LIB Therapeutics’ long-term Phase 3 extension and pooled analyses of LEROCHOL® (lerodalcibep-liga) at EAS 2026 show sustained LDL-C reduction, favorable safety, and strong adherence with monthly dosing.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
At the European Atherosclerosis Society Congress 2026, LIB Therapeutics presented new long-term Phase 3 extension data for LEROCHOL® (lerodalcibep-liga). In a 72-week open-label study of 43 genetically confirmed homozygous familial hypercholesterolemia (HoFH) patients, mean LDL-C fell 19.1% (−55.7 mg/dL), accompanied by a 12.7% ApoB reduction and 20.6% median Lp(a) decline. Safety findings were limited to mild, sporadic injection-site reactions.
A separate 124-week extension study enrolled 151 participants completing prior lerodalcibep trials. Monthly 300 mg subcutaneous dosing sustained a 52% LDL-C reduction (−88.9 mg/dL) over two years, with ApoB reduced 38.9% and Lp(a) 28.7%. No treatment-related serious adverse events occurred, and no patients discontinued therapy due to adverse events. Chief Medical Officer David Kallend highlighted the high completion rate as evidence of durability, tolerability, and adherence.
Pooled Analyses: Sex and Diabetes Subgroups
Pooled Phase 3 analyses evaluated potential sex-based differences in LDL-C lowering. Investigators found that apparent sex differences largely reflected baseline LDL-C disparities rather than reduced efficacy in women. In a subgroup of 819 diabetic patients, lerodalcibep achieved placebo-adjusted LDL-C reductions of 60% at Week 52, without increased incidence of new-onset diabetes. Major cardiovascular events numerically favored lerodalcibep over placebo.
Third-Generation PCSK9 Platform
LEROCHOL represents a third-generation PCSK9 inhibitor built on a recombinant fusion protein platform. The therapy combines an 11-kDa adnectin engineered to bind PCSK9 with human serum albumin to extend half-life.
This design enables monthly self-administration via small-volume subcutaneous injection, with room-temperature stability up to three months. The simplified regimen positions LEROCHOL as a differentiated alternative to antibody-based PCSK9 inhibitors.
Regulatory Path Ahead
LEROCHOL recently secured FDA approval based on the global LIBerate Clinical Trial Program, which enrolled more than 2,900 patients across cardiovascular risk populations, including HeFH and HoFH. LIB Therapeutics continues to advance LEROCHOL as a long-term lipid-lowering option, supported by durable LDL-C lowering, favorable long-term tolerability, and simplified monthly self-administration.
Reference
About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.