Latest news with #Lerodalcibep
Business Wire
06-05-2025
- Business
- Business Wire
LIB Therapeutics Announces Key Results from Presentations at 2025 European Atherosclerosis Society Meeting in Glasgow May 5-6
CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep (LeroChol ®), a novel, monthly, small dose third-generation PCSK9 inhibitor today announced results presented at the May 5-7 2025 European Atherosclerosis Society meeting in Glasgow. LERODALCIBEP ADJUDICATED CARDIOVASCULAR EVENTS IN A PRE-DEFINED POOLED ANALYSIS OF THREE LARGE LONG TERM PHASE III STUDIES – Dr David Kallend May 5th As part of the safety analysis, a prespecified exploratory endpoint of major adverse cardiovasular events (MACE) adjudicated by a blinded Clinical Events Committee of all serious CV adverse events. A patient-level, pre-defined pooled analysis of the pivotal placebo-controlled Phase III studies (LIBerate-HR, LIBerate-CVD and LIBerate-HeFH), included patients on maximally tolerated statin with or without other oral lipid-lowering-therapy. Patients were randomized 2:1 to 300mg lerodalcibep or placebo monthly SC for 24 (LIBerate-HeFH) or 52 weeks (LIBerate-HR and LIBerate-CVD). *placebo adjusted mITT analysis; # MACE = composite of death, resuscitated cardiac arrest, acute myocardial infarction (STEMI and NSTEMI), hospitalization for unstable angina, stroke and coronary revascularization The early and large risk reductions in MACE of 45% to 50% provide encouraging insights into the potential CV benefits of lowering LDL-C with lerodalcibep and these findings await confirmation in a planned large definitive CV outcomes trial to start Q3 this year. PHASE 3 POOLED LONG-TERM SAFETY AND EFFICACY OF LERODALCIBEP IN PATIENTS WITH ASCVD, HEFH, VERY HIGH OR HIGH RISK FOR ASCVD – David Kallend May 6 Pooled safety and efficacy was assessed from the key three blinded placebo-controlled Phase 3 trials (LIBerate-CVD, LIBerate-HR and LIBerate-HeFH) in patients with atherosclerotic cardiovascular disease (ASCVD), very high or high risk for ASCVD on stable maximally tolerated statin therapy and additional oral agents. The mean (SE) placebo-adjusted reductions in LDL-C at (Weeks 24 and 52 respectively) 'trough' with lerodalcibep were; mITT analysis was, 58.6(1.3)% and 59.0(1.5)%, ITT with imputation was 54.9(1.4)% and 52.3(1.7)% Per-Protocol analysis was 61.8(1.4)% and 62.3(1.5)% The placebo adjusted LDL-C reduction at 'peak' (2 week post dose) in the mITT population was 73.7% at Week 50 and the mean of weeks 50 and 52 was 66.0(1.3)%. On lerodalcibep, 83% of subjects at Week 24 and 90% of subjects at Week 52 achieved both ESC/EAS recommended targets of >50 additional LDL-C reduction and their new lower targets. Lerodalcibep was well tolerated with 90.3% and 88.7% of subjects completing the study at Weeks 24 and 52 respectively Adverse events were similar between groups, other than more mild injection site reactions (ISRs) on lerodalcibep. The few and sporadic in-vitro anti-drug antibodies had no impact on efficacy or safety. 'We are very pleased and encouraged by the results from the pooled key registration trials, which were large, of long duration, and placebo-controlled,' said Dr. David Kallend, Chief Medical Officer of LIB Therapeutics. 'The data demonstrates substantial and durable reductions in LDL-C - both in absolute terms and percentage change - as well as in other atherogenic lipoproteins such as Lp(a) and ApoB.' He continued, 'Lerodalcibep was well tolerated with no safety concerns or drug-drug interactions, especially important for patients with CVD already on multiple other oral therapeutic agents. Its patient-friendly profile, including the only monthly, 12 doses per year, single small-volume SC injection which along with long-term ambient stability not requiring refrigeration by patients, makes it especially well-suited for patients with CVD or at high-risk for CVD, including those with FH, to help them achieve the new, more aggressive LDL-C targets and maintain life long adherence to therapy.' 