November 2, 2013
New Preclinical Data Being Presented at The Liver Meeting 2013
NEW HAVEN, Conn., Nov. 2, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced a poster presentation detailing the preclinical profile of ACH-3422, a uridine-analog nucleotide prodrug being advanced for the potential treatment of chronic hepatitis C viral infection (HCV). The poster is being presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2013) in Washington D.C.
The poster presentation, entitled, "Preclinical Characteristics of ACH-3422: A Potent Uridine Nucleotide Prodrug for Inhibition of Hepatitis C Virus NS5B RNA Polymerase," (Poster 475; HCV Therapy: The Developmental Pipeline. Saturday, November 2, 2013: 2:00 PM — 7:30 PM ET. Poster Hall), details the potent and specific inhibition of HCV NS5B polymerase by ACH-3422, and the demonstrated low risk for mitochondrial toxicity based upon in vitro studies with human cells in static and proliferating conditions, and high efficiency in the conversion of ACH-3422 into the triphosphate within human hepatocyte cell lines. These attributes, combined with the previously reported 14-day animal toxicity study of ACH-3422, continue to support the advancement of this compound toward clinical studies for use in combination with other direct acting antiviral agents for the potential pan-genotypic treatment of chronic HCV.
"These data provide additional insight into the compelling profile of ACH-3422 as a potential NS5B nucleotide inhibitor for the broad treatment of HCV. Based upon our current development timelines, we anticipate initiating our first-in-human and proof-of-concept trials with ACH-3422 during the first half of 2014," commented Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "We believe that the ability to potentially combine a potent nucleotide, such as ACH-3422, with our other proprietary assets, including our differentiated Phase 2 NS5A inhibitor, ACH-3102, and our Phase 2 protease inhibitors, including ACH-2684, provides extensive optionality for developing a simple and effective all-oral treatment regimen aimed at curing HCV across broad treatment populations."
A reprint of the poster presentation can be accessed from the Resources section of our website at http://www.achillion.com.
ACH-3422 is a small-molecule, nucleotide prodrug inhibitor of HCV NS5B polymerase. In vitro, ACH-3422 has demonstrated excellent potency, with activity demonstrated across all genotypes of HCV and an EC50 of approximately 50 to 65 nanomolar against genotype 1 HCV. To date, Achillion has completed 14-day safety studies in animals, where no significant findings were noted at the highest dose tested. ACH-3422 appears to have high oral bioavailability, rapid uptake and conversion of the prodrug into the monophosphate within the liver, and a pharmacokinetic profile supportive of once-daily dosing. Manufacturing and preclinical studies to support clinical development have been initiated, with the expectation of beginning first-in-human studies during the first half of 2014.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's discovery, clinical development, and commercial teams have advanced multiple novel product candidates with proven mechanisms of action into studies and toward the market. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Cautionary Note Regarding Forward-Looking Statements
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 important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the potential favorable potency, safety, efficacy and other attributes of ACH-3422 and its potential benefits when used in combination with other direct acting antiviral agents to treat HCV; and the Company's plans and timing for progressing ACHN-3422 into clinical development. We may use words such as "expect," "anticipate," "project," "intend," "plan," "believe," "seek," " estimate," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: demonstrate in any potential future clinical trials the requisite safety, efficacy and combinability of ACH-3422; advance the preclinical and clinical development ACH-3422 and its other drug candidates, including ACH-3102, and ACH-2684, under the timelines it projects in current and future clinical trials; satisfactorily respond to the clinical hold placed on sovaprevir by the FDA; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2013 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.