Dicerna Pharmaceuticals has dosed the first subject in a Phase I clinical trial investigating DCR-HBVS for the treatment of adults with chronic hepatitis B virus (HBV) infection.
DCR-HBVS is an experimental GalXCTM-based therapy designed for use in the treatment of HBV infection.
The DCR-HBVS-101 trial principal investigator Edward Gane said: “RNAi-based therapy has the potential to change the treatment paradigm for patients with chronic HBV infection.
“By silencing not only the S antigen but also other viral genes through a powerful and long-acting mechanism, RNAi-based therapy could tip the balance toward allowing the patient’s own immune system to mount an effective immune response.
“This approach could help eradicate HBV and remove the need for life-long therapy.”
The randomised, placebo-controlled trial intends to analyse the safety and tolerability of DCR-HBVS in normal healthy volunteers (NHVs) and in patients with non-cirrhotic chronic HBV.
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It comprises three groups, with Group A contains 30 NHVs who will receive a single ascending-dose of DCR-HBVS and will be followed for four weeks.
Group B features a single-dose phase and will include eight patients with HBV who are naïve to nucleoside analog therapy.
Patients in Group B are expected to be followed for at least 12 weeks, with dosing scheduled to begin in the third quarter of this year.
Group C of the DCR-HBVS-101 trial includes a multiple ascending-dose phase and intends to enrol 18 patients with HBV previously treated with nucleoside analogs with a follow-up period of 24 weeks or more.
Dicerna plans to start dosing Group C patients in the second quarter of this year.
The trial’s secondary endpoints are the pharmacokinetic (PK) profile of DCR-HBVS, and evaluation of preliminary pharmacodynamics (PD) and antiviral efficacy on plasma levels of hepatitis B surface antigen (HBsAg) and HBV in blood.
Proof-of-concept data from the trial is expected to be available in the second half of this year.