Shanghai-based Epigenic Therapeutics, a biotechnology company specializing in the development of novel gene modulation therapies, has announced that it has received approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and The Health and Disability Ethics Committees (HDEC) to conduct a clinical study for its investigational drug, EPI-003.
EPI-003: A Groundbreaking Approach to Chronic Hepatitis B Treatment
EPI-003 is a liver-targeting antiviral therapy for chronic hepatitis B (CHB) virus infection and is the world’s first epigenetic therapy to reach the clinical stage for this disease. The persistent presence of hepatitis B virus (HBV) covalently closed circular DNA (cccDNA) and integrated genomic DNA within the liver leads to sustained viral surface antigenemia, which is a primary challenge in curing CHB. Current antiviral treatments for hepatitis B only suppress HBV replication, necessitating lifelong medication for patients.
EPI-003’s Potential to Transform CHB Treatment
Preclinical studies have demonstrated that EPI-003 can directly block the transcription of HBV cccDNA and integrated DNA, effectively and sustainably reducing HBV surface antigen (HBsAg) and HBV DNA levels without rebound. This novel approach holds the potential to provide a functional or even complete cure for patients with chronic HBV infection, offering a significant advancement over existing treatment options.-Fineline Info & Tech
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