'While the number of CV events in the pooled phase trials was limited, the early, large, and statistically significant reductions in MACE are highly encouraging. We look forward to initiating a differentiated cardiovascular outcomes trial to further explore and confirm these findings.' About Lerodalcibep Lerodalcibep is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, single small-volume, subcutaneous injection that will not require refrigeration at home or in travel. These features make Lerodalcibep a unique alternative to approved PCSK9 inhibitors. The anti-PCSK9 binding domain of Lerodalcibep 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. In clinical trials, Lerodalcibep has demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very-high or high risk of, cardiovascular disease (CVD) and ≥50% in those with heterozygous familial hypercholesterolemia (FH) who have more severe LDL-C elevations, and is expected to expand treatment options for the millions of patients around the world with CVD, including the 30 million individuals with FH. The global Phase 3 LIBerate program enrolled a diverse population of over 2,900 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. Following the FDA BLA submission, LIB is preparing a Marketing Authorization Application to the European Medicines Agency. LIB submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in December 2024, and received formal filing by FDA in February with and anticipated PDUFA date in mid Dec this year. LIB is seeking approval of lerodalcibep to reduce LDL-C for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous and homozygous familial hypercholesterolemia (HeFH / HoFH). 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 LDL-C, despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals.
Yahoo
17-02-2025
- Business
- Yahoo
PCSK9 Inhibitors Market Anticipate to Accelerate in the Coming 10 Years Owing to the Increasing Demand for Innovative Cholesterol-Lowering Drugs
The PCSK9 inhibitor market is projected to experience substantial growth due to its use in statin-intolerant patients, emerging strategies for PCSK9 inhibition, its potential applications across broader therapeutic areas, and its role in prophylactic treatment, which could help alleviate the burden of cardiovascular disease. New York, USA, Feb. 17, 2025 (GLOBE NEWSWIRE) -- PCSK9 Inhibitors Market Anticipate to Accelerate in the Coming 10 Years Owing to the Increasing Demand for Innovative Cholesterol-Lowering Drugs | DelveInsight The PCSK9 inhibitor market is projected to experience substantial growth due to its use in statin-intolerant patients, emerging strategies for PCSK9 inhibition, its potential applications across broader therapeutic areas, and its role in prophylactic treatment, which could help alleviate the burden of cardiovascular disease. DelveInsight's PCSK9 Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging PCSK9 inhibitors, market share of individual therapies, and current and forecasted PCSK9 inhibitor market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the PCSK9 Inhibitor Market Report As per DelveInsight's analysis, the PCSK9 inhibitor market size was USD 2 billion in the 7MM in 2023. Across the 7MM, an estimated 640K diagnosed cases of familial hypercholesterolemia were reported in 2023 out of which homozygous cases were very rare. In 2023, peripheral artery disease accounted for the highest number in the total risk factor-specific cases of PCSK9 Inhibitors in prophylactic/preventive settings in the 7MM. Leading PCSK9 inhibitor companies such as LIB Therapeutics, Merck, Verve Therapeutics, CiVi Biopharma, and others are developing novel PCSK9 inhibitors that can be available in the PCSK9 inhibitor market in the coming years. Some of the key PCSK9 inhibitors in the pipeline include Lerodalcibep, MK-0616, VERVE-101, VERVE-102, CiVi 008, and others. In May 2024, LIB Therapeutics announced positive results from two studies in the recently completed Phase III LIBerate registration-enabling program during the 92nd European Atherosclerosis Society Congress in Lyon, France, May 26-29, 2024. In May 2024, AstraZeneca announced Phase I trial data for its PCSK9 inhibitor, AZD0780, which showed a statistically significant reduction