LAX-101: Phase III data
Top-line data from the double-blind, U.S. Phase III ANCHOR trial in 702 patients with fasting triglyceride levels of 200-500 mg/dL who were also on background statin therapy showed that once-daily 2 and 4 g oral AMR101 for 12 weeks met the primary endpoint of significantly reducing triglycerides from baseline to week 12 vs. placebo. Specifically, low- and high-dose AMR101 led to median placebo-adjusted reductions in triglyceride levels of 10.1% and 21.5%, respectively (p=0.0005 and p<0.0001). Both doses of AMR101 also met the secondary endpoint of non-inferiority to placebo in demonstrating no elevation in LDL-C, with the upper confidence boundaries for both doses below the pre-specified +6% LDL-C threshold limit (0.05% and -1.7%, respectively). Specifically, low- and high-dose AMR101 reduced LDL-C from baseline by 3.6% and 6.2%, respectively, vs. placebo (p=0.0867 and p=0.0067). ...