- Two late breaker presentations detail previously announced 100% SVR12 in Phase 2 trial evaluating 6- or 8-weeks of treatment with ACH-3102 and sofosbuvir in genotype 1 HCV patients and Phase 1 proof-of-concept results with ACH-3422 -
- Clinical virology presentation continues to support improved barrier to resistance with ACH-3102 -
VIENNA, Austria, April 25, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today presented two late breaker posters at the 50th Annual Meeting of the European Association for the Study of the Liver (EASL) during The International Liver Congress 2015.
"We believe that the ability to achieve 100% SVR12 after six-weeks of treatment with ACH-3102 and sofosbuvir supports the potential for our proprietary doublet regimen to reduce treatment duration for HCV patients," commented Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "We are also very pleased with the robust Phase 1 proof-of-concept data reported on ACH-3422, our proprietary NS5B nucleotide polymerase inhibitor, and the clinical virology presentation that continues to support the differentiated higher barrier to resistance for ACH-3102."
Data highlights from all of the presentations include:
LP06: Sustained virologic response after ACH-3102 and sofosbuvir treatment for 8 or 6 weeks: A phase 2 "proxy" study ACH102-017. ePoster Presentation, April 25, 3:30 pm CET, Hall B ePoster Area. Lead Author: Edward Gane.
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As previously reported, 100% of patients achieved SVR12 after six- (n=12) or eight-weeks (n=12) of treatment in this ongoing interferon-free, ribavirin-free study evaluating the efficacy, safety, and tolerability of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, in treatment-naïve genotype 1 HCV-infected patients.
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This represents the first study to report 100% SVR12 in patients with chronic GT-1 HCV infection using a two-drug combination for 6 weeks.
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Complete virologic responses were seen in all patients, including those who were considered harder to treat than others (i.e. GT-1a, non-CC and VL > 6 million IU/mL).
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The combination of ACH-3102 with sofosbuvir was well tolerated, with no treatment discontinuations, a low incidence of AEs, and no reported significant AEs or SAEs during the treatment and follow-up periods.
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The present study provides support for future studies which will explore the use of ACH-3102 in sofosbuvir-sparing regimens with short-treatment durations.
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In parallel, further studies will explore the combination of ACH-3102 and ACH-3422 (with and without sovaprevir, an NS3 protease inhibitor) in interferon- and ribavirin-free regimens with short treatment durations across different patient populations.
LP27: Gane, E., et al. ACH-3422, a novel nucleotide prodrug inhibitor of HCV NS5B polymerase. ePoster Presentation, April 25, 3:30 pm CET, Hall B ePoster Area. Lead Author: Edward Gane.
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As previously announced, ACH-3422 achieved dose-related virologic responses in GT-1 HCV-infected patients. In the six patients who received 700 mg once daily for 14 days, mean maximal reduction from baseline was 4.6 log10, including three patients with target not detected.
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In all healthy volunteers and patients infected with HCV who received active treatment through 700 mg once daily, ACH-3422 was well-tolerated with no treatment-related serious adverse events, adverse event-related discontinuations, or clinically significant laboratory or ECG abnormalities.
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These results support further investigation of ACH-3422 with ACH-3102, a potent NS5A inhibitor, with or without the NS3/4A protease inhibitor sovaprevir, for the treatment of different patient populations with chronic HCV infection.
P0805: Achievement of SVR12 despite the presence of HCV variants resistant to first generation NS5A inhibitors in genotype-1 hepatitis C patients after 8-week therapy of ACH-3102 in combination with sofosbuvir. ePoster Presentation, April 24, 10:00 am CET, Hall B ePoster Area. Lead Author: Wengang Yang.
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Dominant NS5A variants found at baseline conferred significant resistance to ledipasvir and daclatasvir but not to ACH-3102, highlighting the mechanism underlying the improved clinical efficacy of ACH-3102.
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The clinical efficacy of ACH-3102 is also supported by its greater potency in vitro against a spectrum of GT-1a and -1b NS5A mutants as compared to the first generation of NS5A inhibitors.
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These data support further clinical exploration of ACH-3102.
About 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 150 million people are infected with HCV worldwide including more than 5 million people in the United States. 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.
About Achillion Pharmaceuticals
Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients' lives. The Company believes that its scientific excellence, integrated capabilities and experienced team position it to successfully achieve its goal of advancing new products along the entire continuum from the bench to the patient. Achillion's pipeline is currently focused on small molecule therapeutics for infectious disease and complement-related diseases. www.achillion.com
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 without limitation statements with respect to: the potential to create shorter treatments for HCV patients and the potential therapeutic and other benefits of ACH-3422 and ACH-3102. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," "focus," "will," 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 current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; advance the preclinical and clinical development of its drug candidates, including ACH-3102, ACH-3422, and sovaprevir, under the timelines it projects in current and future clinical trials; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2014, 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.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Investors:
Clayton Robertson
The Trout Group, LLC
Tel. (646) 378-2964
crobertson@troutgroup.com
