100% SVR Demonstrated in Combination With Sovaprevir, NS3/4A Protease Inhibitor, in Late Breaker Oral Presentation
NEW HAVEN, Conn., March 14, 2014 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that two oral presentations were made at the 23rd Asian Pacific Association for the Study of the Liver (APASL) Conference 2014 in Brisbane, Australia. Updated Phase 2 clinical trial results evaluating a 150 mg loading dose followed by 50 mg once daily of ACH-3102 in combination with either once daily 200 mg or 400 mg of sovaprevir and twice daily ribavirin showed that 100% of patients achieved SVR12 (n=8) including subjects who had Y93 mutations at baseline. A second oral presentation on ACH-3102 was made at APASL 2014 that discussed clinical virology and the lack of virologic breakthrough that was observed in the novel Phase 2 clinical trial evaluating ACH-3102 with ribavirin for patients with treatment-naïve genotype 1b HCV. Despite the presence of up to six linked mutations identified at baseline in the NS5A protein, ACH-3102, without the co-administration of interferon or a second direct-acting antiviral, was able to suppress viral replication with no virologic breakthrough observed during 12 weeks of treatment.
Dr. David Apelian, M.D., Ph.D., Chief Medical Officer of Achillion, commented, "The safety, tolerability, high barrier to resistance, and clinical activity observed in these two Phase 2 trials continue to support the differentiated profile of ACH-3102, our second-generation NS5A inhibitor. As a potential cornerstone compound in genotype 1b targeted regimens, we are evaluating ACH-3102 in combination with our macrocyclic NS3/4A protease inhibitor, ACH-2684, and look forward to initiating future clinical trials for broader HCV treatment evaluating ACH-3102 in combination with our NS5B nucleotide polymerase inhibitor, ACH-3422, which is poised to enter Phase 1 trials."
Oral Presentation Details
Session: Late Breaker Oral Presentation
Title: SVR4 results for the combination of ACH-3102 and sovaprevir, with ribavirin, in subjects with genotype 1 chronic hepatitis C infection.
Presenter: David Apelian, M.D.
Date: Friday, March 14, 2014
Session: Concurrent Session
Title: ACH-3102 and ribavirin in genotype-1b hepatitis C patients: Confirmation of the high barrier to viral breakthrough in genotype-1b HCV.
Presenter: Mingjun Huang, Ph.D.
Date: Friday, March 14, 2014
Title: A single direct-acting anti-viral agent, ACH-3102, with ribavirin, is able to achieve a robust anti-viral response in subjects with genotype 1b chronic hepatitis C infection.
Authors: A. Muir, R. Brennan, et al.
Reprints of the oral presentation slides and poster will be accessible from the Achillion website at http://www.achillion.com.
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 the following: the potential benefits of ACH-3102 as an agent to treat HCV-infected patients; and our plans to initiate additional clinical trials of ACH-3102 in combination with other compounds. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," 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-3422, 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-K for the year ended December 31, 2013, filed on March 7, 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.