Lerodalcibep

CINCINNATI--( BUSINESS WIRE )--LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, third-generation PCSK9 inhibitor announced positive results from two sub-studies in the LIBerate-OLE (open-label extension) study which were presented as late-breaking oral presentations at Featured Science: Novel Approaches to Managing Lipid Risk Session at American Heart Association 2024 in Chicago, Illinois on November 16. Abstract 4165221: Long-term Efficacy of Lerodalcibep in 1,468 Patients at Very High and High Risk for CVD in the 72-Week Open-Label Extension Trial; Dr. Dean Kereiakes (Lead Investigator) Of 1,655 patients completing the 52-week, placebo-controlled Phase 3 LIBerate-CVD and LIBerate-High Risk trials, 1,468 (90%) patients with, or at very-high risk for, CVD, including 37% female and 20% minorities, continued into the 72-week OLE trial. Mean baseline LDL-C was 109 mg/dL, despite 86% of patients on statins and 18% on ezetimibe. Results: Patients consistently maintained > 60% reductions (P<0.0001) in LDL-C from baseline throughout the additional 72 weeks of OLE dosing, with no signals of attenuation, including in those on Lerodalcibep for > 2 years > 90% of patients achieved ≥ 50% LDL-C reduction from baseline and the new lower LDL-C target of < 55 mg/dL for those with, or at very hisk for, CVD Lerodalcibep reduced mean Apo B by 45% and median Lp(a) by 30-32% Lerodalcibep was well tolerated, with < 1% of doses associated with mild or moderate injection site reactions and < 2% of subjects terminating the trial due to side effects and with no new safety concerns “Monthly Lerodalcibep not only consistently reduced LDL-C by more than 60%, without any evidence of attenuation even after 2+ years, but had similar efficacy among women and minorities and provided robust reductions in Apo B and Lipoprotein (a),” said Dr. Dean Kereiakes, Professor of Medicine at University of Cincinnati and Chairman at The Christ Hospital Heart & Vascular Institute. “Importantly, Lerodalcibep enabled > 90% of these very high risk patients on maximally tolerated statins to achieve the new more stringent guideline LDL-C targets. Lerodalcibep was also well tolerated with only 1.3% of subjects terminating the 72-week trial due to mild or moderate side effects.” Abstract 4170118: Efficacy and Safety of Lerodalcibep, a Third Generation PCSK9 Inhibitor, in 703 Heterozygous Familial Hypercholesterolemia Subjects in the Open-Label Extension Trial; Prof. Derick Raal (Lead Investigator) Of 800 HeFH participants in five base Phase 3 LIBerate trials, 703 (88%) continued into the 72-week OLE trial, including 47% female and 12% minorities. Mean baseline LDL-C was 144.9 mg/dL, despite 91% of patients on statins (71% high intensity) and 52% on ezetimibe. Results: Patients maintained 50% to 53% (P<0.0001), with 72 to 76 mg/dL absolute, reductions in LDL-C throughout the additional 72 weeks with no signals of attenuation Despite high baseline LDL-C, > 80% of patients achieved ≥ 50% LDL-C reduction from baseline and ≥ 70% achieved the new lower recommended LDL-C targets during the study Lerodalcibep reduced mean Apo B by 36% and median Lp(a) by 25% Lerodalcibep was well tolerated, with no new safety concerns “Heterozygous familial hypercholesterolemia effects over 30 million people worldwide. Early and long-term maintenance of effective LDL-C reduction, as shown in over 700 patients in the LIBerate-OLE study, enabled more than 70% to achieve the new lower recommended LDL-C goals of ≥ 50% from baseline and < 55 mg/dL in those with CVD or < 70 mg/dL in those at high risk for CVD,” said Prof. Derick Raal, Distinguished Professor and Director, Carbohydrate & Lipid Metabolism Research Unit at University of Witwatersrand University in South Africa. “In addition, as Lerodalcibep requires only a single, 1.2 mL injection per month, home dosing without the need for refrigeration by patients, good tolerability and safety offers the potential for improved long-term adherence for life-long therapy needed in HeFH.” “The results from both of these studies in over 1,000 patients treated with Lerodalcibep for more than 2 years with no signs of LDL-C attenuation and good tolerability, provide further