NEW HAVEN, Conn., Jun 29, 2009 (GlobeNewswire via COMTEX News Network) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has begun dosing in a Phase I clinical trial of ACH-1625, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection.
The Phase I clinical trial is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-1625 after single and multiple ascending oral doses in healthy volunteers, and oral ascending repeat doses in subjects with hepatitis C infection. The trial will take place in Europe and is designed to enroll 54 subjects including both healthy volunteers and HCV-infected patients. Data from the trial are anticipated to be announced later this year.
ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.
"This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-1625 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "Importantly, it will also provide Achillion with preliminary efficacy data and important dose selection information for subsequent Phase II trials. We believe ACH-1625 has the potential to offer a convenient dosing schedule and an improved safety and tolerability profile compared to currently available treatments for HCV-infected patients."
"We are very excited to take ACH-1625 into the clinic to test the compound's safety and efficacy in humans," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "With its potency and safety profile in preclinical studies, and its potential for once-daily dosing, we are eager to advance what we hope will be a best-in-class candidate."
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies ACH-1625 has demonstrated potency, unique pharmacokinetic properties and a safe in vivo profile even at very high doses.
With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in vivo, Achillion believes that ACH-1625 can be dosed on a convenient schedule at a relatively low dosage. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 ~1nM. High safety margins have been established in both single ascending dose and repeat dose studies in vivo. Overall, Achillion believes the compound is well tolerated with minimal side effects.
The hepatitis C virus (HCV) is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, injectable route of administration and high cost.
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -- hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
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 Achillion's expectations regarding the results of ongoing clinical trials, timing and duration of clinical trials, Achillion's expectations regarding the release of data from ongoing clinical trials, and enforceability of patents. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion's ability to obtain additional funding required to conduct its research, development and commercialization activities along with Achillion's ability to attract and develop potential collaboration relationships. 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 fiscal year ended December 31, 2008.
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.
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SOURCE: Achillion Pharmaceuticals, Inc
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