April 23, 2012
NEW HAVEN, Conn., April 23, 2012 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today provided clarification with respect to end of treatment (EOT) data from segment 2 of its Phase 2a trial of ACH-1625 that was presented during the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) International Liver Congress 2012 in Barcelona, Spain on April 21, 2012.
In this study, 58 patients were randomized to receive ACH-1625 at a once daily dose of 200 mg, 400 mg, or 800 mg in combination with pegylated interferon and ribavirin (P/R) for twelve weeks. At of the time of the poster presentation, a total of 22 patients had completed 12 weeks of ACH-1625 plus P/R followed by 12 weeks of P/R as per response guided treatment (RGT.) All (22/22, or 100%) patients had undetectable levels of HCV RNA at the end of the 24 weeks of treatment.
EOT was defined in the EASL poster presentation as any patient who returned for an EOT visit, which also included those patients who withdrew from the study prior to week 12. The additional EOT data is defined as patients who achieved extended rapid virological response (eRVR) and received a total of 24 weeks of therapy consisting of 12 week of ACH-1625 plus P/R followed by 12 weeks of P/R alone.
The rapid virological response (RVR) at week 4, cEVR at week 12 and EOT results for all patients returning for an EOT visit (30 patients) presented in the poster, as well as detailed results for patients who received a total of 24 weeks of therapy consisting of 12 weeks of ACH-1625 plus P/R followed by 12 weeks of P/R alone, are provided in the table below.
|Segment 2: 12-week treatment |
|200 mg |
|400 mg |
|800 mg |
|RVR (HCV RNA < 25 IU/mL week 4), % (n)||79% (15/19)||89% (16/18) **||90% (17/19)|
|cEVR (undetectable week 12), % (n)||100% (18/18) *||94% (15/16) **||100% (19/19)|
|EOT Visit (including patients who withdrew) (undetectable) *** % (n)||86% (6/7)||69% (9/13)||100% (10/10)|
|Reasons for discontinuation include: *200 mg 1 patient withdrew for unrelated AEs at Week 5. **400 mg 1 patient withdrew consent at Week 9, 1 patient moved at Week 2, each were undetectable at the time of withdrawal; 2 patients withdrew for unrelated AEs, one before Week 4 and one before Week 12. ***EOT denominator includes only patients who returned for their end of treatment visit.|
|Patients who achieved eRVR and received 12 weeks of ACH-1625 and P/R followed by 12 weeks of P/R||200 mg||400 mg||800 mg|
|Undetectable, % (n)||100% (5/5)||100% (7/7) †||100% (10/10) †|
|† Two patients in both the 400 mg and 800 mg dose groups had week 4 RVR (HCV RNA < 25) with remaining patients below lower limit of detection.|
Michael Kishbauch, President and Chief Executive Officer, commented, "We are providing these results as we recognized that some of the data was not clear at our poster session at EASL. We remain both happy and encouraged with the continued potency of ACH-1625, including the 100% response for all patients who completed a full 24 week regimen, and we hope that this clarification provides additional transparency with respect to the ACH-1625 data."
ACH-1625 is a Phase 2 pan-genotypic 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 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has demonstrated rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. 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 of approximately 1nM. ACH-1625 has shown clinical antiviral activity against genotypes 1 and 3. Fast Track status was granted to ACH-1625 in 2012 for the treatment of chronic HCV.
The hepatitis C virus 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 including nearly 4 million people in the United States, more than twice as widespread as HIV. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that 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, and injectable route of administration.
About Achillion Pharmaceuticals
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 including hepatitis C and resistant bacterial infections. 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 important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to the potency, safety, tolerability, effectiveness and other characteristics of ACH-1625. Among the 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: replicate in later clinical trials positive results found in earlier stage clinical trials of ACH-1625 and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain 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; and raise the substantial additional capital needed to achieve its business objectives. 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, 2011 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 obligation to update any forward-looking statement, except as required by applicable law.
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