Tune Therapeutics' TUNE-401 Receives Approval for Phase 1b Trial in Hong Kong for Chronic Hepatitis B
• Tune Therapeutics' TUNE-401, an epigenetic silencing therapy, has been approved for a Phase 1b clinical trial in Hong Kong for chronic hepatitis B (CHB).
• The trial will be led by Professor Man-Fung Yuen, focusing on the high prevalence of HBV in Asian populations and addressing the limitations of current treatments.
• TUNE-401 targets both integrated viral DNA and covalently closed circular DNA (cccDNA) to achieve a functional cure by epigenetically silencing the virus.
• Preclinical data demonstrated TUNE-401's ability to repress both cccDNA and integrated DNA in target cells and animal models, showing promise for a 'one-and-done' treatment.
Precision BioSciences' PBGENE-HBV Shows Promise in Phase 1 Hepatitis B Trial
• Precision BioSciences' PBGENE-HBV demonstrated a favorable safety profile in initial Phase 1 trial results, with no serious adverse events reported in the first cohort.
• Early data indicates substantial reduction in Hepatitis B surface antigen (HBsAg) in two of three participants after a single dose administration.
• The ELIMINATE-B trial is expanding globally, with active recruitment in Moldova, Hong Kong, and New Zealand, and plans for U.S. and U.K. expansion.
• PBGENE-HBV leverages the ARCUS platform to target and eliminate covalently closed circular DNA (cccDNA), the root cause of chronic Hepatitis B.
Positive Results from B-Clear Phase IIb Trial for Bepirovirsen in Chronic Hepatitis B Treatment
GSK plc announced promising results from the B-Clear phase IIb trial of bepirovirsen, showing potential for functional cure in chronic hepatitis B patients. The trial demonstrated sustained clearance of hepatitis B surface antigen and HBV DNA, with a Phase III trial set to begin in H1 2023.
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