Merck to Present New Data from Clinical Studies Evaluating Investigational Hepatitis C Treatment Grazoprevir/Elbasvir (MK-517...
October 08 2014 - 11:13AM
Business Wire
Interim results of C-SWIFT, a Phase 2 study
evaluating ultra-short treatment durations of grazoprevir/elbasvir
(MK-5172/MK-8742) plus sofosbuvir, to be presented
Results from the C-WORTHy study, a Phase 2
clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742)
across multiple patient populations, including difficult-to-cure,
to be presented
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that new data from clinical studies of the
company’s investigational, oral, once-daily, fixed-dose combination
chronic hepatitis C treatment grazoprevir/elbasvir
(MK-5172/MK-8742) are scheduled to be presented at the 65th
American Association for the Study of Liver Diseases (AASLD) Annual
Meeting, also known as The Liver Meeting®. The meeting is scheduled
to take place at the John B. Hynes Veterans Memorial Convention
Center in Boston, Mass., from Nov. 7 – 11, 2014.
“Tremendous progress has been made in recent years in the
understanding of chronic hepatitis C and its treatment, but it is
important that we continue to advance the development of therapies
to treat diverse populations of HCV-infected patients,” said Dr.
Eliav Barr, vice president, Infectious Diseases, Merck Research
Laboratories. “Merck’s broad and systematic hepatitis C clinical
development program is designed with this goal in mind, and is
generating important insights into the potential of
grazoprevir/elbasvir across multiple viral genotypes and patient
populations."
New data will also be presented for MK-3682 (formerly IDX21437),
an investigational oral nucleotide prodrug NS5B inhibitor acquired
earlier this year by Merck as part of its purchase of Idenix
Pharmaceuticals.
Key Presentations of
Grazoprevir/Elbasvir
Data from clinical trials evaluating grazoprevir/elbasvir will
be the subject of two oral presentations, as well as three poster
presentations, including a late-breaking abstract:
- Monday, November
10: As part of the late-breaking abstract poster session,
interim Phase 2 data from C-SWIFT, a clinical trial evaluating the
efficacy and safety of ultra-short treatment durations with
grazoprevir/elbasvir plus sofosbuvir will be presented. C-SWIFT is
the first study to report sustained viral responsei (SVR) data from
regimens as short as four weeks in genotype 1 (GT1) treatment-naïve
patients (Abstract #LB-33).
- Monday, November
10: Data from a clinical trial evaluating the health-related
quality of life (HRQOL) impact of grazoprevir/elbasvir without the
use of pegylated beta interferon (IFN) and ribavirin (RBV) versus
grazoprevir/elbasvir treatment regimens containing RBV with or
without IFN will be presented as part of a poster session (Abstract
#1455).
- Tuesday, November
11: Final results (SVR24) from the C-WORTHy Study (Parts A
and B) evaluating the efficacy and safety of grazoprevir/elbasvir
with or without RBV in GT1 infected patients will be presented
during two oral sessions.
- The first session will focus on
cirrhotic and prior null-responder patients (Abstract #196).
- The second session will focus on
mono-infected and HIV/HCV co-infected treatment-naïve,
non-cirrhotic patients (Abstract #236).
- Tuesday, November
11: Results from a study evaluating the pharmacokinetics and
safety of grazoprevir/elbasvir in patients with end-stage renal
disease (ESRD), hemodialysis (HD) or severe renal impairment (SRI)
will be presented as part of a poster session (Abstract
#1940).
Presentation of MK-3682 (IDX21437)
Data
- Tuesday, November
11: results from a Phase 1/2a study assessing seven-day
dosing of MK-3682 in subjects infected with HCV will be presented
as an AASLD presidential poster of distinction during the Hepatitis
C: Preclinical Development poster session (Abstract #1974).
For abstracts and program information, please visit:
http://www.aasld.org.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, oral, once-daily,
fixed-dose combination chronic HCV treatment, consisting of
grazoprevir (MK-5172), an investigational oral, once-daily HCV
NS3/4A protease inhibitor, and elbasvir (MK-8742), an
investigational oral, once-daily HCV NS5A replication complex
inhibitor. In October 2013, Merck announced that the U.S. Food and
Drug Administration (FDA) granted Breakthrough Therapy designation
to grazoprevir/elbasvir for treatment of chronic HCV infection.
Breakthrough therapy is intended to expedite the development and
review of a candidate that is planned for use, alone or in
combination, to treat a serious or life-threatening disease or
condition when preliminary clinical evidence indicates that the
drug may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints.
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 healthcare 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 healthcare through far-reaching policies, programs and
partnerships. For more information,
visit www.merck.com and connect with us
on Twitter, Facebook and YouTube.
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 healthcare
legislation in the United States and internationally; global trends
toward healthcare 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).
___________________________
i 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
MerckMedia:Pam Eisele, 267-305-3558Sarra Herzog,
201-669-6570orInvestors:Joe Romanelli, 908-423-5185Justin Holko,
908-423-5088
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024