of low-density lipoprotein cholesterol in patients with hypercholesterolemia. Discover which therapies are expected to grab the PCSK9 inhibitor market share @ PCSK9 Inhibitor Market and Competitive Landscape Report PCSK9 Inhibitor Market Dynamics The PCSK9 inhibitor market is evolving rapidly, driven by the increasing prevalence of cardiovascular diseases, growing demand for cholesterol-lowering therapies, and advancements in biologics. PCSK9 inhibitors, such as alirocumab (PRALUENT) and evolocumab (REPATHA), have demonstrated strong efficacy in reducing LDL cholesterol levels, particularly in patients with familial hypercholesterolemia or those at high cardiovascular risk. Their uptake has been influenced by both clinical benefits and cost-effectiveness concerns, with market players continuously working to enhance accessibility. A major factor shaping market dynamics is pricing and reimbursement. Initially, PCSK9 inhibitors faced slow adoption due to high costs, limiting widespread use despite their clinical advantages. However, manufacturers have since adjusted pricing strategies, offering discounts and rebates to improve insurance coverage. In the U.S., negotiations with payers and the availability of patient assistance programs have gradually improved access, leading to increased prescription rates. In Europe and other markets, pricing negotiations with government healthcare systems play a critical role in uptake. The competitive landscape is also shifting with the entry of new players and alternative treatment approaches. Inclisiran, a small interfering RNA (siRNA)-based therapy developed by Novartis, offers a novel approach by targeting PCSK9 production at the genetic level. Its biannual dosing schedule provides a significant advantage over monoclonal antibody-based PCSK9 inhibitors, potentially reshaping the market. Additionally, ongoing research into oral PCSK9 inhibitors could further expand patient access and disrupt existing treatment paradigms. Despite these advancements, barriers to market expansion remain. Physician awareness, treatment inertia, and competition from established statins and ezetimibe continue to impact adoption. Moreover, the long-term safety and cost-benefit ratio of PCSK9 inhibitors remain areas of scrutiny. As more real-world data emerges and new formulations gain regulatory approval, the market is expected to grow steadily, particularly among high-risk patients who require more aggressive lipid-lowering therapy. Overall, the PCSK9 inhibitor market is transitioning from a niche high-cost therapy to a broader lipid management solution. With continued innovation in drug delivery, pricing adjustments, and expanded indications, the market is poised for sustained growth. Companies that can successfully navigate pricing challenges and demonstrate long-term cardiovascular benefits will likely lead the next phase of market Inhibitor Treatment Market PCSK9 inhibitors have become a significant treatment option for managing hypercholesterolemia, especially in patients at high cardiovascular risk or those who cannot achieve adequate lipid control with conventional therapies like statins. These drugs target PCSK9, a protein involved in cholesterol regulation by promoting the breakdown of low-density lipoprotein (LDL) receptors. By blocking PCSK9, these therapies increase the availability of LDL receptors on liver cells, enhancing the clearance of LDL cholesterol (LDL-C) from the bloodstream. The most widely used monoclonal antibody PCSK9 inhibitors, PRALUENT and REPATHA, are administered via subcutaneous injection every two to four weeks, depending on the regimen. These medications can lower LDL-C levels by up to 60-70%, proving highly effective for patients with familial hypercholesterolemia, established atherosclerotic cardiovascular disease (ASCVD), or statin intolerance. An addition to the PCSK9 inhibitor class is LEQVIO (inclisiran), approved by the FDA in 2021. Unlike monoclonal antibodies, LEQVIO employs small-interfering RNA (siRNA) technology to decrease PCSK9 production in the liver. While PCSK9 inhibitors are highly effective, they are typically reserved for