Catalyst

Slingshot members are tracking this event:

Esperion Therapeutics (ESPR) Announces Phase 2 Data Evaluating Bempedoic Acid Added to Atorvastatin in Hypercholesterolemia

Do you think this event is important to the companies below? How will it affect their stock price?

Related Companies
Importance
High Medium Low
Impact on Stocks
ESPR

100%
PFE

100%

Additional Information

Clinical Data Top-line results from 1002-035 demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering from baseline of 22 percent (p=0.0028) with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35 percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported.Phase 2 (1002-035) and Phase 1 (1002-037) Clinical Results SummaryThe Phase 2 PK/PD eight-week, U.S.-based, multi-center, randomized, double-blind, parallel group clinical study (1002-035) evaluated 68 patients on stable atorvastatin 80 mg per day. All patients in the study received atorvastatin 80 mg for four weeks. Patients were then randomized to receive either bempedoic acid 180 mg, or placebo, for four weeks. The primary objectives of the study were to assess the LDL-C lowering efficacy of bempedoic acid versus placebo on a background of atorvastatin 80 mg, as well as multiple-dose plasma PK of atorvastatin 80 mg alone and in combination with bempedoic acid. Secondary objectives included assessment of the effect of bempedoic acid on lipid and cardiometabolic biomarkers, including hsCRP; and characterization of the tolerability and safety of bempedoic acid.Top-line results from 1002-035 demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering of 22 percent (p=0.0028) from baseline with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. There was a 13 percent reduction in LDL-C in the bempedoic acid group and a nine percent increase in LDL-C in the placebo group when added to background atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35 percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported.
http://investor.espe...
Slingshot Insights Explained
Catalyst Date
Occurred on:
Oct 13, 2016
Related Projects Image
  • Don’t see a project related to the catalyst you care about?

Related Keywords Atorvastatin, Bempedoic Acid, Ldl-c Lowering, 1002-035 Study