Epigenic Therapeutics, a leading biotechnology company dedicated to developing next-generation gene modulation therapy, announced that it has received approval of clinical trial application (CTA) from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and The Health and Disability Ethics Committees (HDEC) to initiate a clinical trial for EPI-003, which is an investigational, liver-targeting antiviral therapy for chronic hepatitis B (CHB) virus infection. EPI-003 is set to become the world's first epigenetic therapy to reach clinical trials for this widespread infectious disease.

This first-in-human study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EPI-003 in Nucleos(t)ide Analogue-Treated, Chronic Hepatitis B Patients. The clinical trial is planned for sites in New Zealand, Australia, and Hong Kong.

EPI-003 is a breakthrough antiviral drug administered through intravenous infusion targeting the liver through epigenetic modification for the treatment of chronic hepatitis B virus (HBV) infection. CHB is a liver infection that can progress from asymptomatic stages to cirrhosis, liver failure, and hepatocellular carcinoma (HCC). The primary challenge in curing chronic hepatitis B is the persistent presence of HBV covalently closed circular DNA (cccDNA) and integrated genomic DNA within the liver, which results in sustained viral surface antigenemia. Current antiviral treatments for hepatitis B can only suppress HBV replication, thus requires patients to take lifelong medications.

As research into epigenetic regulatory mechanisms has advanced, these related pathways have emerged as new therapeutic targets for HBV treatment. EPI-003, an antiviral agent with a novel mechanism of action, has demonstrated notable advantages in preclinical studies. Prepared as mRNA encoding the epigenetic modulation protein and a guide RNA targeting HBV specific gene, and encapsulated in a delivery system called lipid nanoparticle (LNP) , EPI-003 is designed to make specific epigenetic modification on the HBV genome. Research indicates that EPI-003 can directly block the transcription of HBV cccDNA and integrated DNA, therefore effectively and sustainably reduce HBV surface antigen (HBsAg) and HBV DNA levels without rebound in preclinical studies. EPI-003 holds the potential to provide a functional or even complete cure for patients with chronic HBV infection.

"We are very pleased to receive the global first CTA approval of EPI-003, a liver-targeted anti-HBV epigenetic inactivator discovered by Epigenic's proprietary epigenetic regulation technology (EPIREG^®), to initiate first-in-patient evaluation of EPI-003. The approval is a significant milestone for the company which represents Epigenic's capability to pioneer epigenetic discovery and commitment to bringing innovation to transformative therapy. We will work closely with clinical investigators to accelerate clinical development on EPI-003 in order to benefit the CHB patients as soon as possible."said Bob Zhang, CEO and Co-founder of Epigenic Therapeutics.