Epigenic Therapeutics Announces First-in-Class Epigenetic Regulator EPI-003 Granted Clinical Trial Approval for Chronic Hepatitis B

Epigenic, a cutting-edge biotechnology company dedicated to developing next-generation innovative therapies through epigenetic regulation, announced today,The company has received clinical trial application (CTA) approval from New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committees (HDEC) to initiate the clinical trial of EPI-003.EPI-003 is an experimental and liver-targeted antiviral drug for chronic hepatitis B virus (HBV) infection.Expected to become the world's first epigenetic regulatory drug for broad-spectrum infectious diseases to enter clinical trials.

This first-in-human trial will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EPI-003 in chronic hepatitis B patients after nucleos(t)ide analog treatment. This clinical trial is planned to be conducted across multiple regions in New Zealand, Australia, and Hong Kong.

EPI-003 is a groundbreaking intravenous antiviral drug that utilizes epigenetic modification technology to target the liver for the treatment of chronic hepatitis B caused by HBV. Chronic hepatitis B is a liver disease caused by HBV infection, which can progress from an asymptomatic stage to cirrhosis, liver failure, and hepatocellular carcinoma (HCC). The main challenge in curing chronic hepatitis B is the long-term presence of HBV covalently closed circular DNA (cccDNA) and HBV DNA integrated into the genomic DNA in the liver, leading to the persistent expression of viral surface antigens. Current antiviral drug treatments for hepatitis B can only suppress HBV replication, requiring patients to take medication for life.

As research into epigenetic regulatory mechanisms continues to advance, their associated pathways have been regarded as new therapeutic targets for HBV. EPI-003, an antiviral drug with an innovative mechanism of action, has demonstrated significant advantages in preclinical studies. It is designed based on mRNA encoding epigenetic regulatory proteins and guide RNA targeting HBV-specific genes, encapsulated in a delivery system known as lipid nanoparticles (LNP), enabling precise epigenetic modification targeting the HBV genome. Studies have shown that EPI-003 can directly inhibit the transcription of HBV cccDNA and integrated DNA, exhibiting long-term and rebound-free effects in reducing HBV surface antigen (HBsAg) and HBV DNA levels.EPI-003 May Bring New Hope for Patients with Chronic Hepatitis BNew Hope for Functional and Even Complete Cure。

"We are very pleased to obtain EPI-003World's First Clinical Trial Application (CTA) Approval, this is a product developed through the unique epigenetic regulation technology (EPIREG^®) A liver-targeted anti-HBV epigenetic regulatory inhibitor developed by Epigenic Therapeutics, Inc., aimed at initiating the first patient evaluation of EPI-003. This approval represents a significant milestone for the company, showcasing its leading capabilities in epigenetic research and its ability to transform innovation into disruptive therapies. We will work closely with clinical investigators to accelerate the clinical development of EPI-003, benefiting more patients with chronic hepatitis B as soon as possible."