Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, announced today that Roche has initiated RG6346 in a Roche-sponsored Phase 2 combination trial for the treatment of chronic hepatitis B virus (HBV) infection. RG6346 is an investigational GalXC™ RNAi therapeutic that Dicerna is developing in collaboration with Roche as part of the companies’ worldwide collaboration and licensing agreement for chronic HBV treatments. The Phase 2 platform trial will evaluate the efficacy and safety of RG6346 in combination with multiple additional agents with different mechanisms of action. Dicerna has earned a $25 million milestone in connection with the initiation of RG6346 in the Phase 2 combination trial.
The Roche Phase 2 trial (NCT04225715) is a randomized, adaptive, open-label platform trial designed to evaluate the safety, tolerability and efficacy of multiple combinations of novel agents in patients infected with chronic HBV against a common control, allowing rapid inclusion of additional treatment arms as needed. A combination of Roche’s novel investigational TLR7 agonist and core protein allosteric modulator (CpAM) inhibitor is currently already running within this study. In March 2021, RG6346 (also known as RO7445482) RNAi treatment arms have been initiated in combination with standard of care nucleos(t)ide (NUC) therapy and in triple combinations with Pegasys® (pegylated interferon alfa-2a), Roche’s CpAM inhibitor or Roche’s TLR7 agonist. The primary endpoint of the study is the percentage of participants with hepatitis B surface antigen (HBsAg) loss at 24 weeks after the end of the 48-week treatment period.
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