Apolipoprotein B

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).

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.

NewAmsterdam Pharma Announces 2024 Strategic Priorities

Retrieved on: 
Thursday, January 4, 2024
Well, ASCVD, Dyslipidemia, Marketing, Apolipoprotein B, Risk, NAMS, Physician, Apolipoprotein, Moyamoya disease, Mortality, Clinical trial, CVD, Phase 3, FDC, Patient, Safety, Cardiovascular disease, Ezetimibe, History, Pharmaceutical industry

-- Well-capitalized with cash to support operations through BROADWAY, BROOKLYN, and PREVAIL readouts --

Key Points: 
  • “NewAmsterdam is entering 2024 on the precipice of a major transformation, with the potential to deliver significant benefit to patients globally and create value for our shareholders,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.
  • NewAmsterdam completed enrollment of approximately 350 patients in April 2023 and expects to report topline data in the third quarter of 2024.
  • NewAmsterdam completed enrollment of over 2,500 patients in July 2023 and expects to report topline data in the fourth quarter of 2024.
  • NewAmsterdam expects to complete patient enrollment in PREVAIL in the first quarter of 2024 and to report topline data in 2026.

NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter 2023 Financial Highlights

Retrieved on: 
Monday, November 13, 2023
Apolipoprotein, Risk, AHA, Apolipoprotein B, Cardiovascular disease, History, Patient, American Heart Association, Dyslipidemia, Children of General Hospital, Apolipoprotein E, CETP, ASCVD, Mutation, Moyamoya disease, NAMS, Pharmaceutical industry, Management, MIAMI

NAARDEN, The Netherlands and MIAMI, Nov. 13, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided a corporate update and announced financial highlights for the quarter ended September 30, 2023.

Key Points: 
  • “We experienced strong momentum in the third quarter, continuing the foundational work required to scale NewAmsterdam into a robust clinical and commercial organization,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.
  • “We recently expanded our leadership team with appointments of BJ Jones as Chief Commercial Officer and Ian Somaiya as Chief Financial Officer.
  • In October 2023, NewAmsterdam appointed Ian Somaiya as Chief Financial Officer.
  • Live webcasts of both fireside chats will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com .

Arrowhead Presents New Phase 2 Data on Plozasiran and Zodasiran at AHA 2023

Retrieved on: 
Monday, November 13, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, MTV: TRL Christmas, Malignancy, Safety, Fasting, Heart, Risk, AHA, Hypertriglyceridemia, TGS, Apolipoprotein B, Serum, Cleveland Clinic, Baylor College of Medicine, APOC3, American Heart Association, Dyslipidemia, MD, Triglyceride, Doctor of Philosophy, ASCVD, Arrowhead Pharmaceuticals, ANGPTL3, Moyamoya disease, Pharmaceutical industry, Shipbuilding, Medical device, Arrowhead, Medicine, Patient

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented new Phase 2 clinical data from the ongoing SHASTA-2 and MUIR studies of plozasiran (ARO-APOC3) and the ARCHES-2 study of zodasiran (ARO-ANG3) at the American Heart Association (AHA) Scientific Sessions 2023, being held in Philadelphia, PA, on November 11-13, 2023.

Key Points: 
  • Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented new Phase 2 clinical data from the ongoing SHASTA-2 and MUIR studies of plozasiran (ARO-APOC3) and the ARCHES-2 study of zodasiran (ARO-ANG3) at the American Heart Association (AHA) Scientific Sessions 2023, being held in Philadelphia, PA, on November 11-13, 2023.
  • Despite potent LDL-C lowering therapies, residual ASCVD risk persists due in part to high levels of atherogenic TRLs.
  • At 24 weeks, plozasiran durably decreased serum APOC3 to -79%, TGs to -74%, and remnant cholesterol to -63%, while increasing HDL-cholesterol to +68%.
  • Serious TEAEs were not related to plozasiran and were resolved without sequelae, except two subjects with malignancies.

OrsoBio to Present Phase 1 Data for the Liver-Targeted LXR Inverse Agonist TLC-2716 in Development for Severe Hypertriglyceridemia and NASH at AHA’s Scientific Sessions 2023

Retrieved on: 
Monday, November 6, 2023
Biotechnology, Diabetes, Health, Pharmaceutical, Clinical Trials, C3, Plasma, De novo, LXR, DSM-IV codes, Liver, MD, Safety, Apolipoprotein B, American Heart, Lipid, Oral, NASH, LDL, PK, Liver X receptor, Triglyceride, Liver disease, AE, Patient, Fatty liver disease, Cholesterol, Hypertriglyceridemia, Pharmaceutical industry, Pharmacokinetics, ANGPTL3

TLC-2716 is in clinical development as a potential treatment for severe hypertriglyceridemia (SHTG) and nonalcoholic steatohepatitis (NASH).

