- A Phase 3 clinical trial, Study 4, assessing Esperion's (NASDAQ:ESPR) bempedoic acid in statin-intolerant patients atherosclerotic cardiovascular disease (ASCVD) or at high risk of ASCVD with elevated low-density lipoprotein cholesterol (LDL-C) achieved the primary endpoint.
- Patients receiving a daily 180 mg dose of bempedoic acid for 12 weeks experienced a statistically significant 28% lowering of LDL-C compared to placebo (p<0.001) and 23% lower from baseline. Patients in the treatment group also experienced a 33% reduction in a cardiovascular disease inflammation-related biomarker called C-reactive protein compared to a 2% increase in the control group (p<0.001).
- On the safety front, bempedoic acid was well-tolerated with no difference in the occurrence of adverse events compared to placebo.
- Top-line data from two Phase 3 studies (Study 1 and Study 2) in patients with ASCVD on maximum doses of statins should be available in May and September, respectively.
- Top-line data from another study in statin-intolerant ASCVD patients, Study 3, should be available in May.
- Top-line data from another pivotal study (053 Study) assessing bempedoic acid combined with ezetimibe (Merck (NYSE:MRK)'s Zetia) in ASCVD patients on maximum statins should be available in August.
- Bempedoic acid is a small molecule that lowers cholesterol without the side effects associated with statins. Once in the liver, it converts into a derivative coenzyme which directly inhibits an enzyme called ATP citrate lyase (ACL) which plays a key role in cholesterol and fatty acid synthesis.
- Management will host a conference call this morning at 8:30 am ET to discuss the results.
- Update: Shares are up 4% premarket.
- Now read: Your Daily Pharma Scoop: Genocea Surges, Gilead's Biktarvy, GlaxoSmithKline's Vaccine Succeeds In Late-Stage Study
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