September 7, 2017
Esperion (ESPR) hit a grand slam with triple therapy data, submitting an NDA filing and enrollment ahead of schedule, asserts biotech expert John McCamant, editor of The Medical Technology Stock Letter.
The Phase II triple combo trial—bempedoic acid(BA)/ezetimibe combo pill plus 20mg atorvastatin (the “038” study) randomized 63 patients 2:1 to the triple combination or placebo—was wildly successful.
The triple combination resulted in a significant 64% reduction (154 mg/dL to 56 mg/dL) in LDL cholesterol from baseline compared to just a 3% reduction on placebo.
The onset of reduction was notably faster with the 3 drug combo than any single agent and the triple combination was well tolerated with no liver enzyme increases and no muscle related AEs distinguishable from placebo.