Studies focused on patients where there is a high unmet need today or anticipated in the near future
BOSTON (November 7, 2014) - Janssen R&D Ireland (Janssen)
highlights its hepatitis C (HCV) clinical development program in advance
of The Liver Meeting®, the Annual Meeting of the American Association
for the Study of Liver Diseases (AASLD), being held November 7-11, 2014
in Boston, Massachusetts.
Given the size, complexity and diversity of the HCV patient
population, physicians will continue to need multiple treatment options
and combinations in order to offer patients an opportunity for cure into
the next decade.
The Janssen HCV clinical development program includes studies that
investigate the use of simeprevir in several interferon-free regimens
using selected combinations of direct-acting antivirals with different
mechanisms of action targeting diverse patient populations. These
studies are focused on potentially offering alternative and more
immediate treatment options for physicians and patients where there is a
high unmet need today or anticipated in the near future. Ongoing
clinical studies include:
Phase 3 OPTIMIST studies examining the safety and efficacy of
simeprevir and the nucleotide analog NS5B polymerase inhibitor
sofosbuvir without interferon or ribavirin for the treatment of chronic
HCV infection for treatment-naïve and treatment-experienced patients
with and without cirrhosis.
Phase 2 IMPACT study evaluating the efficacy, safety and
pharmacokinetics of simeprevir administered once daily in combination
with sofosbuvir and the NS5A replication complex inhibitor daclatasvir
in treatment-naïve and treatment-experienced patients with HCV genotype 1
and 4 infection and decompensated liver disease.
With the closing of the acquisition of Alios Biopharma, Inc. earlier
today, Janssen now holds a platform of nucleotide analog polymerase
inhibitors, the early-clinical stage compounds AL-335 and AL-516.
"Janssen is committed to combating hepatitis C by exploring the
potential to bring forth, in a timely manner, an in-house
interferon-free combination regimen to make a difference in patients'
lives," said Gaston Picchio, Ph.D., Hepatitis disease area leader,
Read complete press release here
Labels: AASLD 2014, IMPACT, Janssen, OPTIMIST