Key Points: 
  • TLC-2716 is in clinical development as a potential treatment for severe hypertriglyceridemia (SHTG) and nonalcoholic steatohepatitis (NASH).
  • In data presented at AASLD’s The Liver Meeting®, TLC-2716 demonstrated highly potent and consistent improvements in plasma triglycerides and cholesterol and hepatic steatosis in preclinical models.
  • Notably, due to active hepatic uptake and limited systemic exposures, TLC-2716 did not adversely affect peripheral reverse cholesterol transport.
  • The results support the ongoing development of TLC-2716 in patients with metabolic disorders including SHTG and NASH.

Silence Therapeutics Announces Positive Topline Results from Phase 1 Multiple Dose Study of Zerlasiran in Subjects with High Lipoprotein(a) and Stable Atherosclerotic Cardiovascular Disease

Retrieved on: 
Wednesday, November 1, 2023
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, RNA, Moyamoya disease, Data, Apolipoprotein B, LDL, Therapy, Patient, Small RNA, APOLLO, ASCVD, Cardiovascular disease, Pharmaceutical industry

Zerlasiran is a siRNA (short interfering RNA) designed to lower the body’s production of Lp(a), a key genetic risk factor for cardiovascular disease affecting approximately 20% of the world’s population.

Key Points: 
  • Zerlasiran is a siRNA (short interfering RNA) designed to lower the body’s production of Lp(a), a key genetic risk factor for cardiovascular disease affecting approximately 20% of the world’s population.
  • In the double-blind placebo-controlled treatment period, zerlasiran (200 mg, 300 mg and 450 mg) was administered twice subcutaneously at two different dosing intervals to ASCVD patients.
  • These data demonstrated a significant reduction from baseline in Lp(a) of up to 99% at 90 days following injection of repeated doses.
  • Silence expects to report topline 36-week data in the first quarter of 2024 and topline 48-week data in the second quarter of 2024.

Variants in the genome interact with each other and with the environment to affect risk of cardiovascular disease

Retrieved on: 
Thursday, September 14, 2023
AMGN, Genetic distance, Genetics, Cholesterol, Cardiovascular disease, Drinking, University of Copenhagen, Metabolism, Risk, LDL, Cell, Paper, Coronary artery disease, Health, Apolipoprotein B, Icelandic, APOE2, Environment, Alzheimer's disease, Copenhagen University Library, Genome, Disease, Complex, Pharmaceutical industry, Vaccine, Amgen

The work described in the paper is based on searching for variants in the genome that associate with variance in quantitative traits and the assumption that those variants must interact either with other variants or components of the environment.

Key Points: 
  • The work described in the paper is based on searching for variants in the genome that associate with variance in quantitative traits and the assumption that those variants must interact either with other variants or components of the environment.
  • It is well established that the "bad" cholesterol (also called non-HDL cholesterol and LDL cholesterol) directly contributes to the development of cardiovascular disease.
  • The environment and the genome both influence bad cholesterol and consequently cardiovascular health.
  • Similarly, the authors show that variants in the genome interact with each other to affect cholesterol levels.

Variants in the genome interact with each other and with the environment to affect risk of cardiovascular disease

Retrieved on: 
Thursday, September 14, 2023
AMGN, Genetic distance, Genetics, Cholesterol, Cardiovascular disease, Drinking, University of Copenhagen, Metabolism, Risk, LDL, Cell, Paper, Coronary artery disease, Health, Apolipoprotein B, Icelandic, APOE2, Environment, Alzheimer's disease, Copenhagen University Library, Genome, Disease, Complex, Pharmaceutical industry, Vaccine, Amgen

The work described in the paper is based on searching for variants in the genome that associate with variance in quantitative traits and the assumption that those variants must interact either with other variants or components of the environment.

Key Points: 
  • The work described in the paper is based on searching for variants in the genome that associate with variance in quantitative traits and the assumption that those variants must interact either with other variants or components of the environment.
  • It is well established that the "bad" cholesterol (also called non-HDL cholesterol and LDL cholesterol) directly contributes to the development of cardiovascular disease.
  • The environment and the genome both influence bad cholesterol and consequently cardiovascular health.
  • Similarly, the authors show that variants in the genome interact with each other to affect cholesterol levels.

Significant First Responder Biomarker Improvements Drive InsideTracker to Launch Custom Blood Test Panel

Retrieved on: 
Wednesday, August 30, 2023
Triglyceride, Firefighter, Glucose, Cardiovascular disease, HDL, Biomarker, Inflammation, National Fallen Firefighters Memorial, Sale, Risk, Nursing, LDL, Blood, Longevity, Apolipoprotein B, Health, Membrane protein, Life, Glycated hemoglobin, Medical device

However, the nature of their demanding and high-stress professions exposes them to elevated health risks with cardiovascular health and stress.

Key Points: 
  • However, the nature of their demanding and high-stress professions exposes them to elevated health risks with cardiovascular health and stress.
  • InsideTracker data verified that first responders are consistently "less healthy" at the time of baseline testing than the general InsideTracker population.
  • Yet, upon retesting with InsideTracker, 65 percent of first responders saw improvements in HDL cholesterol, compared to only 49 percent observed in the general population.
  • InsideTracker is deeply committed to the well-being of the first responder community, which diligently serves their communities every day.