Esperion Therapeutics (ESPR) Says Pivotal Phase 3 LDL-C to Include Patients on Any Statin, at Any Dose
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Esperion Therapeutics, Inc. (Nasdaq: ESPR) announced the bempedoic acid global pivotal Phase 3 LDL-C lowering clinical development program 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.
Top-line results from 1002-035 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.
“With the positive clinical results of bempedoic acid added to high-dose statins, and following engagement with global regulatory agencies, we are pleased to include in our ongoing global Phase 3 program patients with elevated LDL-C levels inadequately treated with current lipid-modifying therapies, including patients on any statin at any dose,” said Tim Mayleben, president and chief executive officer of Esperion Therapeutics. “Bempedoic acid has demonstrated consistent LDL-C lowering efficacy, safety, and tolerability in completed Phase 1 and Phase 2 studies, including most recently in combination with high-dose statins. 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.”
Global Pivotal Phase 3 CLEAR LDL-C Lowering Program
Prior to year-end, Esperion plans to initiate three global pivotal Phase 3 Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen (CLEAR) LDL-C lowering efficacy studies – 1002-046, 1002-047, and 1002-048 – in patients with hypercholesterolemia who are inadequately treated with current lipid-modifying therapies.
The LDL-C lowering studies will include patients on optimized background lipid-modifying therapy, including maximally tolerated statin therapy, with LDL-C levels of ≥130 mg/dL for patients without atherosclerotic cardiovascular disease (ASCVD) and ≥100 mg/dL for patients with ASCVD and/or heterozygous familial hypercholesterolemia (HeFH). The CLEAR LDL-C lowering efficacy studies are designed to measure the change in LDL-C from baseline at 12 weeks. Top-line results from the global pivotal Phase 3 CLEAR LDL-C lowering program are anticipated in mid-2018. Submissions are expected in the first half of 2019 for a New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency (EMA) for an LDL-C lowering indication.
The proposed high-level global Phase 3 design details are included below, as well as updates to the design of the ongoing CLEAR Harmony long-term safety study. Additional design details for 1002-046, 1002-047, and 1002-048 will be made available when the studies initiate later this quarter.
- 1002-046: 24-week study to assess the 12-week LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus placebo in hypercholesterolemic patients (with or without ASCVD) not adequately treated with current lipid-modifying therapies. This study is designed to enroll 300 patients only able to tolerate less than the lowest approved daily starting dose of a statin and can be considered “statin intolerant.” This study is expected to initiate before year-end.
- 1002-047: 52-week study to assess the 12-week LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus placebo in hypercholesterolemic patients (with ASCVD and/or HeFH) not adequately treated with current lipid-modifying therapies. This study is designed to enroll approximately 750 patients and is expected to initiate before year-end.
- 1002-048: 12-week study to assess the LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus placebo in hypercholesterolemic patients (with or without ASCVD) when added to ezetimibe. This study is designed to enroll approximately 225 patients and is also expected to initiate before year-end.
- CLEAR Harmony (1002-040): Initiated in January 2016, CLEAR Harmony is a 52-week, long-term safety study designed to enroll hypercholesterolemic patients (with ASCVD and/or HeFH) who are not adequately treated with current lipid-modifying therapies. At initiation, this study included 900 patients, but has been expanded to 1,950 patients to further support the Company’s expected first half 2019 regulatory submission for an LDL-C lowering indication. As a result of the expanded enrollment, top-line results for CLEAR Harmony are now expected by mid-2018.
The global Phase 3 LDL-C lowering efficacy studies are designed to support a broad label for the use of bempedoic acid for LDL-C lowering in hypercholesterolemic patients (> 100 mg/dL) who are inadequately treated with current lipid-modifying therapies. In Europe, it is expected that there would be specific language included within the label for the use of bempedoic acid in patients who are considered “statin intolerant.”
Phase 2 (1002-035) and Phase 1 (1002-037) Clinical Results Summary
The Phase 2 PK/PD eight-week, U.S.-based, multi-center, randomized, double-blind, parallel group clinical study (1002-035) evaluated 68 patients on stable atorvastatin 80 mg per day. All patients in the study received atorvastatin 80 mg for four weeks. Patients were then randomized to receive either bempedoic acid 180 mg, or placebo, for four weeks. The primary objectives of the study were to assess the LDL-C lowering efficacy of bempedoic acid versus placebo on a background of atorvastatin 80 mg, as well as multiple-dose plasma PK of atorvastatin 80 mg alone and in combination with bempedoic acid. Secondary objectives included assessment of the effect of bempedoic acid on lipid and cardiometabolic biomarkers, including hsCRP; and characterization of the tolerability and safety of bempedoic acid.
Top-line results from 1002-035 demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering of 22 percent (p=0.0028) from baseline with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. There was a 13 percent reduction in LDL-C in the bempedoic acid group and a nine percent increase in LDL-C in the placebo group when added to background 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.
The Company also announced positive top-line results from its Phase 1, open-label, clinical pharmacology study (1002-037) to assess the PK levels in healthy volunteers receiving single doses of the highest doses of the most commonly prescribed statins – atorvastatin 80 mg, rosuvastatin 40 mg, simvastatin 40 mg and pravastatin 80 mg – when added to steady-state bempedoic acid 180 mg. The PK profiles demonstrated in 1002-037 were consistent with those seen in previous studies conducted with bempedoic acid, and did not increase with the highest doses of the statins tested in combination with bempedoic acid. Together, with the results of 1002-035, these data support enrollment of patients with hypercholesterolemia on any statin at any dose in the global pivotal Phase 3 CLEAR LDL-C clinical development program.
Conference Call and Webcast Details
Esperion's management will host a conference call to discuss these updates. The call can be accessed by dialing (877) 831-3840 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing access code 98706260. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the Esperion website at investor.esperion.com, along with slides to accompany this update. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the Company's website for two weeks.
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