Atherosclerosis - Pipeline Insight, 2024

This “Atherosclerosis - Pipeline Insight, 2024” report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Atherosclerosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Atherosclerosis: Understanding

Atherosclerosis: Overview

Atherosclerosis is a chronic inflammatory disease of the arteries and is the underlying cause of about 50% of all deaths in westernized society. It is principally a lipid-driven process initiated by the accumulation of low-density lipoprotein and remnant lipoprotein particles and an active inflammatory process in focal areas of arteries particularly at regions of disturbed non-laminar flow at branch points in the arteries and is considered a primary cause of atherosclerotic cardiovascular disease (ASCVD) resulting in heart attacks, stroke and peripheral arterial disease. In this review, we outline the vascular biology, sequelae and potential management. Atherosclerosis mainly develops through the continuous process of arterial wall lesions due to lipid retention by trapping in the intima by a matrix such as proteoglycans resulting in a modification which, in turn, aggravates chronic inflammation at vulnerable sites in the arteries and plays an important role at all phases of the atherogenic progression. This process begins from the nascent fatty streaks in the arterial intima which evolve into fibrous plaques and emerges into complex atherosclerotic lesions that are susceptible to rupture. Also, stenosis from the inward expansion of the atheroma can result in occlusion of vessels such as the coronaries. However symptomatic disease can be mitigated by exuberant collateral circulation.

Atherosclerosis is of multifactorial etiology. The most common risk factors include hypercholesterolemia (LDL-cholesterol), hypertension, diabetes mellitus, cigarette smoking, age (male older than 45 years and female older than 55 years), male gender, and strong family history (male relative younger than 55 years and female relative younger than 65 years. Also, a sedentary lifestyle, obesity, diets high in saturated and trans-fatty acids, and certain genetic mutations contribute to risk. While a low level of high-density lipoprotein (HDL)-cholesterol is considered a risk factor, pharmacological therapy increasing HDL-cholesterol has yielded negative results raising concerns about the role of HDL in ASCVD.

In the assessment of ASCVD risk factors, measuring the lipid profile (LDL-cholesterol), plasma glucose, and high-sensitivity C-reactive protein (hsCRP) (in certain instances) is reasonable. Ultrasound of the abdomen to screen for an abdominal aneurysm is indicated in the elderly especially with other ASCVD risk factors. For the noninvasive assessment of ASCVD, computed tomography (CT) angiography is evolving as a promising approach. Moreover, CT angiography can be used to detect the presence of low-attenuated plaques and in predicting future acute coronary events. In addition to CT angiography, new imaging techniques like cardiovascular magnetic resonance imaging (cardiac MRI) may prove useful in certain patients. However, cost needs to be balanced with need given the burgeoning increasing healthcare costs.

The best management of ASCVD is to treat the risk factors such as elevated LDL-C, blood pressure (BP), diabetes, among others. The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) are the mainstay to lower LDL cholesterol and reduce cardiovascular events and mortality. For clinical ASCVD, revascularization procedures are warranted such as angioplasties, bypass, among others. Also, thrombolysis is also a therapeutic option for CVA, acute limb ischemia from a thrombus/embolus.

"Atherosclerosis - Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Atherosclerosis pipeline landscape is provided which includes the disease overview and Atherosclerosis treatment guidelines. The assessment part of the report embraces, in depth Atherosclerosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Atherosclerosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Atherosclerosis R&D. The therapies under development are focused on novel approaches to treat/improve Atherosclerosis.

Atherosclerosis Emerging Drugs Chapters

This segment of the Atherosclerosis report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Atherosclerosis Emerging Drugs

Olpasiran: Amgen

Olpasiran is a first-in-class, synthetic, double-stranded, N-acetylgalactosamine-conjugated small interfering RNA (siRNA) designed to directly inhibit LPA messenger RNA translation in hepatocytes and potently reduce plasma Lp(a) concentration. Olpasiran reduced Lp(a) concentrations in transgenic mice and cynomolgus monkeys in a dose-responsive manner, achieving up to over 80% reduction from baseline for 5-8 weeks after administration of a single dose. Olpasiran is targeted to the liver via an N-acetylgalactosamine moiety that binds to the asialoglycoprotein receptor on the hepatic cell surface. RNA interference with olpasiran is a promising treatment approach that led to a profound and sustained reduction in Lp(a) concentration in Phase II clinical trial. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Atherosclerosis.

SLN360: Silence Therapeutics

SLN360 is a gene silencing therapy developed by Silence Therapeutics, designed to temporarily block the expression of the LPA gene, which produces lipoprotein(a) (Lp(a)). By silencing LPA, the levels of Lp(a) are lowered, which is expected to reduce the risk of heart diseases, heart attacks, and strokes. SLN360 is being studied in the APOLLO clinical trial program, and the results have shown that it can reduce Lp(a) levels by up to 98% in healthy adults with high Lp(a) levels, with reductions persisting at 150 days. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Atherosclerotic Cardiovascular Disease.

VERVE-101: Verve Therapeutics

VERVE-101 is a novel, investigational gene editing medicine designed to be a single course treatment that permanently turns off the PCSK9 gene in the liver to reduce disease-driving low-density lipoprotein cholesterol (LDL-C). VERVE-101 is being developed initially as a treatment for patients with heterozygous familial hypercholesterolemia (HeFH), a prevalent and potentially life-threatening subtype of atherosclerotic cardiovascular disease (ASCVD). VERVE-101 consists of messenger RNA expressing an adenine base editor and an optimized guide RNA targeting the PCSK9 gene packaged in an engineered lipid nanoparticle. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Atherosclerotic Cardiovascular Disease.

Atherosclerosis: Therapeutic Assessment

This segment of the report provides insights about the different Atherosclerosis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Atherosclerosis

There are approx. 15+ key companies which are developing the therapies for Atherosclerosis. The companies which have their Atherosclerosis drug candidates in the most advanced stage, i.e. Phase III include, Amgen.

Phases

The report covers around 20+ products under different phases of clinical development like:

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of:
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Atherosclerosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as:

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as:

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Atherosclerosis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Atherosclerosis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Atherosclerosis drugs.

Atherosclerosis Report Insights

• Atherosclerosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Atherosclerosis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Atherosclerosis drugs?
• How many Atherosclerosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Atherosclerosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Atherosclerosis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Atherosclerosis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Novo Nordisk
• Amgen
• Merck Sharp & Dohme
• Afimmune
• Silence Therapeutics
• Verve Therapeutics
• 858 Therapeutics
• Abionyx Pharma
• Bitterroot Bio

Key Products

• Ziltivekimab
• Olpasiran
• MK-0616
• Epeleuton
• SLN360
• VERVE-101
• Research Programme QPCT/L modulators
• CER-209
• BRB-002

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