Dicerna Pharmaceuticals announced the dosing of the first volunteer in a phase 2 clinical trial of DCR-HBVS, the company’s investigational GalXCTM-based therapy for the treatment of chronic hepatitis B, according to a press release.
“The dosing of the first human in the DCR-HBVS-101 trial brings us a step closer to the potential availability of an innovative therapy for patients with chronic hepatitis B,” Ralf Rosskamp, MD, chief medical officer at Dicerna, said in the release. “We are hopeful that this three-part phase 1 trial will validate RNA interference as a viable clinical strategy against chronic hepatitis B infection, based upon our encouraging preclinical data on DCR-HBVS.”
DCR-HBVS comprises a single GalXC molecule that targets HBV messenger RNAs within the hepatitis B surface antigen gene sequence region.
The current randomized control trial was designed to evaluate the safety and tolerability of DCR-HBVS in healthy volunteers and patients with chronic HBV without cirrhosis.
“RNAi-based therapy has the potential to change the treatment paradigm for patients with chronic HBV infection,” Edward Gane, MBCHB, MD, from the New Zealand Liver Transplant Unit at Auckland City Hospital and principal investigator, said in the release. “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.”
Dicerna anticipates proof-of-concept data from the phase 1 trial in the second half of 2019.