Achillion
Pharmaceuticals, Inc. (Nasdaq: ACHN) announced the presentation of
data validating the clinical antiviral activity of one of Achillion's NS4A
antagonists, ACH-806, for the treatment of hepatitis C virus (HCV)
infection at the 42nd Annual Meeting of the European Association for the
Study of the Liver (EASL). In three separate presentations, Achillion
researchers discussed the potent antiviral activity in HCV-infected
subjects, synergy with other classes of HCV inhibitors, and the unique mode
of action of a NS4A antagonist. Achillion has shown that blocking NS4A, a
viral protein that binds to a portion of HCV protease, inhibits HCV
replication. This program is part of a collaboration and exclusive license
agreement with Gilead Sciences for the research, development and
commercialization of compounds for the treatment of chronic HCV.
In a late-breaker session on April 14th at 5:00 PM, John Pottage, M.D.,
Senior Vice President and Chief Medical Officer at Achillion, discussed
clinical data in a presentation titled, "Short-term Antiviral Activity and
Safety of ACH-806 (GS-9132), an NS4A Antagonist, in HCV Genotype 1 Infected
Individuals." The randomized, double-blind, placebo-controlled
dose-escalation trial measured the antiviral activity, safety and
pharmacokinetics of 300 mg of ACH-806 or placebo, dosed orally twice daily
as a monotherapy over 5 days. The mean change in HCV RNA (log10) at day 5
was a decrease of 0.91 from baseline for treated subjects versus an
increase of 0.05 for control subjects. Elevations in serum creatinine (a
marker of kidney function) were observed in ACH-806 treated subjects and
were reversible after completion of dosing.
"This study provides the first demonstration of human antiviral
activity of an NS4A antagonist for HCV," said Dr. Pottage. "While we and
our partner Gilead decided to discontinue development of ACH-806 based upon
the increase in serum creatinine levels, we do not believe this effect was
target-related. The antiviral activity of the compound validates NS4A as a
novel therapeutic target and therefore supports our continued work with
Gilead to identify and evaluate next-generation compounds with the same
mechanism of action."
A second presentation on April 12 at 6:30 PM, titled "In Vitro
Evaluation of Combination Treatment of ACH-806 with Interferon, VX-950 and
NM 107," was led by Mingjun Huang, Ph.D., Senior Director of Virology at
Achillion, who discussed in vitro evaluations of ACH-806 in combination
with interferon, a protease inhibitor, and a polymerase inhibitor. The data
revealed that the NS4A antagonist did not show in vitro cross-resistance
with agents from these other HCV therapeutic classes, and that NS4A
antagonism appears to have a synergistic antiviral effect in combination in
vitro with the HCV protease inhibitor VX-950 and the polymerase inhibitor
NM 107.
Finally, in a third presentation on April 12 titled "ACH-806: A Potent
Inhibitor of HCV Replication with a Novel Mechanism of Action," Dr. Huang
described the novel mechanism of action of NS4A antagonists. Achillion's
studies demonstrated that these antagonists block the formation of
functional viral replication complexes, thereby preventing HCV replication
independent of protease or polymerase inhibition.
"The high mutation rate of HCV necessitates the combination use of
drugs with complimentary mechanisms of action in order to suppress viral
resistance. Therefore, the possibility that candidates with the unique NS4A
antagonism mechanism may be complementary to protease and polymerase
inhibitors will be an important benefit in treating HCV infection," stated
Pottage.
About Hepatitis C
Hepatitis C is a viral liver disease, caused by infection with the
hepatitis C virus. Globally, it is estimated that more than 170 million
people have chronic hepatitis C, including about three million in the
United States. Chronic hepatitis C is a leading cause of cirrhosis, a
common cause of hepatocellular carcinoma, and is the leading cause of liver
transplantation in the United States.
About Achillion
Achillion is a biopharmaceutical company focused on the discovery,
development and commercialization of innovative treatments for infectious
diseases. Achillion is currently developing treatments for HIV infection,
chronic hepatitis C infection and serious hospital-based bacterial
infections.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including statements
with respect to completion and success of Achillion's preclinical studies
and clinical trials of Achillion's drug candidates. Among the factors that
could cause actual results to differ materially from those indicated by
such forward-looking statements are: unexpected regulatory actions or
delays; uncertainties relating to results of clinical trials, including
additional data relating to ongoing clinical trials; Achillion's ability to
obtain additional funding required to conduct its research, development and
commercialization activities and Achillion's dependence on its
collaboration with Gilead Sciences. These and other risks are described in
the reports filed by Achillion with the U.S. Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year ended
December 31, 2006.
All forward-looking statements reflect Achillion's expectations only as
of the date of this release and should not be relied upon as reflecting
Achillion's views, expectations or beliefs at any date subsequent to the
date of this release. Achillion anticipates that subsequent events and
developments may cause these views, expectations and beliefs to change.
However, while Achillion may elect to update these forward-looking
statements at some point in the future, it specifically disclaims any
obligation to do so.
Achillion Pharmaceuticals, Inc.
achillion