Date: 2014-03-24
Type of information:
phase: 1
Announcement: presentation of data at the 49th annual meeting of the European Association for the Study of the Liver (EASL) by Dr. Gaetan Billioud, from the Scripps Research Institute in London, England.
Company: Isis Pharmaceuticals (USA) GSK (UK)
Product: ISIS-HBVRx, formerly referred to a ISIS-GSK3 Rx
Action mechanism: ISIS-GSK3Rx is an antisense drug designed to inhibit the production of an undisclosed target to treat a common viral infection. ISIS-HBVRx is part of Isis' alliance with GSK. Isis will develop ISIS-HBVRx to completion of Phase 2 proof-of-concept, after which GSK has an exclusive option to in-license and further develop and commercialize ISIS-HBVRx. Isis has already earned $10 million in milestone payments from GSK for ISIS-HBVRx and is eligible to earn additional pre-licensing milestone payments from GSK as ISIS-HBVRx advances in development. Isis is also eligible to receive double-digit royalties on sales of ISIS-HBVRx.
Disease: hepatitis B
Therapeutic area: Infectious diseases
Country:
Trial details: The Phase 1 study of ISIS-HBVRx is a randomized, placebo-controlled, dose-escalation study in approximately 30 healthy volunteers. This study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of ISIS-HBVRx. ISIS-HBVRx, formerly referred to as ISIS-GSK3Rx, is an investigational drug that is designed to target viral mRNA and reduce the production of viral proteins associated with HBV infection and replication.
Latest
news: * On March 24, 2014, Isis Pharmaceuticals has announced that treatment with ISIS-HBVRx (formerly referred to as ISIS-GSK3Rx),an antisense compound targeting hepatitis B virus (HBV) produced dose-dependent reductions in all measured liver and serum viral markers of HBV infection in animal models of HBV infection. These data will be presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) by Dr. Gaetan Billioud, from the Scripps Research Institute in London, England. These preclinical data, demonstrate that antisense targeting of HBV RNA could be an effective approach to treating patients with chronic HBV infection. In this study, an antisense compound targeting HBV produced dose-dependent reductions of HBV-associated antigens, including HBsAg (hepatitis B surface antigen), which is present in both acute and chronic infections and is associated with a poor prognosis in patients with chronic HBV infection. In addition, other measures of viral infection were reduced in both the liver and serum in this mouse model of disease. Isis is currently evaluating antisense targeting of HBV with ISIS-HBVRx in a Phase 1 study in healthy volunteers. * On November 26, 2013, Isis Pharmaceuticals has announced that it has initiated a Phase 1 study for ISIS-GSK3Rx and earned a $3 million milestone payment from GSK. ISIS-GSK3Rx is designed to inhibit the production of an undisclosed target to treat a common viral infection. Isis will develop ISIS-GSK3Rx to Phase 2 proof-of-concept, after which GSK has an exclusive option to in-license the program and further develop and commercialize the asset. As a part of its alliance with GSK, Isis is eligible to earn additional pre-licensing milestone payments from GSK as ISIS-GSK3Rx advances. Isis is also eligible to receive double-digit royalties on sales of ISIS-GSK3Rx.
