Esperion dials up the charm as bempedoic acid heads to regs


A fourth pivotal study of Esperion’s bempedoic acid (BPA) has read out positively and seems to put to bed safety concerns, giving the company a good shot at winning approval for its cholesterol-lowering pill. Regulators remain the least of Esperion’s worries, however, and today the company accompanied the data with a charm offensive presumably aimed at investors and potential partners, both of which need convincing that BPA has a strong commercial future. On a call today executives presented a combined analysis of the four clinical trials that will form the marketing submissions; alongside encouraging efficacy readings they emphasised BPA’s lack of muscle-related adverse events and ability to improve diabetic patients’ blood sugar levels, both of which differentiate the project from statins. This latter quality could prove important commercially if Esperion can get some data on the label, although that will probably require further studies. In the meantime, finding a partner is Esperion’s biggest headache, particularly in Europe, where executives insisted that several discussions are ongoing. Fears are growing that BPA’s target market is shrinking before the company’s eyes – the PCSK9 manufacturers are slashing prices and data on Amarin’s Vascepa looms. Any interested parties will surely demand either very tempting terms or hard sales data to sign on the dotted line. 

Cumulative phase 3 results on bempedoic acid 
(Studies 1, 2, 3 and 4; n = 3,621)
LDL-C lowering at 12 wks 18% to 31%
hsCRP lowering at 12 wks 19% to 33%
HbA1c reduction 0.19% to 0.31%
3-component MACE 1.9% for BPA vs 2.3% for placebo
4-component MACE 3.8% for BPA vs 4.2% for placebo
5-component MACE 4.0% for BPA vs 4.6% for placebo
MACE = major adverse cardiovascular events; BPA = bempedoic acid. Source: company presentation.

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