LIB Therapeutics Highlights New Clinical Findings on LEROCHOL Presented at the 2026 European Atherosclerosis Society Congress in Athens
LIB Therapeutics has reported new long-term clinical data for LEROCHOL® (lerodalcibep-liga), its recently approved third-generation PCSK9 inhibitor, during presentations at the European Atherosclerosis Society Meeting 2026 held in Athens, Greece from May 24-26, 2026. The company presented findings from two oral sessions and two poster presentations highlighting the efficacy, safety, tolerability, and long-term adherence associated with lerodalcibep across multiple patient populations with severe lipid disorders and elevated cardiovascular risk.
The data presented at the meeting focused on long-term treatment outcomes extending beyond two years in patients with homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH), severe LDL cholesterol elevations, and diabetes-associated cardiovascular risk. The studies collectively reinforced the potential of lerodalcibep as a durable, monthly, self-administered alternative to monoclonal antibody PCSK9 inhibitors.
Lerodalcibep, marketed as LEROCHOL®, is designed as a small recombinant fusion protein that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein involved in regulating LDL receptor degradation. By inhibiting PCSK9 activity, therapies such as lerodalcibep increase the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C) from the bloodstream.
Elevated LDL-C remains one of the major risk factors for atherosclerotic cardiovascular disease, including heart attack and stroke. Patients with inherited lipid disorders such as familial hypercholesterolemia often experience extremely high cholesterol levels despite standard lipid-lowering therapies, making additional treatment options particularly important.
One of the key oral presentations examined the long-term efficacy and safety of lerodalcibep in patients with genetically confirmed Homozygous Familial Hypercholesterolemia. The study results were presented by Dr. David Kallend, Chief Medical Officer of LIB Therapeutics.
A total of 43 patients completed the 72-week open-label extension study. Researchers observed a mean LDL-C reduction of 19.1% at the primary endpoint after 72 weeks of treatment. In absolute terms, LDL-C levels decreased by 1.44 mmol/L, equivalent to approximately 55.7 mg/dL.
In addition to LDL cholesterol reductions, the study demonstrated improvements in other lipid and lipoprotein markers associated with cardiovascular risk. Mean apolipoprotein B (ApoB) levels declined by 12.7%, while median lipoprotein(a), or Lp(a), levels were reduced by 20.6% at week 72.
The therapy was generally well tolerated throughout the study period. According to investigators, the only treatment-related adverse events involved occasional mild injection site reactions. No significant safety concerns emerged during the extension study.
HoFH is one of the most severe inherited lipid disorders and is characterized by extremely elevated cholesterol levels beginning early in life. Patients with HoFH frequently require aggressive lipid-lowering therapies because conventional statins and other treatments often provide insufficient LDL-C reduction. Long-term therapeutic durability is particularly important in this patient population because cardiovascular complications can develop at an early age.
A second oral presentation focused on efficacy and safety data from a 124-week open-label Phase 3 extension study involving patients with severe LDL-C elevations, including individuals with HeFH, HoFH, or markedly elevated cholesterol levels. This presentation was featured in the conference’s late-breaker PCSK9 pharmacology session.
The extension trial enrolled 151 participants who had completed earlier Phase 3 base studies and continued treatment with monthly subcutaneous lerodalcibep 300 mg either in clinic settings or through home administration.
Participants had a mean age of 51.4 years, with ages ranging from 14 to 83 years. Most patients remained on background lipid-lowering therapies during the study, including statins in approximately 90% of participants and ezetimibe in more than half of the cohort.
The mean baseline LDL-C level entering the studies was 4.47 mmol/L, or roughly 172.9 mg/dL, reflecting a population with persistently elevated cholesterol despite standard treatment approaches.
Across the 124-week treatment period, investigators observed a sustained mean LDL-C reduction of 52% from original baseline values. Absolute LDL-C reductions averaged 2.3 mmol/L, equivalent to approximately 88.9 mg/dL.
Researchers also reported substantial improvements in additional cardiovascular biomarkers. ApoB levels declined by 38.9%, while median Lp(a) levels decreased by 28.7%. These effects remained consistent with reductions previously observed during the earlier base studies, suggesting durable long-term efficacy.
Safety findings from the two-year extension study were also favorable. Investigators reported no treatment-related serious adverse events and no major new safety signals. Injection site reactions, when observed, were generally mild or moderate in severity and transient in duration. Importantly, no participants withdrew from the study because of injection site adverse events.
Dr. Kallend noted that the long-term extension studies, both of which achieved participant completion rates exceeding 90%, provide additional insight into the sustained lipid-lowering efficacy, safety profile, and patient adherence associated with lerodalcibep therapy.
