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April 10, 2014 12:00 am ET

Clinical Findings Support Initiation of C-EDGE Phase 3 Program

Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today announced interim results from the ongoing C-WORTHy study,
a multi-arm Phase 2 clinical trial evaluating the efficacy and safety of
an all-oral, once-daily regimen combining MK-5172, an investigational
hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an
investigational HCV NS5A replication complex inhibitor, among patients
with chronic HCV Genotype 1 infection (GT1). Interim analysis of
hard-to-cure¹ patients administered MK-5172/MK-8742 with and
without ribavirin (RBV) for 12 or 18 weeks showed sustained viral
response² (SVR), 4 to 8 weeks after the completion of therapy
(SVR4/8):

• HCV GT1 infected, treatment-naïve cirrhotic patients, MK-5172/MK-8742
  treated – 97 percent (28/29 and 29/30) for 12 and 18 weeks, and
  MK-5172/MK-8742 plus RBV – 90 percent (28/31) and 97 percent (30/31)
  for 12 and 18 weeks, respectively.
• HCV GT1 infected prior-null responder patients (with or without
  cirrhosis), MK-5172/MK-8742 treated – 91 percent (30/33) and 97
  percent (29/30) for 12 and 18 weeks, respectively, and MK-5172/MK-8742
  plus RBV treated 94 percent (30/32) and 100 percent (32/32) for the 12
  and 18 weeks, respectively.
• Treatment-naïve, non-cirrhotic patients with HCV/HIV co-infection,
  MK-5172/MK-8742 treated for 12 weeks – 90 percent (26/29) and
  MK-5172/MK-8742 plus RBV for 12 weeks 97 percent (28/29).

These data were presented at the 49th Annual Meeting of the European
Association for the Study of the Liver (EASL), also known as The
International Liver Congress™ 2014 in London, UK.

“There is still a need for further options for the most
difficult-to-cure patients, including those with cirrhosis and HCV/HIV
co-infection,” said Dr. Eric Lawitz, MD, vice president, Scientific and
Research Development, The Texas Liver Institute, and clinical professor
of medicine, University of Texas Health Science Center in San Antonio.
“These findings provide additional clinical evidence regarding the
potential of MK-5172/MK-8742 in treating a broad spectrum of HCV
patients.”

C-WORTHy Study Design

C-WORTHy is a randomized, dose-responsive, parallel-group,
multiple-site, double-blind clinical trial comparing different patient
populations exposed to different durations of treatment of MK-5172 (100
mg once daily) in combination with MK-8742 (50 mg once daily) with or
without RBV in subjects with chronic HCV infection. A total of 471
patients with chronic HCV GT1 and HCV RNA levels of ≥10,000 IU/mL were
enrolled in C-WORTHy and randomized across 16 arms. These results
examine hard-to-cure subpopulations, including treatment-naïve patients
with liver cirrhosis (12- and 18-week arms, with and without RBV),
prior-null responder patients with and without cirrhosis (12- and
18-week arms, with and without RBV) and patients with HIV/HCV
co-infection (12-week arms).

Key Findings for MK-5172/MK-8742

Viral suppression (HCV RNA levels less than 25 IU/mL) was demonstrated
for treatment-naïve patients with cirrhosis, prior-null responder
patients with and without cirrhosis and HIV/HCV co-infected patients by
Treatment Week (TW)12. These levels were maintained at rates between 90
and 100 percent across patient subgroups through the completion of
dosing and at the four-week treatment follow-up time point (FU4).

The most common adverse events observed among treatment-naïve patients
with cirrhosis and prior-null responder patients with and without
cirrhosis were fatigue (23% and 28%, respectively), headache (24% and
24%, respectively), and asthenia (8% and 19%, respectively). The most
common adverse events observed among HIV co-infected patients were
headache (8%), asthenia (8%), fatigue (7%), and sleep disorder (7%).
There were no early discontinuations due to drug-related adverse events
and no clinically significant abnormalities observed in routine
laboratory analysis of hematologic markers.

About Merck’s Phase 3 HCV Program: C-EDGE

Based on the results of the Phase 2 clinical program, Merck has
initiated Phase 3 clinical trials for MK-5172/MK-8742. The Phase 3
program, called C-EDGE, will evaluate the safety and efficacy of
MK-5172/MK-8742 with and without ribavirin in various genotypes and
across a broad range of patient populations with chronic HCV. Study
cohorts will include: C-EDGE TN (GT1, GT4-6; treatment-naive ±
cirrhosis), C-EDGE CO-INFXN (GT1, GT4-6; treatment-naive ±
cirrhosis with HIV/HCV co-infection), C-EDGE RECOVERY (GT1,
GT4-6; treatment-naive ± cirrhosis; ± HIV/HCV co-infection on opiate
substitution therapy), and C-EDGE TE (GT1, GT4-6; prior failed
treatment with peginterferon/ribavirin; ± HIV/HCV co-infection). Study
information can be found at www.clinicaltrials.gov.

Merck’s Commitment to HCV

For more than 25 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 healthcare
solutions that support people living with HCV worldwide.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside of the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care 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
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com
and connect with us on Twitter,
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Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’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; Merck’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 Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck 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 Merck’s 2013 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 Defined as treatment-naïve patients with liver cirrhosis,
prior-null responder patients with and without cirrhosis and patients
with HIV/HCV co-infection

² Defined as HCV RNA below the limit of quantification or
below the limit of detection at the last visit on record – 4, 8, 12, or
24 weeks after the completion of therapy

Merck
Media Contacts:
Caroline Lappetito, 267-305-7639
Sarra Herzog, 201-669-6570
or
Investor Contacts:
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Justin Holko, 908-423-5088