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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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November 15, 2015
15:37 EDTCNATConatus says emricasan abstract selected as noteworthy, sees topline data 1H18
Conatus Pharmaceuticals announced that the company's late-breaking oral presentation at the annual meeting of the American Association for the Study of Liver Diseases -- entitled "Emricasan administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension" -- was selected as one of 16 key abstracts. Conatus CEO Steven Mento remarked, "Based in part on these encouraging clinical results, we recently introduced a strategy for the initial registration of emricasan involving multiple parallel Phase 2b clinical trials, the... ENCORE trials. We expect to initiate the ENCORE trials on a staggered basis over the next 15 months and expect top-line results to be available periodically beginning in 1H18."

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