The company also presented two poster sessions exploring additional clinical questions related to sex-based responses and diabetic populations.
One poster presentation, delivered by Dr. Traci Turner of the MRL Metabolic and Atherosclerosis Research Center, analyzed potential sex differences in LDL-C responses to PCSK9 inhibition using pooled placebo-controlled Phase 3 trial data from 2,322 subjects with established or high-risk Atherosclerotic Cardiovascular Disease.
The post-hoc analysis examined LDL-C reduction patterns between male and female participants treated with lerodalcibep. Overall placebo-adjusted percentage LDL-C reductions appeared modestly greater in male patients compared with female patients, at 60.4% versus 56%, respectively.
However, investigators found that absolute LDL-C reductions were actually greater among female participants. Further analysis stratified by baseline LDL-C levels demonstrated that the apparent sex differences were largely attributable to differences in entry criteria and baseline cholesterol values rather than reduced efficacy in women.
The analysis suggested that previously reported sex-related differences observed with some PCSK9 inhibitors may be misleading because male patients often enter studies with lower qualifying LDL-C thresholds. When baseline LDL-C was appropriately stratified, female patients demonstrated minimal or slightly greater placebo-adjusted percentage responses.
A second poster presentation focused on diabetic patients enrolled in pooled analyses from the 52-week placebo-controlled Phase 3 LIBerate-CVD and LIBERATE-HR studies. The presentation was delivered by Dr. Evan A. Stein, Chief Executive Officer and Chief Scientific Officer of LIB Therapeutics.
The analysis included 819 diabetic patients receiving maximally tolerated statin therapy who were randomized in a 2:1 ratio to receive lerodalcibep or placebo.
At week 52, placebo-adjusted LDL-C reductions averaged approximately 60%, while reductions measured at the mean of weeks 50 and 52 reached 68%. More than 90% of patients receiving lerodalcibep achieved both LDL-C reductions exceeding 50% and guideline-recommended target cholesterol levels established by the European Atherosclerosis Society and European Society of Cardiology.
The treatment also produced favorable changes in additional lipid parameters. Mean ApoB levels decreased by 44.1%, while median Lp(a) declined by 27.6%.
Investigators additionally evaluated glycemic outcomes and cardiovascular events during the study period. Rates of new-onset diabetes were similar between placebo and treatment groups, occurring in 3.3% of placebo-treated patients and 3.1% of lerodalcibep-treated participants.
Among the 31 adjudicated five-point major adverse cardiovascular events (MACE) reported during the analysis, 4.7% occurred in placebo-treated patients compared with 3.3% in the lerodalcibep group. The hazard ratio was reported as 0.717, though the confidence interval indicated the study was not powered to definitively establish cardiovascular outcomes benefit.
Dr. Stein commented that the four presentations collectively provide further evidence supporting the long-term efficacy, sustained LDL-C reduction, excellent adherence, and favorable tolerability profile of lerodalcibep over treatment durations exceeding 2.5 years.
He emphasized that the therapy’s monthly, small-volume, self-administered subcutaneous dosing regimen may address important unmet needs in long-term lipid management. Unlike some injectable lipid therapies requiring refrigeration or more frequent administration, lerodalcibep offers three-month room temperature stability, potentially improving convenience and adherence for patients managing chronic cardiovascular risk.
The company believes these characteristics may differentiate lerodalcibep within the expanding PCSK9 inhibitor market, particularly for patients requiring durable and convenient LDL-C lowering beyond what statins and oral therapies alone can achieve.
LIB Therapeutics also reiterated important safety information regarding LEROCHOL®. In clinical trials involving adults with primary hyperlipidemia, including HeFH, the most common adverse reactions occurring in at least 2% of patients included nasopharyngitis, injection site reactions, and peripheral edema.
Among HeFH patients specifically, commonly reported adverse events included injection site reactions, nasopharyngitis, diarrhea, nausea, and peripheral edema. Injection site reactions represented the most frequent adverse event leading to treatment discontinuation, though discontinuation rates remained low overall.
As a recombinant fusion protein therapy, lerodalcibep also carries the potential risk of immunogenicity, consistent with other therapeutic protein products.
LEROCHOL® is currently indicated as an adjunct to diet and exercise for reducing LDL cholesterol in adults with hypercholesterolemia, including patients with heterozygous familial hypercholesterolemia.
The extensive long-term data presented at the European Atherosclerosis Society meeting reinforce LIB Therapeutics’ broader strategy of positioning lerodalcibep as a differentiated next-generation PCSK9 inhibitor capable of delivering sustained lipid lowering, simplified administration, and strong patient adherence across diverse cardiovascular risk populations.
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.