reassurance of the ability of Lerodalcibep to provide long-term LDL-C control,” said Dr. Evan Stein, Chief Scientific Officer of LIB Therapeutics. “Results also confirmed, in a diverse patient population with CVD and HeFH and a wide range of elevated LDL-C, despite maximally tolerated statin and other oral agents, the longer term efficacy of Lerodalcibep to achieve, and importantly maintain, the new lower guideline directed LDL-C goals.” “We now look forward to submitting a Biologics License Application to the Food and Drug Administration by end of this year, followed by a Marketing Authorization Application to the European Medicines Agency and bringing to patients a more friendly, potential best-in-class, novel PCSK9 inhibitor,” said David Cory, CEO of LIB Therapeutics. About Lerodalcibep Lerodalcibep is a novel, small binding protein, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, single small-volume, subcutaneous injection with long-ambient stability, alternative to monoclonal antibodies. In clinical trials, Lerodalcibep has demonstrated sustained LDL-C reductions and is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH). The global Phase 3 LIBerate program enrolled a diverse population of over 2,700 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once-monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients have continued in the 72-week open-label extension trial. LIB is preparing a biologics license application (BLA) for Lerodalcibep and plans for regulatory submission in 2024, followed by a Marketing Authorization Application to the European Medicines Agency. About LIB Therapeutics Inc. LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing Lerodalcibep to the millions of patients with cardiovascular disease and to the 30 million individuals with familial hypercholesterolemia (FH) around the world, who require additional large reductions in low density lipoprotein-cholesterol (LDL-C), despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals. For more information, please visit: www.libtherapeutics.com .

LIBerate-CVD: 52-Week, Placebo-Controlled Study of Lerodalcibep in Patients with CVD LIBerate-VI: 9-Month Study of Lerodalcibep vs Inclisiran in Very High Risk Patients for CVD CINCINNATI--(BUSINESS WIRE)-- LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, once-monthly, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced positive results from two studies in the recently completed Phase 3 LIBerate registration-enabling program were presented during the 92nd European Atherosclerosis Society Congress in Lyon, France, May 26-29, 2024. Phase 3 LIBerate-CVD Study Late-Breaker Oral Presentation by Evan Stein, MD, PhD, May 29 The global Phase 3 LIBerate-CVD study with 922 patients was a randomized, double-blind, placebo-controlled trial to evaluate Lerodalcibep 52-week efficacy and safety in patients with a history of cardiovascular disease or at very high risk, for CVD on stable lipid-lowering therapy. The co-primary efficacy endpoints were the percent change from baseline in LDL-C at Week 52 and the mean of Weeks 50 and 52. Secondary outcomes included achievement of EAS / ESC LDL-C targets, and other lipid and apolipoproteins changes. Patients were randomized 2:1 to a single 300 mg once-monthly, subcutaneous dose of Lerodalcibep or placebo for 52 weeks. Approximately 85% of participants had CVD, and 30% were female. Mean baseline LDL-C was 102 mg/dL (2.64 mmol/L), despite 85% of patients on statins and 15% on ezetimibe. Results: Co-primary endpoint achieved with Lerodalcibep: significant and persistent LDL-C reductions over 52 weeks of 62% (61 mg/dL, 1.61 mmol/L) at Week 52 and 69.4% (70 mg/dL, 1.81 mmol/L) at mean of Weeks 50 and 52 (P<0.0001) During the study, 94% of all patients achieved the more stringent ESC and now global, lipid targets of ≥50% reduction in LDL-C from baseline and LDL-C <55 mg/dL (1.4 mmol/L) Lerodalcibep robustly reduced non-HDL-C 50.5%, Apo B 45%, Lp(a) 33% Lerodalcipeb was well tolerated. Treatment-emergent adverse events were similar between Lerodalcibep and placebo, with the most common being mild to moderate injection site reactions, and no difference in discontinuations: Lerodalcibep (4.2%) vs