New Zealand approves first clinical trial for hepatitis B epigenetic editing

Tune Therapeutics announced on Thursday that New Zealand health authorities have approved the company to conduct human trials of its experimental epigenetic editing therapy for chronic hepatitis B. This marks the first epigenetic editor being tested for an infectious disease and the second therapy aimed at modifying the hepatitis B genome to enter clinical trials. The previous month, Moldovan authorities granted Precision BioSciences clearance to initiate a clinical trial of the first gene editing treatment for HBV, as reported exclusively by Endpoints News.

These innovative therapies are anticipated to provide curative options for patients suffering from a chronic disease that has been notably resistant to a cure. Tune Therapeutics intends to evaluate its experimental therapy, TUNE-401, in adult individuals with chronic HBV. The initial clinical trial site will be overseen by Professor Ed Gane, who is affiliated with the University of Auckland and serves as the deputy director of the New Zealand Liver Unit at Auckland City Hospital.

Tune Therapeutics' approach is distinct from that of Precision BioSciences. While Precision employs a gene editing enzyme derived from algae that cuts the DNA, Tune's experimental treatment avoids cutting the DNA. Instead, it adds methyl groups, which silence viral genes at a specific site unique to the hepatitis B virus.

Both methods target HBV DNA integrated into host DNA as well as covalently closed circular DNA (cccDNA). This is significant because cccDNA, a stable ring of viral DNA, acts as a viral factory that remains hidden within cells, making the infection particularly difficult to eradicate.