Conatus Pharmaceuticals announced positive results from the initial stage of the Phase 2 Liver Cirrhosis clinical trial which evaluated emricasan compared to placebo in patients with liver cirrhosis.
The Phase 2 Liver Cirrhosis clinical trial was a multicenter, double-blind, placebo-controlled study of 86 patients with liver cirrhosis of various etiologies. In the initial stage, patients were randomized 1:1 to receive either emricasan 25mg or placebo twice daily for 3 months. Afterwards, an open-label stage was conducted where all patients either on emricasan or placebo received emricasan treatment for additional 3 months. The primary endpoint was change from baseline in caspase-cleaved cytokeratin 18 (cCK18), a mechanism-specific biomarker of caspase-driven cell death. Secondary endpoints included changes from baseline in Model for End-stage Liver Disease (MELD) and Child-Pugh scores.
Results from the initial three-month, double-blind, placebo-controlled stage showed a statistically significant reduction in cCK18 for emricasan vs. placebo (P=0.04) in the overall patient population when adjusted for differences in baseline MELD score and disease etiology. In addition, the secondary endpoints, along with other key liver function parameters, demonstrated favorable trends vs. placebo in the overall patient population after 3 months of treatment. The study showed a 1.6 reduction in mean MELD score with emricasan vs. 0.6 increase with placebo (P=0.003) and a 0.6 reduction in mean Child-Pugh score with emricasan vs. 0.6 increase with placebo (P=0.003). Trends were driven by statistically significant improvements in a subgroup of patients with baseline MELD scores ≥15, the established prerequisite for liver transplant listing. This result is consistent with data from the Company’s Phase 2 Portal Hypertension clinical trial announced in the third quarter of 2015.
Full study results of the Phase 2 Liver Cirrhosis clinical trial are expected in the second quarter of 2016.
Emricasan is the Company’s first-in-class, orally-active pan-caspase inhibitor.
For more information visit Conatuspharma.com.