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
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
Wednesday, October 8, 2014 11:13 am EDT
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--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:
Presentation of MK-3682 (IDX21437) Data
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
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).
For abstracts and program information, please visit: http://www.aasld.org.
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).
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.
Read complete release here
Labels: C-SWIFT, C-Worthy, grazoprevir/elbasvir (MK-5172/MK-8742), Merck phase 2, MK-3682 (formerly IDX21437)