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ESPR > phase III meets primary end point by lowering LDL-C 26%...dropout rate of 18.4% in treatment arm.

Esperion Announces Third Pivotal Phase 3 Study of Bempedoic Acid Meets Primary Endpoint

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http://www.globenewswire.com/NewsRoom/AttachmentNg/b5c19d53-31aa-443d-b97d-e0456f3248ed

http://www.globenewswire.com/NewsRoom/AttachmentNg/68cb21ac-f510-4585-9d83-a524954c903d

This study evaluated the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD), or at high risk for ASCVD with hypercholesterolemia, inadequately treated with maximally tolerated background LDL-C lowering therapy who are only able to tolerate less than the approved daily starting dose of a statin and considered statin intolerant. Importantly, these results are consistent with the previously reported results in patients considered statin intolerant.

The 24-week study achieved LDL-C lowering totaling 26 percent in patients on bempedoic acid who remained on treatment at both week 12 and week 24 (an absolute reduction of 43 mg/dL) compared with placebo which had a decrease of two percent (p<0.001). The study met its primary endpoint with LDL-C lowering of 23 percent at 12 weeks in the intent to treat (ITT) analysis (an absolute reduction of 39 mg/dL), compared with placebo which had a decrease of one percent (p<0.001). Patients treated with bempedoic acid also achieved a significantly greater reduction of 25 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, compared with placebo which had an increase of three percent (p<0.001).

Serious adverse events (SAEs) in the bempedoic acid arm were 6.0 percent compared to 3.6 percent in the placebo arm. None of the SAEs were deemed to be related to bempedoic acid by the study investigator. Discontinuations due to AEs were 18.4 percent and 11.7 percent, respectively, for the treatment and placebo groups; importantly, there was no single class of events or event that was responsible for the difference. The rate of elevations in liver function tests in this study was 0.43 percent, repeated and confirmed. This is consistent with the 0.56 percent rate observed across the entire program and with all other previously approved and successful oral LDL-C lowering therapies, including statins and ezetimibe.