Achillion Pharmaceuticals, Inc.
Achillion Completes Phase 1a Trial of ACH-1625; Begins Dosing in Phase 1b Segment With HCV-Infected Patients
Achillion Pharmaceuticals, Inc. / 28.09.2009 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer / publisher is solely responsible for the content of this announcement. --------------------------------------------------------------------------- ACH-1625 Safe and Well-Tolerated in Single Ascending and Multiple AscendingDose Trial Segments NEW HAVEN, Conn., Sept. 28, 2009 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals,Inc. (Nasdaq:ACHN), a leader in the discovery and development of small moleculedrugs to combat the most challenging infectious diseases, today announced thatthe Company has completed Phase 1a of its ongoing clinical trial of ACH-1625, aprotease inhibitor for the treatment of hepatitis C virus (HCV) infection, andhas begun dosing HCV-infected patients in the Phase 1b segment of the trial. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzymenecessary for viral replication. The drug candidate was discovered and is beingadvanced by Achillion, with the objective of developing a best-in-classprotease inhibitor for treatment of HCV infection featuring potency, safety,tolerability and convenient once-daily dosing. 'We are pleased that the outstanding safety profile established in preclinicaltesting continues to be seen in this human clinical trial. ACH-1625 was safeand well-tolerated in both the single and the multiple ascending dosesegments,' stated Elizabeth A. Olek, D.O., Vice President and Chief MedicalOfficer of Achillion. 'Clinical data gathered thus far support our belief thatACH-1625 has the potential to offer convenient once-daily dosing and animproved safety and tolerability profile compared with other proteaseinhibitors being studied for the treatment of hepatitis C.' 'This first clinical trial of ACH-1625 has proceeded exactly as planned and weare quite pleased and encouraged with the results to date. The HCV-infectedcohort of the trial has begun, and we expect it should conclude within the nextfew months. We are eager to demonstrate ACH-1625's efficacy and anticipatebeing able to announce those data early next year,' added Michael Kishbauch,Achillion's President and Chief Executive Officer. About the Phase 1 ProgramThe Phase 1a/1b 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 andmultiple ascending oral doses in healthy volunteers, and oral repeat doses for5-days in subjects with hepatitis C infection. The trial is taking place inEurope and is designed to enroll at least 54 subjects, including both healthyvolunteers and HCV-infected patients. The trial is anticipated to be completedin the first quarter of 2010. Subjects in the phase 1a single ascending dose (SAD) segment of the studyreceived single doses of ACH-1625 ranging from 50 mg to 2000 mg. Subjects inthe phase 1a multiple ascending dose (MAD) segment of the study received 5 daysof ACH-1625 up to a maximal dose of 2000 mg per day. Preliminary data from the SAD and MAD trial segments demonstrate: * No serious adverse events * No clinically significant changes in vital signs, ECGs, or laboratory evaluations * Adverse events were mild and transientAbout ACH-1625ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystalstructures of enzyme/inhibitor complex. ACH-1625 is an open chain,non-covalent, reversible inhibitor of NS3 protease. In preclinical studies,ACH-1625 demonstrated high potency, unique pharmacokinetic properties and anexcellent safety profile at high drug exposures. With its rapid and extensivepartitioning to the liver, as well as high liver/plasma ratios demonstrated inpreclinical studies, Achillion believes that ACH-1625 has the potential foronce daily dosing. ACH-1625 has shown low single-digit nanomolar potency thatis specific to HCV. It is equipotent against HCV genotypes 1a and 1b atIC50~1nM. About HCVThe hepatitis C virus (HCV) is the most common cause of viral hepatitis, whichis an inflammation of the liver. It is currently estimated that more than 170million people are infected with HCV worldwide and The American Association ofLiver Disease estimates that up to 80% of individuals become chronicallyinfected following exposure to the virus. If left untreated, chronic hepatitiscan lead to permanent liver damage, which can result in the development ofliver cancer, liver failure or death. Few therapeutic options currently existfor the treatment of HCV infection. The current standard of care is limited byits specificity for certain types of HCV, significant side-effect profile, andinjectable route of administration. About AchillionAchillion is an innovative pharmaceutical company dedicated to bringingimportant new treatments to patients with infectious disease. Achillion'sproven discovery and development teams have advanced multiple productcandidates with novel mechanisms of action. Achillion is focused on solutionsfor the most challenging problems in infectious disease -- hepatitis C,resistant bacterial infections and HIV. For more information on AchillionPharmaceuticals, please visit www.achillion.com or call 1-203-624-7000. This press release includes forward-looking statements within the meaning ofthe Private Securities Litigation Reform Act of 1995 that are subject to risks,uncertainties and other factors, including statements with respect toAchillion's expectations regarding the results of ongoing clinical trials, andthe timing and duration of clinical trials. Among the factors that could causeactual results to differ materially from those indicated by suchforward-looking statements are: uncertainties relating to results of clinicaltrials, unexpected regulatory actions or delays, and Achillion's ability toobtain additional funding required to conduct its research, development andcommercialization activities. These and other risks are described in thereports 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 thedate of this release and should not be relied upon as reflecting Achillion'sviews, expectations or beliefs at any date subsequent to the date of thisrelease. Achillion anticipates that subsequent events and developments maycause these views, expectations and beliefs to change. However, while Achillionmay elect to update these forward-looking statements at some point in thefuture, it specifically disclaims any obligation to do so. ACHN-GCONTACT: Achillion Pharmaceuticals, Inc. Company Contact: Mary Kay Fenton (203) 624-7000 mfenton@achillion.com Lippert/Heilshorn & Associates, Inc. Investors: Anne Marie Fields (212) 838-3777 afields@lhai.com Bruce Voss (310) 691-7100 bvoss@lhai.com Media: Megan Rusnack (212) 838-3777 mrusnack@lhai.com News Source: NASDAQ OMX 28.09.2009 Financial News transmitted by DGAP --------------------------------------------------------------------------- Language: English Company: Achillion Pharmaceuticals, Inc. United States Phone: Fax: E-mail: Internet: ISIN: US00448Q2012 WKN: End of News DGAP News-Service ---------------------------------------------------------------------------
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