VANCOUVER, British Columbia and DOYLESTOWN, Pa., Oct. 28, 2015 (GLOBE NEWSWIRE) –
– Arbutus Biopharma Corporation (ABUS), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), today issued an update on the company’s HBV pipeline, including plans to progress lead pipeline candidate TKM-HBV into a multi-dose Phase II study in HBV infected patients by year-end.
TKM-HBV Progressing to Phase II in HBV Infected Patients
TKM-HBV, Arbutus’ RNAi product candidate for HBV, is progressing to a Phase II multi-dosing study in HBV infected patients based on results to date from a Phase I single ascending dose study. TKM-HBV, which comprises three RNAi triggers that target all HBV transcripts, has been shown in preclinical studies to reduce all viral antigen levels as well as cccDNA. TKM-HBV’s design will target hepatitis B surface antigen (HBsAg) expression regardless of its source. The Phase I clinical trial is a randomized, single-blind, placebo-controlled study, involving single ascending doses of TKM-HBV. The study is assessing the safety, tolerability and pharmacokinetics of intravenous administration of two LNP formulations (third and fourth generation) of TKM-HBV in healthy adult subjects. In order to enable maximum TKM-HBV dose escalation, steroid premedication was added to the Phase I protocol. At this time, a maximum tolerated dose has not yet been reached and evaluation of higher doses is under consideration.