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Hepatitis B virus (HBV) infection is the most common and serious liver infection in the world.
the World Health Organization (WHO) estimates that there are more than 292 million people with chronic hepatitis B worldwide.
it kills more than 800,000 patients each year.
HBV is also the leading cause of liver cancer, which is the second leading cause of cancer death in the world.
existing treatments for hepatitis B can suppress the replication of HBV, but rarely achieve long-term "functional cure" effect.
is difficult to cure because HBV is able to produce co-priced closed ring DNA (cccDNA) and integrated sequences in the nucleus of infected cells.
the half-life of these sequences is very long, and current standard therapies do not effectively remove cccDNA.
RG6346 developed by Diperna to specifically knock down the genes needed for HBV mRNA production and HBV entry into cells.
In this Phase 1 clinical trial, 18 patients with chronic hepatitis B who took nucleoside (acid) (NUC) antiviral therapy were treated with different doses of RG6346 or placebo on the basis of background therapy.
patients receive RG6346 once a month for a period of 4 months.
they are eligible for long-term follow-up if their HBsAg antigen levels are reduced by more than 1.0 log10 IU/mL (1.0 log 10 equals 10 times) compared to the baseline at the end of the course.
test results showed that 11/12 (92%) of the subjects receiving RG6346 combined with NUC antiviral therapy had an average reduction of HBsAg greater than 1.0 log10 IU/mL from the baseline on the 112th day (1 month after the last RNAi was given).
HBsAg was also below 100 IU/mL in 7 (58%) of the 12 subjects.
this level is associated with a reduced risk of progression for cirrhosis and hepatocellular carcinoma.
Among subjects eligible for continued long-term follow-up, the longest follow-up patient queue (dose 1.5 mg/kg; n=3) was 448 days (1 year after the last RNAi administration) The HBsAg level of was reduced by an average of 1.40 log10 IU/mL relative to the baseline, and one of the subjects decreased by more than 2.0 log10 IU/mL relative to the baseline on the 448th day.
RG6346 significantly reduces HBsAg levels: left, a multiplied reduction of HBsAg compared to the baseline; Cerna Announces Positive Updated Data From Phase 1 Trial of RG6346 for Treatment of Chronic Hepatitis B Virus (HBV) Application at AASLD's Liver The ® Digital Experience ™ 2020. Retrieved November 16, 2020, from [2] HBV RNAi inhibitor RG6346 in Phase 1b-2a trial was safe, well-tolerated, and resulted in substantial and durable reductions in serum HBsAg levels. Retrieved November 16, 2020, from