Lipid-lowering agent

Tune Therapeutics Unveils Breakthrough Data Showing Stable and Durable Epigenetic Regulation in Non-Human Primates

Retrieved on: 
Monday, May 22, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, DNA, Gene, Lipid-lowering agent, TEMPO, Cardiovascular disease, TM, Cell, RNA, DBD, Gene silencing, CAR, Animal, Patient, Primate, Drug discovery, Mouse, Growth, LNP, Therapy, Phenotype, Society, Disease, Vaccine, Pharmaceutical industry, PCSK9

This data marks a significant waypoint on the path to epigenetic medicine, in that it represents the first demonstration of durable epigenetic gene regulation, in a large animal model, following transient delivery of an epi-editor.

Key Points: 
  • This data marks a significant waypoint on the path to epigenetic medicine, in that it represents the first demonstration of durable epigenetic gene regulation, in a large animal model, following transient delivery of an epi-editor.
  • Tune’s TEMPO platform is based on decades of foundational research by company Co-Founders Charles Gersbach and Fyodor Urnov.
  • “In our journey to develop genetic tuning into a precise and robust therapeutic modality, these results are incredibly promising,” said Derek Jantz, Ph.D., Chief Scientific Officer at Tune Therapeutics.
  • “It’s an exciting time for the field, and we’re thrilled to be leading it.”
    Location: Los Angeles Convention Center Exhibit Hall, Board # 1096
    Both presentations are available on the Tune Therapeutics website, at: https://tunetx.com/tune-therapeutics-unveils-breakthrough-data-showing-s...

Lowers Risk Group Supports International Fraud Awareness Week, Endorses Data as Key Fraud Control

Retrieved on: 
Thursday, November 10, 2022
Best practice, Statistics, Ebook, Nation, ACFE, Education, Environment, Technology, Association, Fraud, Risk, Association of Certified Fraud Examiners, Certified Fraud Examiner, Pressure, Brad Handler, Lipid-lowering agent, Associate, Audit, Pharmaceutical industry

PURCELLVILLE, Va., Nov. 10, 2022 /PRNewswire-PRWeb/ -- Global risk management and consulting firm Lowers Risk Group announced today its participation in International Fraud Awareness Week. As part of its organization-wide support, Lowers Risk Group subsidiary company Lowers & Associates debuted a new eBook that provides handlers of high-value assets with the latest insights on managing fraud during the upcoming holiday season.

Key Points: 
  • PURCELLVILLE, Va., Nov. 10, 2022 /PRNewswire-PRWeb/ -- Global risk management and consulting firm Lowers Risk Group announced today its participation in International Fraud Awareness Week.
  • As part of its organization-wide support, Lowers Risk Group subsidiary company Lowers & Associates debuted a new eBook that provides handlers of high-value assets with the latest insights on managing fraud during the upcoming holiday season.
  • "The current threat environment includes pressure from inflation, supply and distribution challenges, skilled labor shortages, and skyrocketing cybercrime," Lowers Risk Group CEO Mark Lowers, said.
  • For more information on Lowers Risk Group, Lowers & Associates, or to download the free eBook, click here .

Lowers Risk Group Welcomes Sam Ostrander as Senior Director of Business Solutions

Retrieved on: 
Thursday, July 28, 2022
Goal, CEO, Organization, Solution, Lipid-lowering agent, Insurance, Workflow, Ostrander, Fusion Global Business Solutions, Risk management, TPA, Industry, Family, Management

PURCELLVILLE, Va., July 28, 2022 /PRNewswire-PRWeb/ -- Leading enterprise risk management consulting company Lowers Risk Group is pleased to announce the appointment of Sam Ostrander as Senior Director of Business Solutions. In this role, Ostrander will focus on increasing Lowers Risk Group's success in delivering solutions that protect the people, brands, and profits of organizations operating within high-risk, highly regulated environments.

Key Points: 
  • PURCELLVILLE, Va., July 28, 2022 /PRNewswire-PRWeb/ -- Leading enterprise risk management consulting company Lowers Risk Group is pleased to announce the appointment of Sam Ostrander as Senior Director of Business Solutions.
  • In this role, Ostrander will focus on increasing Lowers Risk Group's success in delivering solutions that protect the people, brands, and profits of organizations operating within high-risk, highly regulated environments.
  • With more than 15 years of industry knowledge and relationships, Ostrander will strategically connect clients with business solutions based on their needs.
  • Lowers Risk Group provides comprehensive enterprise risk management solutions to organizations operating in high-risk, highly regulated environments and to organizations that value risk mitigation.

