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May 12, 2014
07:03 EDTCNATConatus initiates emricasan Phase 2b trial
Conatus Pharmaceuticals announced the initiation of a Phase 2b clinical trial of its lead drug candidate, emricasan, in post-orthotopic liver transplant, or POLT, recipients with reestablished liver fibrosis post-transplant as a result of recurrent hepatitis C virus, or HCV, infection who have successfully achieved a sustained viral response, or SVR, following HCV antiviral therapy, or POLT-HCV-SVR. The placebo-controlled, double-blind trial is designed to enroll approximately 60 patients at approximately 15 planned U.S. clinical sites. Enrollment is expected to take approximately 12 months. Patients will be randomized 2:1 to receive either 25 mg of emricasan or placebo orally twice daily for 24 months and will then be followed for another month post-treatment. The primary endpoint in this exploratory proof-of-concept trial is the change in the Ishak Fibrosis Score compared with placebo. The trial will also evaluate histological markers of inflammation, key serum biomarkers, and the safety and tolerability of emricasan in the target patient population. The sponsor-open design may allow for interim data analyses and periodic disclosures on trial progress.
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October 21, 2014
09:36 EDTCNATConatus initiated with a Buy at MLV & Co.
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