LOUISVILLE, CO–(Marketwired – May 27, 2015) – GlobeImmune, Inc. (NASDAQ: GBIM)
today announced top line results from the GS-4774 Phase 2 study in
patients with chronic hepatitis B on long term viral suppression with an
oral antiviral treatment. In this study, patients treated with the
highest dose of GS-4774 plus ongoing oral antiviral therapy (OAV) did
not show a reduction in hepatitis B surface antigen (HBsAg) at week 24,
the primary endpoint of the study, but at 48 weeks had a mean -0.17 log10 reduction of HBsAg compared with a -0.04 log10 reduction
in the OAV alone group (p=not significant). Three patients receiving
the highest dose of GS-4774 had HBsAg reductions between -0.94 and -3.89
log10 at 48 weeks. There was no difference in HBsAg
reductions between the two lowest dose groups versus the control arm at
48 weeks. Further characterization of the T cell response to GS-4774 and
association with HBsAg changes are ongoing.
GS-4774 was found to be generally safe and well tolerated, with
injection site reactions identified as the primary adverse event. Data
from this trial are expected to be submitted for future presentation and
publication.
“We believe that this first Phase 2 trial of GS-4774 in
virally-suppressed patients suggests initial biologic activity at the
highest dose tested,” said Timothy C. Rodell, M.D., FCCP, President and
CEO of GlobeImmune, Inc. “We look forward to collaborating with our
partner Gilead Sciences, Inc. to identify potential next steps for
GS-4774 in this patient population as well as to seeing the results from
the second ongoing Phase 2 trial of GS-4774 in HBV treatment-naïve
patients.”
About the 0101 TrialThe 0101 Phase 2 trial was
designed to investigate GS-4774 in combination with ongoing oral
antiviral treatment in patients with chronic HBV infection whose disease
is currently under control with an oral antiviral therapy. The 0101
trial was a multicenter, multinational trial that enrolled 178 patients
in a randomized, open-label design comparing three different doses of
GS-4774 (2YU, 10YU or 40YU, with one YU equal to 10 million yeast
cells), administered in combination with oral antiviral therapy versus
antiviral treatment alone. [www.clinicaltrials.gov; NCT01943799]
About Chronic Hepatitis B Infection and the GS-4774 Tarmogen®
Chronic
HBV is the most common serious liver infection in the world affecting
approximately 400 million people. While approximately 80% of acutely
infected patients clear the virus without treatment predominantly
through a T cell immune response, there is currently no cure for the
vast majority of chronically-infected patients. Untreated chronic HBV
infection is associated with significant increase in related diseases,
including liver cirrhosis, hepatic decompensation and liver cancer.
Mortality is also increased for patients with chronic HBV infection,
with 25-40% of patients dying from complications of liver disease.
GS-4774, exclusively licensed to Gilead Sciences, Inc., is a
therapeutic vaccine engineered to activate an HBV-specific T cell immune
response to eliminate, or clear virus from, cells containing HBV. The
GS-4774 Tarmogen expresses a fusion protein utilizing sequences of the
hepatitis B virus contained in the four major HBV genotypes worldwide.
GS-4774 is being developed to increase the HBsAg seroconversion rate or
cure, when used in combination with oral antiviral therapy.
Read complete press release hereLabels: clinical trials, Globeimmune, GS-4774