certain patient groups due to their high cost and the availability of cheaper alternatives like statins and ezetimibe. However, recent price decreases and increasing evidence of their safety and effectiveness in lowering cardiovascular risks have led to broader use. In the future, ongoing research could result in more affordable and convenient formulations, potentially increasing the use of PCSK9 inhibitors in managing high cholesterol and reducing cardiovascular risk. Learn more about the FDA-approved PCSK9 inhibitor @ PCSK9 Inhibitor Drugs Key Emerging PCSK9 Inhibitors and Companies Some of the drugs in the pipeline include Lerodalcibep (LIB Therapeutics), MK-0616 (Merck), VERVE 101, VERVE 102 (Verve Therapeutics), CiVi 008 (CiVi Biopharma), and others. Lerodalcibep is a next-generation, third-generation PCSK9 inhibitor designed to address the limitations of existing LDL-C-lowering treatments, such as statins and ezetimibe, and help achieve the lower LDL-C targets set by recent national and international cardiovascular guidelines. It is being developed as a convenient, once-monthly injection with a small volume and long ambient stability. Currently, in Phase III clinical trials, LIB Therapeutics plans to submit a Biologics License Application (BLA) for lerodalcibep by the end of the year, with a potential PDUFA decision expected in the second half of 2025. MK-0616 is an experimental oral PCSK9 inhibitor with the potential to be the first of its kind, aimed at reducing low-density lipoprotein (LDL) cholesterol. It is a macrocyclic peptide that binds to PCSK9, preventing its interaction with LDL receptors. The drug is currently undergoing Phase III clinical trials. Verve Therapeutics is developing two product candidates, VERVE-101 and VERVE-102, both targeting PCSK9. These one-time treatments aim to permanently deactivate the PCSK9 gene in the liver, thereby lowering LDL-C levels that contribute to disease. VERVE-102 is currently being assessed in the Heart-2 Phase Ib clinical trial for patients with HeFH or premature coronary artery disease. Meanwhile, Verve has paused enrollment in the Heart-1 trial for VERVE-101 due to observed laboratory abnormalities. An investigation is underway, and based on the findings, the company plans to collaborate with regulatory authorities to determine the next steps for VERVE-101. After reviewing clinical data from both the Heart-1 and Heart-2 trials, Verve Therapeutics intends to launch a randomized, placebo-controlled Phase II clinical trial for either VERVE-101 or VERVE-102. The anticipated launch of these emerging therapies are poised to transform the PCSK9 inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the PCSK9 inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about PCSK9 inhibitor clinical trials, visit @ PCSK9 Inhibitor Treatment Drugs PCSK9 Inhibitor Overview Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a serine protease that plays a crucial role in cholesterol metabolism by regulating the degradation of low-density lipoprotein (LDL) receptors. This process reduces the clearance of circulating LDL particles, impacting LDL cholesterol (LDL-C) levels. PCSK9 activity is inversely associated with LDL-C levels: gain-of-function mutations in the PCSK9 gene contribute to elevated LDL-C and increased cardiovascular risk in familial hypercholesterolemia, whereas loss-of-function mutations result in lower LDL-C levels and a reduced risk of atherosclerotic cardiovascular disease (ASCVD). PCSK9 inhibitors help regulate cholesterol metabolism by modulating LDL receptor degradation and influencing LDL particle clearance. While hepatocytes are the primary site of PCSK9 production, it is also produced in the intestines and kidneys. By facilitating LDL receptor degradation, PCSK9 reduces receptor availability, limiting its role in lowering blood cholesterol. Three main classes of LDL-C-lowering medications—statins, ezetimibe, and PCSK9 inhibitors—help mitigate cardiovascular risk by increasing LDL receptor density on hepatocyte surfaces, thereby enhancing LDL uptake and clearance. PCSK9 Inhibitors Epidemiology Segmentation In the United