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New HCV Drug Target NS4A Antagonists
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Achillion Presents Positive Data on Novel Mechanism for Treating HCV at EASL Annual Meeting
Press release from Achillion
16 Apr 2007
NS4A Antagonist Demonstrates Clinical Activity, a Novel Mechanism of Action and In Vitro Compatibility with other HCV Inhibitors
NEW HAVEN, CT, USA | Apr 16, 2007 | Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) today 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. For more information on Achillion Pharmaceuticals, please visit the company's web site at www.achillion.com or call Achillion at 1-203-624-7000. ACHN-G
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.
SOURCE: Achillion Pharmaceuticals, Inc.
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