Enanta Pharmaceuticals launched the first part of a phase 1a/b clinical study of EDP-514 for the treatment of hepatitis B, according to a press release.
EDP-514 is a novel class 2 HBV capsid assembly modulator that has demonstrated a potent inhibiting of HBV replication and prevention of de novo formation of new covalently closed circular DNA in human hepatocytes.
The randomized control trial will evaluate both single- and multiple-ascending doses of EDP-514 for antiviral activity along with safety in patients whose HBV has been suppressed with nucleos(t)ide therapy. The study will include approximately 98 patients.
“Our diverse pipeline continues to advance, with clinical trials ongoing in all of our wholly-owned programs in [nonalcoholic steatohepatitis, primary biliary cirrhosis, respiratory syncytial virus] and now HBV,” Jay R. Luly, PhD, president and CEO of Enanta, said in the release. “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. Receipt of Fast Track designation from the FDA emphasizes the large unmet need of patients with chronic HBV infection.”