NewAmsterdam Pharma to Present at Upcoming Medical Conferences New Post-Hoc Analyses from Phase 2 ROSE Trial of Obicetrapib in Patients with Dyslipidemia

Retrieved on: 
Thursday, May 19, 2022
Health, Clinical Trials, General Health, Pharmaceutical, Cardiology, Biotechnology, CEST, Cardiovascular disease, Ezetimibe, High, Barter, LDL, TULIP, NLA, Goal, Health, CVD, Clinical trial, Lists of diseases, Imperial College London, Lipid-lowering agent, Coruscant, Research, Vol, Ascendant, Elsevier, EAS, Diet, Congress, Safety, Apolipoprotein, Public health, Standard of care, AHA, CETP, Ford Motor Company, ROSE, Rose trial grounds, Pharmaceutical industry, Communications satellite, Patient

ROSE (NCT04753606) was designed as a placebo-controlled, double-blind, randomized, Phase 2b dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.

Key Points: 
  • ROSE (NCT04753606) was designed as a placebo-controlled, double-blind, randomized, Phase 2b dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
  • A total of 120 patients were randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period.
  • Currently, Obicetrapib is being tested in two Phase 3 trials, BROADWAY and PREVAIL, and a secondary Phase 2 trial, ROSE2.
  • Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial.

NewAmsterdam Pharma Announces ROSE Phase 2 Trial Results Accepted for Featured Science Presentation at 2021 AHA Scientific Sessions

Retrieved on: 
Monday, November 8, 2021
Health, Diabetes, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Janus, Health, ROSE, Safety, Lists of diseases, NAP, AHA, Lipid-lowering agent, Clinical trial, MonashHeart, Goal, Kaiser Permanente, Research, Medpace, Cardiovascular disease, Monash University, Company, CETP, Ezetimibe, Physician, Diabetes, American Heart Association, Ascendant, Pharmaceutical industry, Obicetrapib, NewAmsterdam Pharma, OBICETRAPIB, NEWAMSTERDAM PHARMA

As we previously reported, we are enthusiastic about the results of the ROSE trial and the demonstration of greater than 50% LDL-lowering as an adjunct to high intensity statins.

Key Points: 
  • As we previously reported, we are enthusiastic about the results of the ROSE trial and the demonstration of greater than 50% LDL-lowering as an adjunct to high intensity statins.
  • Based on these results, we anticipate initiation of Phase 3 registration trials by the end of this year.
  • Topline results from the ROSE study, which met its primary endpoint, were released in July of 2021.
  • In April 2020, NewAmsterdam acquired Dezima Pharma from Amgen, including all rights for obicetrapib (formerly AMG 899, now TA-8995) a selective cholesteryl ester transfer protein (CETP) inhibitor.

Valbiotis Announces the Completion of Recruitment for the Phase II HEART Clinical Study Conducted With TOTUM•070 in Hypercholesterolemia, a Risk Factor for Cardiovascular Disease

Retrieved on: 
Monday, September 6, 2021
Research, Fitness & Nutrition, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Lipids, Medical specialties, Branches of biology, Sterols, Cardiology, Lipoproteins, Lipid metabolism disorders, Low-density lipoprotein, Hypercholesterolemia, Cholesterol, Lipid-lowering agent, Phytosterol

In line with its development plan, Valbiotis confirms that the results of the HEART study will be available in the second quarter of 2022.

Key Points: 
  • In line with its development plan, Valbiotis confirms that the results of the HEART study will be available in the second quarter of 2022.
  • The HEART clinical study is a multicenter, international, randomized, placebo-controlled, double-blind study involving 120 people with untreated moderate hypercholesterolemia between 130 and 190 mg/dL.
  • The primary endpoint of the HEART study is the reduction of blood LDL-cholesterol levels, a risk factor for cardiovascular disease and in particular atherosclerosis, and it has several secondary objectives of interest.
  • The medical need is real: according to the WHO, nearly 40% of the world's adult population has high cholesterol, a well-known cardiovascular risk factor.

