to be presented in April at the European Association for the Study of
the Liver MeetingIsis' antisense drug targeting HBV, ISIS-HBVRx, in an
ongoing Phase 1 study planned to complete this year
CARLSBAD, Calif., March 24, 2014 /PRNewswire/ -- Isis Pharmaceuticals, Inc.
announced that treatment with 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. Isis
is currently evaluating antisense targeting of HBV with ISIS-HBVRx in a
Phase 1 study in healthy volunteers.
"Hepatitis B virus infection is a serious health problem that can lead
to significant and potentially fatal health conditions, including
cirrhosis, liver failure and liver cancer. Chronic HBV infection is one
of the most common persistent viral infections in the world. Currently
available therapies, although effective in reducing circulating HBV in
the blood, do not efficiently inhibit HBV antigen production and
secretion, which are associated with poor prognosis and increased risk
of liver cancer," said Dr. Stefan Wieland, assistant professor of
experimental virology at The Scripps Research Institute.
are encouraging as they demonstrate that antisense drugs are able to
efficiently reduce HBV-associated antigens as well as circulating HBV in
an animal model of disease. As such, these results provide support for
the development of ISIS-HBVRx for the treatment of patients with
chronic HBV infection."
These preclinical data, which will be presented by Dr. Gaetan Billioud
from The Scripps Research Institute during a presentation on April 12 at
EASL, 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.
"While chronic hepatitis B virus is currently treated with oral
antiviral agents or injectable interferons, these treatments do not
clear HBV and do not effectively clear HBV antigens from these
patients. As a result, patients are unable to fully control HBV
infection and achieve sustained disease remission. Many of these
patients are at elevated risk for severe liver complications such as
cirrhosis and primary liver cancer. By targeting and suppressing viral
mRNAs in the liver, treatment with ISIS-HBVRx added to current therapies
could result in greater viral inhibition and permit greater immune
system activity against the virus," said Richard Geary, Ph.D., senior
vice president, development at Isis. "Based on all of the preclinical
data, including the animal data that will be presented at EASL, we
initiated a Phase 1 study of ISIS-HBVRx late last year, which we plan to
complete this year."
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.
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.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its leadership position in antisense technology to
discover and develop novel drugs for its product pipeline and for its
partners. Isis' broad pipeline consists of 31 drugs to treat a wide
variety of diseases with an emphasis on cardiovascular, metabolic,
severe and rare diseases, including neurological disorders, and cancer.
Isis' partner, Genzyme, is commercializing Isis' lead product,
KYNAMRO®, in the United States and other countries for the treatment of
patients with homozygous FH. Isis' patents provide strong and extensive
protection for its drugs and technology. Additional information about
Isis is available at www.isispharm.com
Labels: antisense, drugs in development, EASL 2014, ISIS, ISIS-HBVRx