Merck Advances to Part B of C-CREST Phase 2
Clinical Development Program
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the presentation of results from the
initial phase (Part A) of the company’s C-CREST 1 and 2 Phase 2
clinical development program evaluating two investigational
all-oral, triple-combination treatment regimens – a regimen of
grazoprevir1, MK-36822 and elbasvir3; and a regimen of grazoprevir,
MK-3682 and MK-84084 – in treatment-naïve patients with chronic
hepatitis C virus (HCV) genotypes (GT) 1, 2 or 3 infection. These
data will be presented today during a late-breaking abstract
session at The Liver Meeting® (Abstract #LB-15). Based on the
results of this initial trial, Merck has initiated further study of
grazoprevir (100mg), MK-3682 (450mg) and MK-8408 (60mg) in the
second phase (Part B) of the C-CREST Phase 2 clinical development
program.
“Merck’s chronic hepatitis C development program continues to
focus on the goal of advancing a short-duration treatment regimen
that offers high virologic cure rates across all viral genotypes,”
said Dr. Roy Baynes, senior vice president and head of global
clinical development, Merck Research Laboratories. “The strong
results observed in this study support the further investigation of
the novel triple-combination regimen of grazoprevir, MK-3682 and
MK-8408 in patients with chronic hepatitis C.”
In these randomized, open-label clinical trials, C-CREST 1
evaluated treatment-naive, non-cirrhotic patients with chronic HCV
GT1 or 2 infection and C-CREST 2 evaluated treatment-naive,
non-cirrhotic patients with chronic HCV GT3 infection. The primary
efficacy endpoint was sustained virologic response 12 weeks after
the completion of treatment (SVR12, or virologic cure). All 240
enrolled patients completed eight weeks of treatment and reached
follow-up 12 weeks after end of treatment. Treatment with
grazoprevir (100mg), MK-3682 (450mg) and MK-8408 (60mg), without
ribavirin (RBV), for eight weeks resulted in virologic cure rates
of greater than 90 percent across chronic HCV patients with GT1, 2
or 3 infection, which supported the decision to advance this
regimen into Part B of the C-CREST Phase 2 clinical trial
program.
Summary of SVR12 Findings Following 8
Weeks of Treatment*: C-CREST 1 and 2 Part A
Population N
Grazoprevir+ Elbasvir+
MK-3682 300mg
Grazoprevir+ Elbasvir+
MK-3682450mg
Grazoprevir+ MK-8408+
MK-3682 300mg
Grazoprevir+ MK-8408+
MK-3682 450mg
GT1 93 100% (23/23) 100% (23/23) 100%
(24/24) 91% (21/23) GT2 61 69% (11/16)
60% (9/15) 71% (10/14) 94% (15/16) GT3 86
90% (19/21) 86% (19/22) 95% (20/21) 91%
(20/22)
*Treatment-naive, non-cirrhotic
patients
The most commonly reported adverse events across all regimens
(greater than 10% incidence) were headache (23%), fatigue (20%) and
nausea (13%). There were no drug-related serious adverse events and
no discontinuations due to adverse events.
About the C-CREST Program
The C-CREST Phase 2 clinical development program is designed to
evaluate the safety and efficacy of Merck’s triple-combination
treatment regimens in patients with chronic HCV GT1, 2 or 3
infection. The investigational medicines studied in the initial
phase (Part A) of the C-CREST program included:
- Grazoprevir (MK-5172), an HCV NS3/4A
protease inhibitor
- MK-3682, an oral prodrug HCV nucleotide
analogue NS5B polymerase inhibitor
- Elbasvir (MK-8742), an HCV NS5A
replication complex inhibitor
- MK-8408, an HCV NS5A replication
complex inhibitor
Based on the results from the initial phase (Part A) in
treatment-naive, non-cirrhotic chronic HCV patients, Merck has
initiated further study of grazoprevir, MK-3682 and MK-8408 in the
second phase (Part B) of the C-CREST Phase 2 program. Part B will
evaluate the safety and efficacy of this regimen with or without
RBV in chronic HCV patients with GT1, 2 or 3 infection for
different treatment durations. The various study arms will include
treatment-naive patients with or without compensated cirrhosis or
with HIV/HCV co-infection, as well as treatment-experienced
patients (previously treated with pegylated interferon/RBV) with
GT3 infection.
Merck’s Commitment to HCV
For nearly 30 years, Merck has been at the forefront of the
response to the HCV epidemic. Merck employees are dedicated to
applying their scientific expertise, resources and global reach to
deliver innovative healthcare solutions that support people living
with HCV worldwide.
About Merck
Today's Merck is a global health care leader working to help the
world be well. Merck is known as MSD outside the United States and
Canada. Through our prescription medicines, vaccines, biologic
therapies and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to health care through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2014
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
____________________
1 Grazoprevir is an HCV NS3/4A protease inhibitor (100mg). 2
MK-3682 is an oral prodrug HCV nucleotide analogue NS5B polymerase
inhibitor (300mg or 450mg). 3 Elbasvir is an HCV NS5A replication
complex inhibitor (50mg). 4 MK-8408 is an HCV NS5A replication
complex inhibitor (60mg).
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MerckMedia:Doris Li, 908-246-5701Sarra Herzog,
201-669-6570orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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