Dicerna/Roche's hep B candidate shows durable effect in early-stage study

• Dicerna Pharmaceuticals (DRNA -2.8%) has announced additional data from Phase 1 trial evaluating GalXC RNAi therapeutic RG6346, under development in collaboration with Roche for the treatment of chronic hepatitis B virus (HBV) infection. Data will be presented at the American Association for the Study of Liver Diseases.
• The results expand upon the interim results presented in August and demonstrate that four monthly doses of RG6346 treatment resulted in substantial and durable reductions in biomarkers of HBV disease activity as measured by reductions in hepatitis B surface antigen ((HBsAg)) levels lasting up to one year following the last dose. RG6346 was also shown to have a favorable safety and tolerability profile.
• 92% (11 of of the patients treated with RG6346 added to nucleos(t)ide antiviral therapy (Group C), had mean HBsAg reductions from baseline greater than 10 IU/mL by Day 112 (one month after last dose). 7 of 12 participants also achieved HBsAg levels below 100 IU/mL level that is associated with a reduced risk of progression to cirrhosis and hepatocellular carcinoma.
• After 448 days, the durability of HBsAg reductions was observed, the mean reduction in HBsAg from baseline was 25 IU/mL; one of these participants maintained  over 100 IU/mL reduction in HBsAg level from baseline at Day 448.
• https://seekingalpha.com/news/3636676-dicerna-roches-hepatitis-b-candidate-shows-durable-effect-in-early-stage-study