Dicerna dosed the first patient in a phase 1 clinical trial for DCR-HBVS, an investigational GalXCTM-based therapy for the treatment of chronic hepatitis B, according to a press release.
“Dosing of the first patient in the DCR-HBVS-101 trial signals a major step toward our ultimate goal of developing a viable therapeutic option for patients with chronic hepatitis B virus, a serious liver infection that can result in advanced liver disease or liver cancer if not treated effectively,” Ralf Rosskamp, MD, chief medical officer of Dicerna, said in the release. “Based upon our encouraging preclinical data with DCR-HBVS and our initial experience with the healthy volunteers who are enrolled in this trial, we are optimistic about the clinical potential of RNA interference as an innovative approach to effectively treat chronic hepatitis B virus infection.”
The randomized control trial is designed to evaluate safety and tolerability of DCR-HBVS in a mix of healthy volunteers and patients with chronic HBV without cirrhosis. The researchers will also evaluate the pharmacokinetic profile and antiviral efficacy on plasma levels of HBV surface antigen and HBV DNA.
DCR-HBVS is a single GalXC molecule that targets HBV messenger RNAs within the HBsAg gene sequence region.
“Unlike other therapeutic approaches to treating chronic HBV infection, DCR-HBVS leverages the power of RNA interference to silence multiple viral genes in addition to the S antigen, potentially reducing HBsAg to very low levels, which could allow the patient’s own immune system to generate an effective immune response,” Man-Fung Yuen, DSc, MD, PhD, from the University of Hong Kong, said in the release. “With its long-acting mechanism, DCR-HBVS may help patients with chronic HBV infection achieve a functional cure.”
Dicerna anticipates proof-of-concept data in the fourth quarter of 2019.