Amarin up on 'positive' late-stage data in VASCEPA trial in China

 

• Amarin (NASDAQ:AMRN) jumps 23% after-hours after sharing positive top-line results from Protocol Number EDPC003R01, a Phase 3 clinical trial of Vascepa (icosapent ethyl) conducted in China by partner, Edding.
• The study, which investigated Vascepa as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint.
• The median baseline TG levels in the study were 812 mg/dL and 837 mg/dL for the patients assigned to placebo (n=123) and 4 grams per day of Vascepa (n=122), respectively.
• The Vascepa patient group showed a statistically significant median TG decrease of 19.9% (p<0.001) compared to placebo at the end of the 12 weeks.
• The study’s primary endpoint, the percent change in TG levels from baseline to week 12, was met for the 4 gram per day Vascepa dose group.
• Vascepa was well-tolerated with a safety profile similar to placebo. No treatment-related serious adverse events were seen.
• The findings are being prepared to support Edding’s dossier for seeking regulatory approval for Vascepa in China.
• https://seekingalpha.com/news/3638219-amarin-stock-rise-23-on-positive-late-stage-data-in-vascepa-trial-in-china