ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ: ESPR), a pharmaceutical company focused on oral cholesterol-lowering therapies, announced the U.S. Food and Drug Administration has removed the 240 mg partial clinical hold on its drug candidate ETC-1002, bempedoic acid.
This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.
Said Tim M. Mayleben, president and CEO of Esperion. “We look forward to continuing our discussions with the FDA at next month’s End-of-Phase 2 meeting as we advance ETC-1002 through the final phase of development.”
Esperion’s product porfolio includes ETC-2001, now in late stage clinical evaluation, and two preclinical product candidates.
ETC-1002 is designed to reduce elevated levels of low-density lipoprotein, the so-called bad cholesterol, without the side effects associated with currently available LDL-cholesterol lowering therapies.
More at www.esperion.com.