Esperion Announces Late-Breaking Oral Presentation of Final Results of Phase 3 Long-Term Safety Study of Bempedoic Acid at the European Society of Cardiology Congress
— Bempedoic Acid Achieved Additional 20% On-Treatment LDL-C Lowering on Background of Maximally Tolerated Statins —
— Study 1 (CLEAR Harmony) Provided the Largest Evidence to Date that Bempedoic Acid Is Safe when Added on to Maximally Tolerated Statins —
— Bempedoic Acid Provides Additional Oral Therapeutic Option to Safely Lower LDL-C in High-Risk ASCVD Patients Treated with Statins —
“The final data from Study 1 provide greater reassurance about the safety of bempedoic acid and reconfirm the efficacy over a longer period of time,” said Professor Ray. “Our findings – supported by other ongoing bempedoic acid studies – may very soon offer clinicians an additional oral lipid lowering agent with which to treat high-risk patients.”
New data presented today as part of the final Study 1 results showed patients on bempedoic acid who were on a maximally tolerated statin dose had significantly fewer instances of new-onset or worsening diabetes than those on placebo who were on a maximally tolerated statin dose (5.4 percent compared to 3.3 percent; p<0.02). In addition, serious AEs, including neoplasms, were balanced between the two study arms. A detailed listing of all adjudicated cardiovascular events was provided, again showing balance between the two study arms.
Details on the presentation are as follows:
Title: Late Breaking Pharmacological Science: CLEAR Harmony – Long-term safety, tolerability and efficacy of bempedoic acid vs. placebo in high cardiovascular risk patients with LDL-C above 1.8 mmol/L on maximally tolerated statin therapy
Location: Messe München,
Design of Global Pivotal Phase 3 Study 1 (1002-040)
The 52-week, global, pivotal Phase 3 randomized, double-blind, placebo-controlled, multicenter study evaluated the long-term safety and tolerability of bempedoic acid 180 mg/day versus placebo in high-risk patients with ASCVD and/or heterozygous familial hypercholesterolemia (HeFH) with LDL-C levels of at least 70 mg/dL (1.8 mmol/L) who are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statin therapy. The study was conducted at 117 sites in the U.S.,
An open-label extension study (1002-050) was initiated in early 2017 and is fully enrolled with 1,462 patients.
About Esperion's Global Pivotal Phase 3 LDL-C Lowering Program
Esperion initiated its global, pivotal, Phase 3 clinical development program in
- Two pivotal studies evaluating bempedoic acid (Studies 1 & 2) in 3,009 patients with ASCVD on maximally-tolerated statins, with top-line results reported in
May 2018, and expected in September 2018, respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 & 4) in 614 patients with ASCVD, or at a high risk for ASCVD, considered statin intolerant, with top-line results reported in May and
March 2018, respectively;
- One pivotal study evaluating the bempedoic acid / ezetimibe combination pill (053 Study) in 382 patients with ASCVD, or at high risk for ASCVD, on maximally tolerated statins, with topline results expected in
Esperion plans to submit New Drug Applications (NDAs) to the
With a targeted mechanism of action, bempedoic acid is a first-in-class, complementary, orally available, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. Similar to statins, bempedoic acid also reduces hsCRP, a key marker of inflammation associated with cardiovascular disease. Completed Phase 2 and Phase 3 studies conducted in over 4000 patients, and approximately 2,900 patients treated with bempedoic acid, have produced LDL-C lowering results of up to 30 percent as monotherapy, 48 percent in combination with ezetimibe as monotherapy, and an additional 20 percent on maximally tolerated statins.
The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. The company initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered "statin intolerant." The CVOT — known as Cholesterol Lowering via Bempedoic Acid, an ACL-inhibiting Regimen (CLEAR) Outcomes — is an event-driven, global, randomized, double-blind, placebo-controlled study expected to enroll approximately 12,600 patients with hypercholesterolemia and high CVD risk at up to 1,000 sites in approximately 30 countries.
Esperion's Commitment to Patients with Hypercholesterolemia
High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack or stroke. In the U.S., 78 million people, or more than 20 percent of the population, have elevated LDL-C; an additional 73 million people in
Esperion's mission as the
Esperion is the
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the regulatory approval pathway for the bempedoic acid / ezetimibe combination pill and bempedoic acid and the therapeutic potential of, clinical development plan for, the bempedoic acid / ezetimibe combination pill and bempedoic acid, including Esperion's timing, designs, plans and announcement of results regarding its global pivotal Phase 3 clinical development program for bempedoic acid and the bempedoic acid / ezetimibe combination pill, Esperion's timing and plans for submission of NDAs to the
Source: Esperion Therapeutics, Inc.