Further phase 3 studies planned with novel inhibitor of cholesterol biosynthesis
24/10/2016
Based on positive results of phase 2 studies of the novel lipid-lowering agent bempedoic acid, studies will be initiated including patients with hypercholesterolaemia on any statin and any dose.
SourceNews - Oct. 25, 2016
Recently, it was announced that the Phase 3 LDL-C lowering clinical development program evaluating bempedoic acid will include patients with hypercholesterolemia on any statin at any dose, based on positive top-line results from its Phase 2 pharmacokinetics and pharmacodynamics (PK/PD) study of bempedoic acid added to atorvastatin 80 mg (1002-035), and the previously completed Phase 1 and Phase 2 studies.
Bempedoic acid is a first-in-class ACL inhibitor that reduces cholesterol biosynthesis and lowers elevated levels of LDL-C by up-regulating the LDL receptor, but with reduced potential for muscle-related side effects. Phase 1 and 2 studies conducted previously in more than 800 patients treated with bempedoic acid have produced clinically relevant LDL-C lowering results of up to 30 percent as monotherapy, approximately 50 percent in combination with ezetimibe, and an incremental 20 to 22 percent when added to stable statin therapy.
Top-line results from the phase 2 (1002-035) study demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering from baseline of 22 percent (p=0.0028) with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35 percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported.
"We believe that bempedoic acid is well-positioned as a once-daily, oral therapy for patients with hypercholesterolemia taking maximally tolerated statin therapy and/or ezetimibe who require additional LDL-C lowering, including patients considered 'statin intolerant'. We remain keenly focused on initiating both the bempedoic acid global Phase 3 efficacy program and our cardiovascular outcomes study before year-end," said Tim Mayleben, president and chief executive officer of Esperion Therapeutics.
Press release Esperion Therapeutics October 13, 2016
Bempedoic acid is a first-in-class ACL inhibitor that reduces cholesterol biosynthesis and lowers elevated levels of LDL-C by up-regulating the LDL receptor, but with reduced potential for muscle-related side effects. Phase 1 and 2 studies conducted previously in more than 800 patients treated with bempedoic acid have produced clinically relevant LDL-C lowering results of up to 30 percent as monotherapy, approximately 50 percent in combination with ezetimibe, and an incremental 20 to 22 percent when added to stable statin therapy.
Top-line results from the phase 2 (1002-035) study demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering from baseline of 22 percent (p=0.0028) with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35 percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported.
"We believe that bempedoic acid is well-positioned as a once-daily, oral therapy for patients with hypercholesterolemia taking maximally tolerated statin therapy and/or ezetimibe who require additional LDL-C lowering, including patients considered 'statin intolerant'. We remain keenly focused on initiating both the bempedoic acid global Phase 3 efficacy program and our cardiovascular outcomes study before year-end," said Tim Mayleben, president and chief executive officer of Esperion Therapeutics.
Press release Esperion Therapeutics October 13, 2016