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Monday, January 28, 2019

Conatus announces publication expanding on three Phase 2 clinical trials


Conatus announced publications expanding on previously reported results from three of the company’s completed Phase 2 clinical trials. Mitchell Schiffman, is the lead author on a new publication in Alimentary Pharmacology and Therapeutics detailing results from the double-blind, placebo-controlled Phase 2 NAFLD/NASH clinical trial. This trial enrolled 38 patients with nonalcoholic fatty liver disease, or NAFLD, including the subset of NAFLD patients with nonalcoholic steatohepatitis, or NASH. Patients were randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for 28 days. Top-line results from the NAFLD/NASH clinical trial were released in March 2015 and presented at The International Liver Congress, the annual meeting of the European Association for the Study of the Liver, or EASL, in April 2015. Guadalupe Garcia-Tsao is the lead author on a new publication in Hepatology detailing results from the exploratory, open-label Phase 2 Portal Hypertension clinical trial. This trial enrolled 23 patients with portal hypertension and compensated liver cirrhosis that was predominantly due to NASH or hepatitis C virus, or HCV, including patients with active HCV infection and patients who had a sustained viral response to antiviral therapy. Patients received 25 mg of emricasan orally twice daily for 28 days. Top-line results from the Portal Hypertension clinical trial were released in September 2015 and presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases, or AASLD in November 2015. Catherine Frenette is the lead author on a new publication in Clinical Gastroenterology and Hepatology detailing results from the Phase 2 Liver Cirrhosis trial. This trial enrolled 86 patients with liver cirrhosis, mild to moderate liver impairment and a model for end-stage Liver Disease, or MELD, score of 11 to 18 during the screening period. In the first phase of the trial, patients were randomized 1:1 to receive 25 mg of emricasan or placebo orally twice daily for 28 days. Top-line results from the first stage were released in January 2016 and presented at the EASL annual meeting in April 2016. In the open-label second stage, patients who completed the first stage of the trial, either on treatment or placebo, received emricasan for up to an additional three months. Top-line results from the second stage were released in May 2016 and presented at the AASLD annual meeting in November 2016.

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