Esperion's Oral Bempedoic Acid Passes First Phase III Cholesterol Test
'Study 4' results may support a label claim related to reducing inflammation – measured through the high sensitivity C-reactive protein (hsCRP) marker – down the line, the company told investors.
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Esperion reported positive results from the third of five Phase III studies expected to read out this year, but data for a bempedoic acid/ezetimibe fixed-dose combo expected in August may be the key to the drug's commercial future.
On top of concerns about safety, which could present regulatory hurdles, bempedoic acid is likely to face a tougher competitive environment after the decline in PCSK9 inhibitor pricing.
Phase II data on use with PCSK9 injectable support bempedoic acid's safety and efficacy profile as an add-on therapy in high cholesterol.