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Emricasan effective in high MELD setting
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BARCELONA — Compared with a placebo group, patients taking the pan-caspase inhibitor emricasan presented with lower MELD, Child Pugh scores and other markers, especially in the setting of a highly impaired liver, a presenter said during the Late Breaker session of the International Liver Congress.
“This study confirmed mechanism of action with consistent treatment effect of emricasan on mechanism specific and clinical biomarkers,” Catherine Frenette, MD, HCV Next Editorial Board member from Scripps Clinic, San Diego, said during her presentation. “Emricasan improved measures of liver function in patients with baseline MELD scores of 15 or greater.”
Catherine T. Frenette
Frenette reported the 3-month interim results from the 6-month, randomized, double-blind trial that included patients with evidence of cirrhosis and MELD scores between 11 and 18. Frenette and colleagues randomized patients to either emricasan (Conatus Pharmaceuticals) 25 mg twice a day or placebo twice a day. After the 3-month timepoint, patients will all receive emricasan.
At the time of reporting, Frenette said there were 38 actively treated patients and 31 placebo-treated.
“We saw consistent improvement in caspase-related biomarkers in the overall emricasan group,” Frenette said. “There were also consistent improvements in transaminase levels in the overall emricasan group.”
In this overall group, Frenette said the decreases in MELD and Child Pugh scores appeared nonsignificant until subgroup analysis was performed and it emerged that these scores were impacted most in patients with MELD of 15 or higher.
In this high MELD group, improvement in the active group vs. the placebo group were seen in MELD score (–1.6 vs. 0.6, respectively; P = .003), Child Pugh score (–0.6 vs. +0.6, respectively; P = .003), total bilirubin (–0.55 mg/dL vs. –0.06 mg/dL, respectively; P = .03), and INR (–0.14 vs. 0.06, respectively; P = .0004).
Patients with clinically worsening events were similar in both groups, as were adverse events, Frenette said.
“These results support further study of emricasan in patients with cirrhosis and liver impairment,” she said. – by Katrina Altersitz
Reference:
Frenette, C. LB05. Presented at International Liver Congress. April 13-17, 2016; Barcelona.
Disclosure: Frenette reports receiving a grant as an investigator for Conatus Pharmaceuticals.