Achillion Announces Presentation of Data From OMEGA-1 Phase IIb Trial With Odalasvir, AL-335, and Simeprevir (JNJ-4178) at the 2017 Liver Meeting
NEW HAVEN, Conn., Oct. 23, 2017 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals (Nasdaq:ACHN) reported today Phase 2b data on JNJ-4178, the triple combination consisting of odalasvir, AL-335, simeprevir, following presentations at the 2017 Liver Meeting™ organized by the American Association for the Study Liver Diseases (AASLD), held in Washington D.C., on October 20 – 24, 2017.
SVR12 data from OMEGA-1, a global open-label Phase 2b study of the efficacy and safety of JNJ-4178 in non-cirrhotic patients with HCV genotypes 1, 2, 4, 5 and 6, were presented at the conference by Dr. Stefan Zeuzem, Professor of Medicine and Chief of the Department of Medicine I at the Goethe University Hospital, Frankfurt, Germany.
The results showed that 98.9% (181/183) of patients treated with JNJ-4178 for 6 weeks achieved SVR12, while 97.8% (178/182) of patients treated with JNJ-4178 for 8 weeks achieved SVR12, with both arms meeting the pre-specified endpoint of statistical non-inferiority compared to historic controls. The triple combination was generally well-tolerated in both arms of the study, with the most frequent adverse events being headache and fatigue. Further information on the study can be found at www.clinicaltrials.gov (NCT02765490).
Achillion announced on September 11, 2017, the termination of the worldwide license and collaboration arrangement on hepatitis C with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The notice followed the decision by Janssen to discontinue the development of the investigational hepatitis C treatment regimen JNJ-4178.
About Achillion Pharmaceuticals
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) is a science-driven, patient-focused company seeking to leverage its strengths across the continuum from discovery to commercialization in its goal of providing better treatments for people with serious diseases. The company employs a highly-disciplined discovery and development approach that has allowed it to pursue best-in-class oral antiviral therapy for chronic hepatitis C (HCV) and build a platform of potent and specific complement inhibitors. Achillion is rapidly advancing its efforts to become a fully-integrated pharmaceutical company with a goal of bringing life-saving medicines to patients with rare diseases. More information is available at http://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. Achillion may use words such as “expect,” “anticipate,” “project,” “intend,” “plan,” “aim,” “believe,” “seek,” “estimate,” “can,” “focus,” “will,” “look forward,” “goal,” and “may” and similar expressions to identify such forward-looking statements. These forward-looking statements also include statements concerning the Company’s strategic goals, milestone plans, and prospects. 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: obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third-parties; compete successfully in the markets in which it seeks to develop and commercialize its product candidates and future products; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. Furthermore, Janssen is no longer responsible for the development and commercialization of Achillion’s HCV assets under the terminated worldwide license. 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-Q for the fiscal quarter ended June 30, 2017, 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.
Investors & Media: Glenn Schulman, PharmD Achillion Pharmaceuticals, Inc. Tel. (203) 752-5510