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Emricasan safely reduces HVPG, cCK18 levels in portal hypertension and cirrhosis
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Conatus Pharmaceuticals Inc. announced results from its phase 2 clinical trial of emricasan, which showed reduced levels of hepatic venous pressure gradient in patients with liver cirrhosis and severe portal hypertension and reduced cleaved Cytokeratin 18 in patients with liver cirrhosis.
The trial was conducted across nine U.S. clinical sites and enrolled 23 patients, of which 22 were evaluated, with portal hypertension and compensated liver cirrhosis mainly due to nonalcoholic steatohepatitis or HCV, according to a press release. The patients underwent treatment with 25 mg of emricasan (Conatus), an active caspase protease inhibitor, twice a day for 28 days. At baseline, 12 patients had hepatic venous pressure gradient (HVPG) greater than 12 mm Hg and 10 patients had HVPG values less than 12 mm Hg.
Overall, HVPG decreased by a mean of 3.7 mm Hg from the mean baseline of 20.6 mm Hg in the patients with HVPG greater than 12 mm Hg at baseline (P < .003). In this group of patients, eight achieved at least a 10% decrease, four achieved at least a 20% decrease and two achieved HVPG reductions below 12 mm Hg, according to the release. The changes from baseline HVPG were not statistically significant in the lower baseline HVPG group or the total evaluable patient population.
Cleaved Cytokeratin 18 (cCK18) levels were also analyzed. Among 22 patients, there was a significant reduction in cCK18 compared with baseline levels (P < .03).
The release stated that emricasan was safe and well-tolerated in the trial, with no dose-limiting toxicities and no drug-related serious adverse events.
“These results demonstrate that emricasan can cause a clinically meaningful improvement in portal hypertension in the liver cirrhosis patients who need it most,” Steven J. Mento, PhD, president and CEO of Conatus, said in the release. “We believe the results from this trial establish the near-term effects of emricasan on portal hypertension. We are [currently] evaluating emricasan's potential longer-term effects on liver function and liver structure in our other two ongoing clinical trials: the phase 2 liver cirrhosis trial and the phase 2b post-transplant trial.”
Disclosures: Mento reports being employed by Conatus.