NEW HAVEN, Conn., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today reported progress on the Company's portfolio of proprietary compounds for the treatment of chronic hepatitis C (HCV) and outlined its 2014 milestones.
"We believe that we have the broad portfolio of HCV compounds necessary to succeed in achieving our primary goal of developing commercially competitive short duration therapies for the treatment of HCV that are once-daily and ribavirin-free. With the emerging safety and in vitro data on ACH-3422, a uridine nucleotide inhibitor of NS5B polymerase, and the 12-week clinical activity reported with ACH-3102, our Phase 2, pan-genotypic, second-generation NS5A inhibitor, we believe that our HCV compounds are well-positioned to achieve positive results in the clinical studies we plan to initiate throughout 2014," commented Dr. Milind Deshpande, President and Chief Executive Officer of Achillion. "With our 2013 year-end cash balance projected to exceed $150 million, we believe we have sufficient capital to fund our operations into 2016 and achieve a number of value-creating milestones throughout this year with our HCV assets."
2014 Milestones
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ACH-3422: HCV Nucleotide NS5B Polymerase Inhibitor
- To date, all of the Company's preclinical studies support the advancement of ACH-3422 into clinical trials. Achillion expects to initiate a Phase 1 first-in-human trial ex-US during the second quarter of 2014, subject to regulatory approval, followed by a Phase 1 proof-of-concept trial in mid-2014. Achillion anticipates reporting initial results from HCV-infected patients in the third quarter of 2014.
- Achillion plans to initiate a pilot Phase 2 study early in the second quarter of 2014 evaluating the combination of ACH-3102, a second-generation NS5A inhibitor in Phase 2, with sofosbuvir in treatment-naive HCV patients over treatment durations of 8 weeks or less. The study aims to optimize the use of ACH-3102 in nucleotide-based regimens and to expedite the development of the combination of ACH-3102 and ACH-3422.
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ACH-3422 + ACH-3102 ± NS3/4A protease inhibitor
- Achillion anticipates the initiation of an all-oral Phase 2 combination study evaluating ACH-3422 by year-end 2014, and anticipates the initiation of a Phase 2 combination study evaluating ACH-3422 and ACH-3102, with and without an Achillion NS3/4A protease inhibitor, in treatment-naive HCV patients over treatment durations of 8 weeks or less in early 2015.
- Achillion intends to evaluate the combination of its NS5A inhibitor ACH-3102, and next-generation NS3/4A protease inhibitor, ACH-2684, in a Phase 1 drug-drug interaction study that is expected to begin in the first quarter of 2014.
- The Company also plans to initiate a proof-of-concept study evaluating this combination in genotype 1b HCV-infected patients over a treatment duration of 8 weeks in mid-2014 to enable future combination studies.
Sovaprevir: NS3/4A Protease Inhibitor
- Achillion is preparing a complete response package on the previously disclosed sovaprevir clinical hold and anticipates a response from the FDA by the end of the first half of 2014.
- In the ongoing Phase 2 -007 trial evaluating 12-week treatment with sovaprevir, ACH-3102, and ribavirin in combination, to date all patients with chronic genotype 1b HCV infection have maintained 100% virologic response despite the presence of multiple resistant mutations at baseline in the NS5A protein. As anticipated by the viral breakthroughs previously reported in genotype 1a patients, the combination of sovaprevir and ACH-3102 is not being pursued as a treatment for chronic genotype 1a HCV infection. Achillion intends to submit these study results for presentation at a scientific conference in 2014.
"We are very pleased with the overall progress across our broad HCV portfolio. We believe that the clinical strategy outlined for 2014 will enable us to move toward delivering commercially competitive treatment regimens for HCV," commented Dr. David Apelian, M.D., Ph.D., Chief Medical Officer at Achillion. "Furthermore, with Achillion's broad portfolio of assets, we believe that the addition of an NS5B nucleotide inhibitor, such as ACH-3422, could achieve very competitive cure rates across broad patient populations with a treatment regimen of 8 weeks or less."
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 benefits and prospects for Achillion's portfolio of HCV compounds; expectations regarding clinical study results in 2014; Achillion's projected year-end cash balance, its expectations as to the period in which such cash will be available to fund its operations, and the prospects for such cash enabling it to achieve milestones; the Company's 2014 milestone goals, including with respect to advancing compounds into and through clinical development and obtaining data readouts from trials of its compounds; and its plans and timing with respect to the FDA clinical hold on sovaprevir. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "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 current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; advance the preclinical and clinical development 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-Q for the fiscal quarter ended September 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.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
Media:
Emily Johnson
Ogilvy PR
Tel. (212) 880-5316
emily.johnson@ogilvy.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Investors:
Lee Stern
The Trout Group, LLC
Tel. (646) 378-2922
lstern@troutgroup.com
