Amarin Corp (NASDAQ:AMRN) saw its shares soar by more than 75% on Monday after announcing that its main product candidate, triglyceride-reducing drug AMR101, achieved the primary goals of a phase three trial.
The purpose of the phase three study was to show that AMR101 is effective in reducing levels of triglycerides, a type of fat in the bloodstream, without in turn increasing LDL, or bad cholesterol, levels in patients on background statin therapy. Statin therapy is used to lower cholesterol levels.
"Whereas current triglyceride-lowering drugs may raise LDL-C and causes patient treatment concerns, AMR101 demonstrated a decrease in LDL-C beyond the decrease created by statin therapy," said the lead investigator of the trial, Dr. Christie M. Ballantyne.
High trigylcerides and cholesterol levels are associated with an increased risk of heart disease or stroke.
After 12 weeks of treatment, the company said results exceeded expectations, as triglyceride levels decreased 21.5% and 10.1% at 4 gram and 2 gram doses, respectively, from baseline compared to the placebo arm.
Moreover, for the 4 gram-per-day AMR101 group, LDL cholesterol decreased by 6.2% from baseline versus placebo, while going down by 3.6% for the 2 gram-per-day group.
The trial tested AMR101 as a treatment for high triglycerides in 702 patients on background statin therapy, who were at high risk of cardiovascular disease. 73% of the patients were diabetic.
The company said the phase three study also showed that all secondary goals were achieved, as there were significant decreases in non-HDL-C, Apo B, Lp-PLA2 and VLDL-cholesterol, all important biomarkers that represent predictors of cardiovascular risk.
In additon, the trial found that the drug had a good safety profile, with no treatment-related serious adverse events reported.