Simulation Model based on Pooled Phase 3 Data Demonstrating NEXLETOL® (bempedoic acid) Tablet’s Potential to Lower Absolute Cardiovascular Event Risk Presented at ACC.21

Retrieved on: 
Saturday, May 15, 2021
Medical specialties, Circulatory system, Cardiovascular system, Cardiology, Lipoproteins, Bempedoic acid, Statin, Low-density lipoprotein, Cardiovascular disease, Lipid-lowering agent

Using observed changes in LDL-C at week 12, researchers applied the CTT coefficient to calculate an estimated 10-year cardiovascular event relative risk reduction rate.

Key Points: 
  • Using observed changes in LDL-C at week 12, researchers applied the CTT coefficient to calculate an estimated 10-year cardiovascular event relative risk reduction rate.
  • In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering at week 12 when used with moderate or high-intensity statins.
  • The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.\nElevations in serum uric acid have occurred.
  • \xe2\x80\x9cRationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance.\xe2\x80\x9d American Heart Journal.

Indication Bioscience Granted First Patent for Statin Plus Cannabidiol (CBD) Combination

Retrieved on: 
Monday, February 1, 2021
Alternative medicine, Health, General Health, Research, Science, Pharmaceutical, Cardiology, GABAA receptor positive allosteric modulators, Drugs, Statins, Branches of biology, Chemical compounds, Hepatotoxins, Hypercholesterolemia, Niacin, Cholesterol, Discovery and development of statins, Lipid-lowering agent

According to the CDC, approximately 28% of Americans over forty years of age are prescribed a statin for hypercholesterolemia.

Key Points: 
  • According to the CDC, approximately 28% of Americans over forty years of age are prescribed a statin for hypercholesterolemia.
  • In US clinical practices, roughly 45% of patients discontinue statin use after 6 months use due to adverse effects.
  • Findings suggest that cannabinoids such as Cannabidiol in combination with statins decrease the adverse effects of statin drugs while increasing efficacy in treating cardiovascular disease such as hypercholesterolemia.
  • We are extremely pleased to have been granted the first patent for our portfolio of cannabinoid-statin combination therapies.

First-in-class cholesterol-lowering treatment NILEMDO® ▼ (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® ▼ (bempedoic acid and ezetimibe) tablet approved in Switzerland

Retrieved on: 
Wednesday, December 16, 2020
Health, Clinical trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Drugs, Medical specialties, Lipids, Bempedoic acid, ATP citrate lyase, Low-density lipoprotein, Statin, Cholesterol, ATP citrate synthase, Bempedoic acid/ezetimibe, Lipid-lowering agent

Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver.

Key Points: 
  • Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver.
  • This unique mechanism of action allows it to work alongside existing treatments, said Ashley Hall, Chief Development Officer of Esperion.
  • The most commonly reported adverse reactions with bempedoic acid during pivotal trials were hyperuricaemia, pain in extremity and anaemia.
  • Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance.

NEXLETOL® (bempedoic acid) Tablets Highlighted at AHA 2020 with Presentations of Analyses Demonstrating Significant Low-Density Lipoprotein Cholesterol (LDL-C) Lowering vs. Placebo in Phase 3 Study Subgroups

Retrieved on: 
Friday, November 13, 2020
Branches of biology, Medical specialties, Lipids, Cardiology, Lipoproteins, Low-density lipoprotein, Statin, Cholesterol, Bempedoic acid, Lipid-lowering agent, Esperion Therapeutics

Both analyses demonstrated significant lowering of low-density lipoprotein cholesterol (LDL-C) by NEXLETOL (bempedoic acid) Tablets by week 12 in specific subgroups, including people who cannot tolerate statins and females, compared to placebo.

Key Points: 
  • Both analyses demonstrated significant lowering of low-density lipoprotein cholesterol (LDL-C) by NEXLETOL (bempedoic acid) Tablets by week 12 in specific subgroups, including people who cannot tolerate statins and females, compared to placebo.
  • Our goal at Esperion is lipid management for everybody, and these analyses show significant LDL-C efficacy and acceptable safety for NEXLETOL in these subgroups.
  • The approval of NEXLETOL was supported by a global pivotal Phase 3 LDL-C-lowering program conducted in more than 3,000 patients with ASCVD and/or HeFH.
  • In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering when used with moderate or high-intensity statins.