Obeticholic acid flops in phase 3 trial for compensated NASH-related cirrhosis
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Obeticholic acid failed to demonstrate superiority to placebo for improving fibrosis in patients with compensated cirrhosis due to nonalcoholic steatohepatitis in a phase 3 trial, according to an Intercept Pharmaceuticals press release.
“Achieving statistical significance on a histology endpoint in compensated cirrhosis due to NASH has proven to be an extremely high bar in clinical trials and underscores the importance of treating liver fibrosis due to NASH before it progresses to cirrhosis,” Michelle Berrey, MD, MPH, president of research and development and chief medical officer of Intercept, said in the release.
Researchers evaluated the safety and efficacy of obeticholic acid (OCA) in the phase 3 REVERSE study of 919 patients with compensated cirrhosis due to NASH, with the primary endpoint of histologic improvement (≥ 1 stage) in fibrosis without NASH worsening within 18 months of therapy. Patients were randomized to receive 10 mg OCA once daily, 10 mg OCA titrated to 25 mg after 3 months or placebo.
At study conclusion, the researchers observed that the drug failed to achieve statistical significance: Only 11.1% of patients who received 10 mg OCA daily achieved a 1-stage improvement in fibrosis with no worsening of NASH, compared with 11.9% of patients who received 10-25 mg OCA and 9.9% of patients who received placebo.
However, the researchers did observe a positive impact on liver stiffness, as defined by transient elastography, in both 10 mg OCA and 10-25 mg OCA groups.
The most common treatment-emergent adverse events for 10 mg OCA, 10-25 mg OCA and placebo groups included pruritis (41%, 57% and 31%, respectively) and serious gallbladder-related events (1%, 1% and 0.6%).
“We remain confident in the potential role that OCA can play in liver fibrosis due to NASH and the Intercept team is focused on resubmitting our NDA in this indication based on the positive Phase 3 REGENERATE data,” Berrey said in the release.
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