ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ: ESPR) has outlined its plans for Phase 3 clinical trials of its lead product candidate, ETC-1002, after receiving minutes of its end of Phase 2 trials meeting with the U.S. Food and Drug Admniistration.
Esperion says it plans multiple Phase 3 clinical trials that will include patients who can’t use today’s statin drugs to reduce the levels of low-density lipoprotein, the so-called bad cholesterol, or whose cholesterol levels don’t respond adequately to today’s statin drugs.
Esperion said that for statin intolerant patients who have a high unmet medical need, it will work with “key opinion leaders” and will continue to seek advice from global regulatory authorities on the design of the Phase 3 program. Specifics of the Phase 3 development program are anticipated to be finalized by the first half of 2016.
For patients on maximally tolerated statin therapy who require additional LDL-C lowering, Esperion will plan to conduct efficacy and long-term safety trials. FDA has encouraged the Company to initiate a cardiovascular outcomes trial promptly, which would be well under way at the time of the New Drug Application submission and review, since any concern regarding the benefit-risk assessment of ETC-1002 could necessitate a completed cardiovascular outcomes trial before approval. Esperion intends to initiate a global long-term safety study for ETC-1002 by the end of 2015.
“Our entire team is focused on delivering a Phase 3 program that will meet the approval requirements of major regulatory agencies around the world,” said Tim M. Mayleben, Esperion president and CEO. “We continue to advance toward the potential worldwide approval of ETC-1002 as a new oral, once-daily treatment option. We remain confident that patients, physicians, and payers will welcome a new, oral LDL-C lowering therapy, especially for those patients who are considered to be intolerant of statin therapy.”
In Phase 1 trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase 2 trials, the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. And in Phase 3, the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
To listen to a replay of a conference call discussing these plans, visit http://investor.esperion.com.
Esperion says medical research shows that about 10 percent of patients who are prescribed statins — 3.5 million people in the U.S. — are considered statin intolerant, and experience side effects including severe muscle pain and weakness when taking statin drugs.
More at http://www.esperion.com.