile, the Phase Ib study in NUC-suppressed patients is the second part of a Phase Ia/Ib trial.
This Phase Ib part will also investigate the safety, tolerability, pharmacokinetics, and antiviral activity of three ascending doses of oral formulation of the drug candidate in 24 participants.
The first part of the Phase Ia/Ib trial tested EDP-514 in healthy subjects, who were given single or multiple doses for up to 14 days. EDP-514 was observed to be well tolerated, with a favourable safety profile.
During the study, treatment-emergent adverse events were reported to be infrequent and mild in intensity.