Hot Features
Premium
Register for Free to get streaming real-time quotes, interactive charts, live options flow, and more.
what are the details?
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), today announced its third quarter 2015 unaudited financial results and provided a corporate update.
“We are excited to advance the development of our lead HBV candidate, TKM-HBV, to a Phase II, multi-dosing, clinical trial that will measure hepatitis B surface antigen (HBsAg) reduction in HBV infected patients,” said Dr. Mark J. Murray, Arbutus’ President and CEO. “We are also accelerating the development of our other promising HBV candidates, in particular, those that target cccDNA formation and core protein/capsid assembly.”
Recent Company Highlights
– Arbutus announced progression of TKM-HBV to Phase II studies in HBV infected patients based on results from a Phase I single ascending dose study. The TKM-HBV product candidate that will be studied in Phase II will be referred to as ARB-1467.
– Arbutus presented preclinical HBV data at the 2015 International Meeting on Molecular Biology of Hepatitis B Viruses, held on October 4-8, 2015. The presentations were titled: 1) “Profiling the Effects of TKM-HBV on cccDNA in Humanized Chimeric Mouse Model of HBV”; 2) “TKM-HBV, a Novel RNA Interference Treatment for Chronic Hepatitis B, Mediates Global Viral Antigen Reductions through a Well-Defined Mechanism of Action”; and 3) “Novel Inhibitors of HBV cccDNA Formation Exhibit Synergistic Effects with Nucleoside and Nucleotide Analog.”
– Arbutus announced plans to present at the 2015 American Association for the Study of Liver Diseases (AASLD) Liver Meeting held on November 13-17, 2015. The titles of Arbutus’ accepted abstracts are: 1) “TKM-HBV, a Novel RNA Interference Treatment for Chronic Hepatitis B, Rapidly Reduces Surface Antigen and other Viral Proteins in Both Intrahepatic and Peripheral Compartments”; 2) “TKM-HBV, a Novel RNA Interference Treatment for Chronic Hepatitis B, has a Complementary Mode of Action to Current Standard of Care Nucleos(t)ide Analogs”; and 3) “Development of a Direct RNA Interference Therapy for Hepatitis Delta Virus Infection.”
Upcoming Pipeline Milestones
4Q15: Initiate phase II, multi-dose efficacy study of TKM-HBV in chronically infected patients
2016: HBsAg reduction data from TKM-HBV Phase II trial (final data in 2H16)
2016: Initiate clinical immune biomarker study for CYT-003 in HBV chronically infected patients
2H16: File IND (or equivalent) for cccDNA formation inhibitor
2H16: File IND (or equivalent) for core protein/capsid assembly inhibitor
2017: Initiate combination studies including two or more Arbutus HBV product candidates
