Results of a 52 week open-label phase 2B study to assess long-term safety, immunogenicity and LDL-C efficacy of monthly dosing with LIB003 a novel anti-PCSK9 recombinant fusion protein

Abstract

Background and Aims: LIB003 (LIB) is a novel highly potent small, recombinant fusion protein with a PCSK9-binding domain (adnectin) and human serum albumin. In Phase 2 dose ranging trial mean placebo-adjusted LDL-C reductions were 77.3% with 300 mg (1.2 mL) Q4W dosing. We assessed the 52-week (Wk) safety and efficacy of LIB 300 mg Q4W in an open label extension (OLE) trial.