placebo (3.6%) Lerodalcibep was not associated with in vivo active ADAs or NAbs. There was no attenuation of either free PCSK9 suppression or LDL-C efficacy “LIBerate-CVD is the final key registration-enabling trial of our global Phase 3 LIBerate program for Lerodalcibep,” said Evan Stein, MD, PhD, Chief Scientific Officer at LIB Therapeutics. “The LIBerate program enrolled a diverse global patient population with CVD, at very high and high risk for CVD, heterozygous and homozygous familial hypercholesterolemia (FH) to support a broad label upon approval. We could not have successfully carried out these global trials without the dedication and enthusiasm of the many investigators and patients around the world.” Phase 3 LIBerate-VI (Lerodalcibep vs Inclisiran) Study Oral Moderated Poster by Professor Ulrich Laufs, MD, May 28 The LIBerate-VI study was a randomized, open-label, study comparing efficacy and safety of Lerodalcibep to inclisiran in patients with, or at very high risk for CVD, on high intensity statin requiring additional LDL-C reduction at Day 270 (9 months). The trial was conducted in 21 centers in France, Germany, Norway, Spain and UK, with patients randomized 1:1 to Lerodalcibep 300 mg monthly or inclisiran 284 mg on Day 1 and 90. Primary efficacy endpoints were the percent LDL-C change from baseline at Day 270. Secondary outcomes included achievement of EAS / ESC LDL-C targets, and other lipid and apolipoprotein changes. Of the 166 patients randomized, 160 completed the trial. Approximately 50% of the patients had CVD, 32% were female and 45% had HeFH. Mean baseline LDL-C was 112 mg/dL (2.85 mmol/L) despite nearly all patients on high intensity statins and ~45% on ezetimibe. Both Lerodalcibep and inclisiran were well tolerated with similar rates of adverse events. At Day 270, mean LDL-C, was decreased from baseline with Lerodalcibep by 53% compared to 45.3% with inclisiran (P=0.0319) in the mITT population, and 55.4% and 45.4%, respectively, in the per-protocol population (P=0.005). More patients achieved the EAS/ESC targets with Lerodalcibep than with inclisiran of >50% reduction in LDL-C from baseline (62% vs 50%) and LDL-C target of <55 mg/dL (1.4 mmol/L) (67% vs 50%). 58% of patients on Lerodalcibep versus 42% on inclisiran met both targets. Greater reductions in non-HDL-C (44.9% vs 38.2%), Apo B (38.2% vs 32.1%) and Lp(a) (26% vs 15.8%) were also seen with Lerodalcibep than with inclisiran (all P<0.05). “These Lerodalcibep data provide additional evidence of a potential best in class pro robust, sustained LDL-C lowering activity in a convenient and patient-friendly, once-monthly, single subcutaneous injection stable at ambient temperature that will not require refrigeration at home or in travel,” said David Cory, CEO of LIB Therapeutics. “We look forward to submitting a Biologics License Application to the Food and Drug Administration later this year, followed by a Marketing Authorization Application to the European Medicines Agency.” About Lerodalcibep Lerodalcibep is a novel, potent, small binding protein, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, single subcutaneous injection with long-ambient stability. In clinical trials, Lerodalcibep has demonstrated sustained LDL-C reductions and is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH). The global Phase 3 LIBerate program enrolled a diverse population of over 2,700 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once-monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients have continued in the 72-week open-label extension trial. LIB is preparing a biologics license application (BLA) for Lerodalcibep and plans for regulatory submission in 2024, followed by a Marketing Authorization Application to the European Medicines Agency. About LIB Therapeutics Inc. LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing Lerodalcibep to the millions of patients with cardiovascular disease and to the 30 million individuals with familial hypercholesterolemia (FH) around the world, who require additional large reductions in low density lipoprotein-cholesterol (LDL-C), despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals. For more information, please visit: .