Achillion Pharmaceuticals, Inc. announced that it has received a $15 million milestone payment from Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), related to enrollment in the OMEGA-1 phase 2b global, clinical trial of JNJ-4178, a 3DAA combination of odalasvir, simeprevir, and AL-335 in patients with treatment-naive chronic hepatitis C virus infection (HCV) without cirrhosis.
"We are delighted to have reached this milestone following Janssen's recent initiation of the OMEGA-1 global clinical trial evaluating JNJ-4178, a once-daily combination of AL-335, simeprevir, and the Achillion-discovered NS5A inhibitor, odalasvir, and we look forward to JNJ-4178's continued clinical advancement," commented Milind Deshpande, Ph.D., president and chief executive officer of Achillion.
Initiated in November 2016, the objectives of OMEGA-1 are to investigate the efficacy, safety and pharmacokinetics of JNJ-4178 (AL-335 (800mg QD), odalasvir (25mg QD), and simeprevir (75mg QD)) in treatment-naive and treatment-experienced non-cirrhotic subjects with HCV genotype 1, 2, 4, 5, and 6 infection. A total of 300 patients are expected to be enrolled.
Patients in the study will receive the triple combination for either six or eight weeks, and the primary efficacy endpoint will be the percentage of patients with a sustained virological response 12 weeks after the end of treatment (SVR12).