Achillion Pharma (ACHN) Announces Commencement of Dosing in OMEGA-1 Study Phase 2b

November 30, 2016 6:18 AM EST
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Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) announced the start of patient dosing in a global Phase 2b open-label OMEGA-1 study of JNJ-4178, a 3DAA combination of odalasvir, simeprevir, and AL-335, has been initiated by Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), in treatment-naive and treatment-experienced patients with chronic hepatitis C virus infection (HCV) without cirrhosis.

This large, international, multi-center study is expected to enroll approximately 300 HCV patients, and is part of Janssen’s global development program for JNJ-4178. Clinical trial sites are located in Europe, North America, and Asia.

The objectives of OMEGA-1 are to investigate the efficacy, safety and pharmacokinetics of JNJ-4178 (odalasvir (25mg QD), simeprevir (75mg QD), and AL-335 (800mg QD)) in treatment-naive and treatment-experienced non-cirrhotic patients with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection. Patients in the study will receive the triple combination once daily for either 6 or 8 weeks. The primary efficacy endpoint will be the percentage of patients with a sustained virological response 12 weeks after the end of treatment (SVR12).

An ongoing Phase 2a study (‘604’ study) is assessing JNJ-4178 in patients with or without compensated cirrhosis.

Further information on these trials can be found on Study identifiers NCT02765490 and NCT02569710.

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