Lerodalcibep

CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics Inc. (LIB), a privately-held, biopharmaceutical company with a recently approved novel, monthly, small-dose, third-generation PCSK9 inhibitor, LEROCHOL® (lerodalcibep-liga), today announced results from two oral and two poster presentations at the European Atherosclerosis Society meeting, held in Athens, Greece, May 24-26, 2026. Oral Presentations, May 25, 2026: The Long-Term Efficacy and Safety of Lerodalcibep in Homozygous Familial Hypercholesterolaemia (HoFH) — Dr. David Kallend, MB BS, Chief Medical Officer, LIB Therapeutics, Inc. A total of 43 patients with genetically confirmed HoFH completed the 72-week, open-label, extension study, with mean and absolute LDL-C reductions of 19.1% and 1.44 mmol/L (55.7 mg/dL), respectively, at the 72-week primary endpoint. At week 72, mean ApoB was reduced by 12.7% and median Lp(a) by 20.6%. Lerodalcibep was well-tolerated, with the only related adverse events being sporadic and mild injection site adverse events. Efficacy and Safety of Lerodalcibep, a Novel, Third Generation PCSK9 Inhibitor, in Subjects With Severe LDL-C Elevations Completing the 124-Week Open-Label Phase 3 Extension Study — Dr. David Kallend, MB BS (Late Breaker Abstracts in PCSK9 Pharmacology) A total of 151 participants in phase 3 trials with heterozygous familial hypercholesterolemia (HeFH), HoFH, or markedly elevated LDL-C, completing a base trial, entered a 124-week open-label extension trial and received monthly lerodalcibep 300 mg subcutaneously, dosed in a clinic or at home. The mean age (range) was 51.4 (14-83) years, with 90.1% on statins and 54.3% on ezetimibe, and the mean baseline LDL-C was 4.47 mmol/L (172.9 mg/dL). The mean reduction in LDL-C from original baseline was 52%, with mean absolute reductions in LDL-C of 2.3 mmol/L (88.9 mg/dL), ApoB of 38.9%, and Lp(a) of 28.7% through Week 124, similar to those observed in the base trials. Lerodalcibep was well-tolerated, with no treatment-related serious adverse events or other safety findings. Injection site adverse events were mild, moderate, and transient, and no participants withdrew from the study. "The 72- and 124-week open-label extension studies, which over 90% of participants completed, provide further information on lerodalcibep’s longer term robust and sustained reductions in LDL-C and other lipids and lipoproteins, safety and tolerability, and, importantly, patient adherence,” commented Dr. Kallend. Poster Sessions: Lack of Sex Differences in LDL-Cholesterol Response to PCSK9 Inhibitors: Analysis From the Lerodalcibep Pooled Placebo Controlled Phase 3 Trials of 2,322 Subjects - With, Or at Very High or High Risk for Atherosclerotic Cardiovascular Disease (ASCVD) — Traci Turner, MD, MRL Metabolic and Atherosclerosis Research Center, USA This post-hoc analysis assessed sex differences in LDL-C efficacy with lerodalcibep, a monthly dosed, small recombinant fusion protein PCSK9 inhibitor. Although overall placebo-adjusted LDL-C reductions were moderately greater, at 4.4%, in male patients than in female patients (−60.4% vs −56%, respectively), absolute LDL-C reductions in female patients were greater. When LDL-C was stratified by cut-points of 50% reduction and target LDL-C levels in the EAS/ESC guidelines in >90% of participants during the trial. The reduction in mean apoB was 44.1% and in median Lp(a) was 27.6%. New onset diabetes was 3.3% in PBO and 3.1% in LERO. Of 31 total adjudicated CV events (5-point MACE), 4.7% occurred in PBO and 3.3% in LERO; HR 0.717 (95% CI: 0.352,1.464) "These four presentations of long-term trials, exceeding 2.5 years of treatment with lerodalcibep, provide further information on the robust and sustained reductions in LDL-C, combined with excellent patient adherence and tolerability, with this monthly, self-dosed, novel alternative PCSK9 inhibitor to the monoclonal antibody platform. The post hoc analysis assists us in clarifying previously reported sex differences in female subjects in studies of other PCSK9 inhibitors. It provides additional data on lerodalcibep, including LDL-C efficacy and impact on glycemic indicators. The convenient, monthly, single, small, self-dosed, subcutaneous regimen and 3-month room temperature stability address a significant unmet patient need in lipid management for long-term therapy," commented Dr. Stein. IMPORTANT SAFETY INFORMATION Adverse Reactions The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults (including heterozygous familial hypercholesterolemia [HeFH]) ≥2% of patients treated with LEROCHOL ® (lerodalcibep-liga) and occurring more frequently than with placebo) were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo) and peripheral edema (2% and <1% versus placebo). The most commonly occurring adverse reactions in clinical trials in HeFH (≥2% of patients treated with LEROCHOL and occurring more frequently than with placebo) were injection site reactions (18% and 3% versus placebo), nasopharyngitis (13% and 9% versus placebo), diarrhea (3% and 1% versus placebo), nausea (2% and 0% versus placebo) and peripheral edema (2% and <1% versus placebo). The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% vs. 0%). Immunogenicity LEROCHOL is a recombinant fusion protein. As with all therapeutic proteins, there is potential for immunogenicity with LEROCHOL. INDICATIONS LEROCHOL® (lerodalcibep-liga) is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). For full prescribing information, please visit About LEROCHOL® (lerodalcibep-liga) LEROCHOL is a novel, small protein-binding, third-generation PCSK9 inhibitor. It has been developed as a convenient, once-monthly, self-administered, single, small-volume, subcutaneous injection, with extended room-temperature stability up to 3 months. These features make LEROCHOL a unique alternative to other PCSK9 inhibitors. The anti-PCSK9 binding domain of LEROCHOL is an 11-kDa polypeptide called an adnectin, engineered for high-affinity subnanomolar binding to human PCSK9, and fused to human serum albumin to enhance plasma half-life. About the LIBerate Clinical Trial Program™ The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2900 patients with cardiovascular disease (CVD), without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. LEROCHOL was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2400 patients continued in the 72-week open-label extension trial. In clinical trials, LEROCHOL demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very high or high risk of, cardiovascular disease and ≥59% in those with HeFH who have more severe LDL-C elevations. LEROCHOL was generally well-tolerated across the LIBerate Clinical Trial Program, with no serious treatment-related adverse events reported in the long-term extension studies. About LIB Therapeutics, Inc. LIB Therapeutics is a privately held, commercial-stage biopharmaceutical company dedicated to bringing novel, highly effective, and safe therapies to help the millions of patients with cardiovascular disease and familial hypercholesterolemia finally achieve their LDL-C goals. The company has also submitted a Marketing Authorization Application to the European Medicines Agency, with anticipated approval in 2H 2026. In Greater China, the Biologics License Application is expected to be submitted in 1H 2026, with potential approval in 2027. LIB is pursuing additional regulatory submissions in other markets worldwide. For more information, please visit: Contacts For media inquiries: Carly Scaduto Carly@carlyscadutoconsulting.com For non-media inquiries: Info@libtherapeutics.com