Date: 2016-02-03
Type of information: Granting of a Fast Track status
Product name: emricasan
Compound: emricasan
Therapeutic area: Hepatic diseases - Liver diseases
Action mechanism: caspase converting enzyme inhibitor. Emricasan is a first-in-class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or apoptosis. In February 2016, the FDA granted Fast Track designation to the emricasan development program for the treatment of liver cirrhosis caused by NASH.
Company: Conatus Pharmaceuticals (USA - CA)
Disease: liver cirrhosis caused by NASH (non-alcoholic steatohepatitis)
Latest news:
- • On February 3, 2016, Conatus Pharmaceuticals announced that the FDA has granted Fast Track designation to emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH). Based on additional communications with the FDA recommending single-etiology clinical trials, the company plans to focus on advancing toward initial registration of emricasan for patients with NASH cirrhosis, with parallel development toward registration of emricasan for patients with NASH fibrosis, and supportive clinical trials addressing additional patient populations.
- To date, emricasan has been studied in over 650 subjects in sixteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the progression of liver disease. Recent clinical trial results have demonstrated emricasan's ability to provide statistically significant improvements in clinically important validated functional surrogate endpoints of portal hypertension and liver function across a variety of etiologies in the subgroups of liver cirrhosis patients with highest medical need. In November 2015, the company announced plans to conduct a set of parallel EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials designed to evaluate multiple doses of emricasan over various treatment durations in chronic liver disease of different etiologies and disease stages. The ENCORE trials are designed to provide further information on doses leading to clinically relevant efficacy, including improvement in biopsy-proven fibrosis and inflammation in patients with NASH fibrosis, and improvement in severe portal hypertension and hepatic function in patients with NASH cirrhosis. They are also designed to provide safety data to support the initial registration of emricasan for chronic administration in patients with liver cirrhosis.
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Is general: Yes
