LAX-101: Phase III data
Top-line data from the double-blind, international Phase III MARINE trial in 229 patients with fasting triglyceride levels of >=500 mg/dL showed that twice-daily 2 and 4 g oral AMR101 for 12 weeks each met the primary endpoint of significantly reducing triglycerides from baseline to week 12 vs. placebo. Specifically, low- and high-dose AMR101 reduced median triglyceride levels by 20% and 33% compared to placebo (p=0.0051 and p<0.0001, respectively). According to the trial's protocol, a p-value of 0.01 or less was required to achieve statistical significance on the endpoint.
On secondary endpoints, AMR101 significantly reduced apolipoprotein B (APOB), lipoprotein-associated phospholipase A2 ( PLA2G7; PAFAH; Lp-PLA2), very low-density lipoprotein (LDL) cholesterol and total cholesterol (p<0.05 for all), with no significant increases in median LDL-C for either AMR101 dose vs. placebo. Additionally, low- and high-dose AMR101 significantly reduced median non-HDL-C by 8% and 18%, respectively, from baseline to week 12 vs. placebo (p<0.05 and p<0.001, respectively). ...