Benzinga | Mar 4, 2021 07:33AM EST

Dicerna Announces Roche's Initiation of GalXC RNAi Candidate RG6346 in Phase 2 Combination Trial for Treatment of Chronic Hepatitis B Virus Infection

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(tm) 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.

"Currently available therapies fall short of the ultimate goal of providing patients with a functional cure for chronic HBV, which claims the lives of more than 880,000 people worldwide each year," said Shreeram Aradhye, M.D., Executive Vice President and Chief Medical Officer at Dicerna. "To date, data have shown that RG6346's novel GalXC RNAi gene silencing mechanism has resulted in deep and durable reductions in hepatitis B surface antigen up to one year from last dose, suggesting the potential for strong synergy as part of a combination treatment regimen. Roche's Phase 2 platform trial is the first of its kind to assess five different combinations including RG6346. We believe that a multi-modality approach that includes RG6346 holds significant promise for a functional cure for people living with HBV."

"We are very encouraged by the results from the Phase 1 trial of RG6346, which have shown a strong and sustained reduction in the levels of hepatitis B surface antigen," commented John Young, Global Head of Infectious Diseases at Roche Pharmaceutical Research and Early Development. "By including RG6346 along with other agents with novel mechanisms, we are confident that we have designed a Phase 2 study that will advance understanding of the disease pathways that underlie HBV infection and bring us closer to a potentially curative regimen."

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(r) (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.