Date: 2016-11-03
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Conatus Pharmaceuticals (USA - CA)
Product: emricasan
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.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic
area: Hepatic diseases - Liver diseases
Country: USA
Trial
details:
- The ENCORE-PH clinical trial is expected to be conducted at approximately 90 U.S. and EU clinical sites. Patients will be randomized 1:1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan, 50 mg of emricasan, or placebo twice daily for 24 weeks. The primary endpoint is the mean change from baseline in HVPG at 24 weeks for each dosing group compared with the placebo group. Key secondary endpoints include safety and tolerability, dose response, and percentage of patients achieving at least a 20% reduction in HVPG. Additional key endpoints include initial or subsequent decompensation events, changes from baseline in Model for End-stage Liver Disease (MELD) and Child-Pugh scores, and health-related quality of life. Select sites will also investigate whether emricasan improves liver stiffness as measured by Fibroscan® transient elastography and liver metabolic function using the BreathID® Methacetin Breath Test at screening and at Week 24. (NCT02960204)
Latest
news:
- • On November 3, 2016, Conatus Pharmaceuticals announced the initiation of ENCORE-PH (PH for Portal Hypertension), a randomized, double-blind, placebo-controlled, Phase 2b clinical trial evaluating emricasan, the company's first-in-class, orally-active pan-caspase inhibitor, in approximately 240 patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension confirmed by hepatic venous pressure gradient (HVPG) of ?12 mmHg at baseline. This trial is designed to evaluate dosing, efficacy and safety of emricasan in NASH cirrhosis as an integral part of the company's initial registration strategy. Top-line results from the ENCORE-PH clinical trial are expected in 2018.
- ENCORE-PH is one of the parallel EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials designed to evaluate emricasan treatment in chronic liver disease of different etiologies and disease stages. The ENCORE clinical trials are designed to provide clinically relevant efficacy, dosing, and safety data to support the initial registration of emricasan for chronic administration in patients with NASH cirrhosis and potentially support future label expansion. Results from the combined ENCORE clinical trials are expected to support the design of Phase 3 efficacy and safety trials and, depending on the strength of the efficacy and safety data, may warrant earlier discussions with regulatory agencies regarding potential accelerated approval. The ENCORE-NF clinical trial, in patients with NASH fibrosis, was initiated in January 2016. Conatus expects to initiate the remainder of the ENCORE clinical trials on a staggered basis through the first half of 2017 and expects top-line results from the ENCORE clinical trials to be available periodically beginning in the first half of 2018.
Is
general: Yes
