Policy & Regulation
Dicerna Touts Positive Clinical Data for Investigational Treatments RG6346 for Chronic Hepatitis B Virus and Nedosiran for Primary Hyperoxaluria
11 August 2020 - - US-based investigational ribonucleic acid interference therapeutics developer Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA) has received positive data from its Phase 1 proof-of-concept trial of RG6346, an investigational candidate for the treatment of chronic hepatitis B virus infection in development in collaboration with Roche, and from its PHYOX3 open-label trial of nedosiran, an investigational candidate for the treatment of primary hyperoxaluria, the company said.

RG6346 Phase 1 Proof-of-Concept Trial for Treatment of Chronic Hepatitis B Virus Infection
RG6346 is an investigational GalXC RNAi therapeutic candidate in Phase 1 for the treatment of chronic HBV infection.

The ongoing Phase 1 proof-of-concept trial in adults comprises three groups: Group A, a dose-ranging cohort with healthy volunteers, which was completed last year; Group B, composed of newly diagnosed participants not on any antiviral therapy who received a single dose of RG6346; and Group C, which includes participants concurrently receiving nucleoside analog therapy and four monthly doses of one of three dose levels of RG6346.

In the Phase 1 study, nine of 10 participants who received RG6346 and have completed the treatment period in Group C achieved ≥1.0 log10 IU/mL reduction in hepatitis B surface antigen (HBsAg) at Day 112 and continued in the extended follow-up period.

At Day 112, the mean reduction in HBsAg was 1.39 log10 IU/mL for the 1.5 mg/kg cohort, 1.80 log10 IU/mL for the 3.0 mg/kg cohort, and 1.84 log10 IU/mL for the 6.0 mg/kg cohort; two participants have not yet reached Day 112. Of these 10 participants who received RG6346 and completed the treatment period, six had HBsAg
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