Epigenic Therapeutics, a Chinese biotechnology company developing next-generation gene modulation therapy, announced on Tuesday that it has received clinical trial application (CTA) approval 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, an investigational, liver-targeting antiviral therapy for chronic hepatitis B virus infection.

EPI-003 is set to become the world's first epigenetic therapy to reach clinical trials for this widespread infectious disease. It 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.

This first-in-human study is intended to evaluate 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.

Bob Zhang, Epigenic Therapeutics' CEO and co-founder, said: "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."