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Gilead
and Achillion Announce Start of Phase 1 Clinical Trial of
GS 9132, an HCV Protease Inhibitor for the Treatment of Hepatitis
C
Gilead
Sciences and Achillion Pharmaceuticals today announced that
the companies have begun dosing patients in a Phase I study
of GS 9132, also known as ACH-806. Gilead and Achillion are
investigating GS 9132, a protease
inhibitor of the hepatitis C virus for the treatment
of hepatitis C.
The Phase
I trial is a double-blind, randomized, placebo-controlled
dose-escalation study. The goal of the trial is to evaluate
the pharmacokinetics, tolerability and safety of single escalating
doses of GS 9132 in healthy volunteers. The study will take
place in the United States and will enroll approximately 20
subjects.
In
November 2004, Gilead and Achillion established an agreement
granting Gilead worldwide rights for the research, development
and commercialization of certain Achillion compounds for the
treatment of hepatitis C.
Discovered
by Achillion, GS 9132 is a small molecule inhibitor of hepatitis
C virus (HCV) replication, which works through a novel mechanism
of action involving HCV protease. Achillion completed the
initial work necessary to move the compound into clinical
development.
“Gilead
and Achillion share a commitment to advancing novel compounds
with the potential to address the unmet medical need that
exists for patients chronically infected with hepatitis C,”
said Norbert Bischofberger, PhD, Executive Vice President,
Research and Development, Gilead Sciences. “Achillion's leadership
in the early clinical development of this compound, and work
to ensure rapid progress toward the Investigational New Drug
application filing earlier this summer, has allowed us to
advance this important clinical program. We look forward
to our continued collaboration.”
“We are
excited about the novel mechanism of action of GS 9132 involving
HCV protease, and we are looking forward to establishing the
safety profile of this compound in humans,” stated Milind
Deshpande, PhD, Chief Scientific Officer of Achillion. “Gilead
has been a tremendous partner through the early part of our
agreement and we look forward to benefiting from their clinical
experience and building upon our relationship as Achillion
brings GS 9132 through proof of concept studies.”
08/24/05
Source
Gilead
Sciences. www.gilead.com
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