States, the total number of prevalent cases of familial hypercholesterolemia were around 1.5 million in 2023 which are expected to grow during the study period, i.e., 2020–2034. In the United States, the mutation-specific cases of familial hypercholesterolemia were approximately 16K PCSK9 in 2023. The PCSK9 inhibitor market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Familial Hypercholesterolemia Total Diagnosed Prevalent Cases of Familial Hypercholesterolemia Type-specific Diagnosed Prevalent Cases of Familial Hypercholesterolemia Age-specific Diagnosed Prevalent Cases of Familial Hypercholesterolemia Mutation-specific Diagnosed Prevalent Cases of Familial Hypercholesterolemia Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive Setting Total Treated Cases of PCSK9 Inhibitors Download the report to understand what epidemiologists are saying about PCSK9 inhibitor patient trends in 7MM @ PCSK9 Inhibitor Patient Pool PCSK9 Inhibitor Report Metrics Details Study Period 2020–2034 PCSK9 Inhibitor Report Coverage 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] PCSK9 Inhibitor Market Size in 2023 USD 2 Billion Key PCSK9 Inhibitor Companies LIB Therapeutics, Merck, Verve Therapeutics, CiVi Biopharma, Sanofi, Regeneron Pharmaceuticals, Amgen, Novartis, Alnylam Pharmaceuticals, and others Key PCSK9 Inhibitor Lerodalcibep, MK-0616, VERVE-102, CiVi 008, PRALUENT (alirocumab), REPATHA (evolocumab/AMG 145), LEQVIO (inclisiran), and others Scope of the PCSK9 Inhibitor Market Report PCSK9 Inhibitor Therapeutic Assessment: PCSK9 Inhibitor current marketed and emerging therapies PCSK9 Inhibitor Market Dynamics: Conjoint Analysis of Emerging PCSK9 Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, PCSK9 Inhibitor Market Access and Reimbursement Discover more about PCSK9 inhibitor drugs in development @ PCSK9 Inhibitor Clinical Trials Table of Contents 1. PCSK9 Inhibitor Market Key Insights 2. PCSK9 Inhibitor Market Report Introduction 3. Executive Summary of PCSK9 Inhibitors 4. Key Events 5. PCSK9 Inhibitor Market Forecast Methodology 6. PCSK9 Inhibitors Market Overview at a Glance in the 7MM 7. PCSK9 Inhibitors: Background and Overview 8. PCSK9 Inhibitors Target Patient Pool 9. PCSK9 Inhibitor Marketed Drugs 10. PCSK9 Inhibitor Emerging Drugs 11. Seven Major PCSK9 Inhibitor Market Analysis 12. PCSK9 Inhibitor Market Access and Reimbursement 13. SWOT Analysis 14. KOL Views 15. Unmet Needs 16. Appendix 17. DelveInsight Capabilities 18. Disclaimer 19. About DelveInsight Related Reports PCSK9 Inhibitors Pipeline PCSK9 Inhibitors Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PCSK9 inhibitors companies, including Ionis Pharmaceuticals, Akeso Biopharma, Amgen, Novo Nordisk, Civi BioPharma, among others. Familial Hypercholesterolemia Market Familial Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key familial hypercholesterolemia companies, including Sanofi, Regeneron Pharmaceuticals, Amgen, Esperion Therapeutics, Aegerion Pharmaceutical, Esperion Therapeutics, Regeneron Pharmaceuticals, Novartis, LIB Therapeutics, NeuroBo Pharmaceuticals, Arrowhead Pharmaceuticals, among others. Homozygous Familial Hypercholesterolemia Market Homozygous Familial Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key homozygous familial hypercholesterolemia companies, including Arrowhead Pharmaceuticals, Novartis, Alnylam Pharmaceuticals, LIB Therapeutics, among others. Hypercholesterolemia Market Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hypercholesterolemia companies, including Novartis Pharmaceuticals, Merck Sharp & Dohme LLC, Esperion Therapeutics, Inc., Arrowhead Pharmaceuticals, LIB Therapeutics LLC, Medpace, Inc., AstraZeneca, NewAmsterdam Pharma, among others. Hypercholesterolemia Pipeline Hypercholesterolemia Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hypercholesterolemia companies, including Novartis Pharmaceuticals, Merck Sharp & Dohme LLC, Esperion Therapeutics, Inc., Arrowhead Pharmaceuticals, LIB Therapeutics LLC, Medpace, Inc., AstraZeneca, NewAmsterdam Pharma, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. 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