Apolipoprotein

LIB Therapeutics Announces Positive Results from LIBerate-HR Study: A 52-Week, Placebo-Controlled Registration-Enabling Trial of Lerodalcibep at Late-Breaking Session at American College of Cardiology 2024

Retrieved on: 
Monday, April 8, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Week, Temperature, Cardiovascular disease, PCSK9, CVD, ADAS, FH, Patient, Travel, Female, Refrigeration, OLE, MBBS, Marketing, European Medicines Agency, American College, Therapy, Liberation, ITT, Safety, Food, ACC, Apolipoprotein B, Apolipoprotein, Pharmaceutical industry

Patients were randomized 2:1 to a single 300 mg (1.2 mL subcutaneous) once-monthly dose of Lerodalcibep or placebo for 52 weeks.

Key Points: 
  • Patients were randomized 2:1 to a single 300 mg (1.2 mL subcutaneous) once-monthly dose of Lerodalcibep or placebo for 52 weeks.
  • Of 478 participants in the base LIBerate-HeFH trial, 421 (88%) continued into the OLE trial: 281 patients on Lerodalcibep and 140 on placebo.
  • All participants received open-label Lerodalcibep 300 mg in a subcutaneous 1.2 mL once-monthly dose starting immediately upon completion of the base trial.
  • After 48 weeks of OLE treatment, mean % LDL-C reductions with Lerodalcibep from baseline in the base trial was 48.5% (ITT population).

American College of Cardiology Presentation Highlights Promising Results Showing Potential to Reduce Coronary Inflammation with Abcentra's Orticumab

Retrieved on: 
Monday, April 8, 2024
Cardiovascular disease, Chest pain, Psoriasis, Coronary artery disease, Risk, Inflammation, Patient, Cardiovascular Research, Death, Plaque, Artery, American College, CCTA, Apolipoprotein, Heart, ACC, FAI, Pharmaceutical industry

ATLANTA, April 8, 2024 /PRNewswire/ -- Abcentra LLC, a clinical-stage biopharmaceutical company specializing in coronary artery disease, presented the latest results from a Phase 2a pilot, placebo-controlled, randomized clinical trial of Orticumab, a new drug with a novel mechanism of action to combat coronary inflammation, at the American College of Cardiology (ACC) Annual Scientific Sessions in Atlanta. The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.

Key Points: 
  • The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.
  • Orticumab is a monoclonal antibody against oxidized low-density lipoprotein (oxLDL), a key driver of plaque inflammation and destabilization in coronary artery disease.
  • Abcentra partnered with Caristo Diagnostics to leverage its CaRi-Heart AI technology to measure changes in patients' coronary artery inflammation as result of therapeutic intervention.
  • The results from this trial indicate that targeting oxLDL with Orticumab may reduce residual inflammatory risk and improve outcomes for patients with cardiovascular disease.

American College of Cardiology Presentation Highlights Promising Results Showing Potential to Reduce Coronary Inflammation with Abcentra's Orticumab

Retrieved on: 
Monday, April 8, 2024
Cardiovascular disease, Chest pain, Psoriasis, Coronary artery disease, Risk, Inflammation, Patient, Cardiovascular Research, Death, Plaque, Artery, American College, CCTA, Apolipoprotein, Heart, ACC, FAI, Pharmaceutical industry

ATLANTA, April 8, 2024 /PRNewswire/ -- Abcentra LLC, a clinical-stage biopharmaceutical company specializing in coronary artery disease, presented the latest results from a Phase 2a pilot, placebo-controlled, randomized clinical trial of Orticumab, a new drug with a novel mechanism of action to combat coronary inflammation, at the American College of Cardiology (ACC) Annual Scientific Sessions in Atlanta. The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.

Key Points: 
  • The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.
  • Orticumab is a monoclonal antibody against oxidized low-density lipoprotein (oxLDL), a key driver of plaque inflammation and destabilization in coronary artery disease.
  • Abcentra partnered with Caristo Diagnostics to leverage its CaRi-Heart AI technology to measure changes in patients' coronary artery inflammation as result of therapeutic intervention.
  • The results from this trial indicate that targeting oxLDL with Orticumab may reduce residual inflammatory risk and improve outcomes for patients with cardiovascular disease.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Clene Announces Peer-Reviewed Publication Characterizing the Protein Corona of the Investigational Neurodegenerative Disease Drug, CNM-Au8®

Retrieved on: 
Friday, March 15, 2024
Pharmacology, Toxicity, Protein corona, Brain, Plasma, Longevity, Multiple sclerosis, BBB, ALS, CNM, University college, Medicine, Gastrointestinal tract, Research, Gold, Blood, Traffic barrier, Radiology, Protein, Clinical trial, CSO, Neurodegenerative disease, Apolipoprotein, Research fellow, Copper

Simultaneously, the depletion of opsonin-based proteins in the corona extends their circulation time in the blood, as observed clinically.

Key Points: 
  • Simultaneously, the depletion of opsonin-based proteins in the corona extends their circulation time in the blood, as observed clinically.
  • “When we invented the electro-crystal-chemical method to grow clean-surfaced, highly faceted gold nanocrystals, we certainly had catalytic optimization in mind.
  • However, we also understood that the protein corona can control the location of our nanocrystals in vivo.
  • A Phase 3 registrational clinical trial of CNM-Au8 for the treatment of the progressive neurodegenerative disease, amyotrophic lateral sclerosis, is presently planned to launch in 2024.

NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD

Retrieved on: 
Tuesday, March 12, 2024
Consensus, Moyamoya disease, Cardiovascular disease, Myocardial infarction, Dyslipidemia, CVD, Cardiology, Risk, Patient, Apolipoprotein B, Consensus decision-making, Stroke, NAMS, ASCVD, Plaque, Artery, Diet, Cleveland Clinic, Ezetimibe, Clinical trial, Safety, FDC, Apolipoprotein, Genetic disorder, Physician, Pharmaceutical industry

NAARDEN, The Netherlands and MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.

Key Points: 
  • The ACC Expert Consensus set LDL-C goals of below the 70mg/dl for patients with ASCVD and below the 55mg/dl goal for ASCVD patients with very high risk.
  • The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo.
  • NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl.
  • Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.

CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed-dose combination tablet as treatments for hypercholesterolaemia and significantly reducing cardiovascular events

Retrieved on: 
Friday, March 22, 2024
Health, Biometrics, General Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Hypercholesterolemia, European Commission, Bempedoic acid, Risk, Patient, Tablet, Committee, ACL, Ageing, Agent handling, Esperion Therapeutics, EMA, Death, European Medicines Agency, Ezetimibe, Therapy, Moyamoya disease, ATP, FDC, CHMP, Apolipoprotein, Pharmaceutical industry

“The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.

Key Points: 
  • “The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.
  • This first-in-class medicine with proven efficacy in reducing hypercholesterolaemia and preventing cardiovascular risks, is a testament to our tireless efforts to help improve the cardiovascular treatment landscape.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024.

New Research Shows the PrecivityAD2™ Blood Test Has High Accuracy Compared to Amyloid PET Scans in Individuals with Cognitive Impairment

Retrieved on: 
Monday, March 18, 2024
Mental Health, Managed Care, Medical Devices, Hospitals, Neurology, Science, Medical Supplies, Clinical Trials, Biotechnology, Health, Health Technology, Health Insurance, Other Science, Research, Radiology, Pharmaceutical, Seniors, Radiation, APS2, Certification, Brain, Alzheimer's disease, Deficit spending, Disease, Memory, AUC, Patient, Ageing, PET, Journal, Apolipoprotein, City, CLIA, Pathology, Medicare, Amyloid, Medical imaging

The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value.

Key Points: 
  • The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value.
  • The APS2 result was the most robust method among the individual plasma amyloid and tau analytes measured to identify disease.
  • In the published study, the PrecivityAD2 blood test was clinically validated in 583 individuals with cognitive impairment across two independent cohorts.
  • C₂N is working toward obtaining the requisite certification that will permit the PrecivityAD2 test to be available in New York in the near future.

Verve Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
Beam Therapeutics, Research, PCSK9, American Heart Association, Gene editing, Eli Lilly and Company, Blood, FDA, AHA, N-Acetylgalactosamine, Cardiovascular disease, Food, Verve, Safety, RNA, Vertex Pharmaceuticals, Therapy, Genetics, Lilly, Patient, LPA, Medicine, Clinical trial, ANGPTL3, Apolipoprotein, Science, LDLR, G&A, IND, Asialoglycoprotein receptor, Moyamoya disease, Human, Beam, Pharmaceutical industry

BOSTON, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported pipeline updates and financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • BOSTON, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics , a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported pipeline updates and financial results for the fourth quarter and year ended December 31, 2023.
  • “2023 was a momentous year for Verve as we made significant strides towards our mission of protecting the world from cardiovascular disease.
  • Verve expects to initiate the VERVE-201 Phase 1b clinical trial in the second half of 2024, subject to regulatory clearances.
  • In October 2023 , Verve announced the expansion of its relationship with Lilly, which was previously established in June 2023.

WAYLIVRA (volanesorsen): An Antisense Oligonucleotide Inhibitor of Apolipoprotein CIII (apoCIII) mRNA - Market Size, Forecasts, and Emerging Insights, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 27, 2024
Biotechnology, General Health, Pharmaceutical, Health, Head, Metabolism, Apolipoprotein, Ionis Pharmaceuticals, Genetic disorder, Messenger, Connective tissue, SWOT, EU4, Weight, Volanesorsen, Triglyceride, Therapy, FPL, Chylomicron, CIII, Clinical trial, Adipose tissue, Research, Pharmaceutical industry

Further, it also consists of future market assessments inclusive of the WAYLIVRA market forecast analysis for lipodystrophy in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in lipodystrophy.

Key Points: 
  • Further, it also consists of future market assessments inclusive of the WAYLIVRA market forecast analysis for lipodystrophy in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in lipodystrophy.
  • WAYLIVRA (volanesorsen), an antisense oligonucleotide inhibitor of apolipoprotein CIII (apoCIII) mRNA, is being developed by Ionis Pharmaceuticals through its subsidiary company, Akcea Therapeutics to treat familial partial lipodystrophy (FPL).
  • Volanesorsen is an antisense oligonucleotide that binds to apoC-III mRNA, leading to its degradation and preventing the translation of apoC-III protein.
  • What are the other emerging products available and how are these giving competition to WAYLIVRA for lipodystrophy?