CLINICAL TRIALS PROFILE FOR VASCEPA

All Clinical Trials for VASCEPA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02719327 ↗	Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid	Active, not recruiting	University of Wisconsin, Madison	Phase 2/Phase 3	2017-06-08	The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.
NCT02719327 ↗	Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid	Active, not recruiting	VA Office of Research and Development	Phase 2/Phase 3	2017-06-08	The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.
NCT02781584 ↗	Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)	Completed	Gilead Sciences	Phase 2	2016-07-13	The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
NCT02422446 ↗	Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects	Terminated	Brigham and Women's Hospital	Phase 3	2015-04-01	This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.
NCT02113163 ↗	PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA	Unknown status	Thetis Pharmaceuticals LLC	Phase 1	2014-03-01	The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.

Clinical Trial Conditions for VASCEPA

Condition Name

Condition Name for VASCEPA
Intervention	Trials
Hypertriglyceridemia	4
Cardiovascular Diseases	2
Eicosapentaenoic Acid	2
Endoscopic Surgery	2

Condition MeSH

Condition MeSH for VASCEPA
Intervention	Trials
Hypertriglyceridemia	5
Colorectal Neoplasms	3
Colonic Neoplasms	2
Atherosclerosis	2

Clinical Trial Locations for VASCEPA

Trials by Country

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−

Trials by Country for VASCEPA
Location	Trials
United States	22
United Kingdom	2
Canada	2
New Zealand	1

Trials by US State

+

−

Trials by US State for VASCEPA
Location	Trials
Massachusetts	4
California	3
Florida	2
Louisiana	2
Virginia	1

Clinical Trial Progress for VASCEPA

Clinical Trial Phase

Clinical Trial Phase for VASCEPA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for VASCEPA
Clinical Trial Phase	Trials
Recruiting	7
Completed	4
Active, not recruiting	2

Clinical Trial Sponsors for VASCEPA

Sponsor Name

Sponsor Name for VASCEPA
Sponsor	Trials
Canadian Medical and Surgical Knowledge Translation Research Group	2
National Institutes of Health (NIH)	2
Massachusetts General Hospital	2

Sponsor Type

Sponsor Type for VASCEPA
Sponsor	Trials
Other	27
Industry	7
NIH	3

VASCEPA: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to VASCEPA

VASCEPA, also known as icosapent ethyl, is a prescription medication that has made significant strides in the treatment of cardiovascular disease. It is the first and only FDA-approved medication to lower cardiovascular risk in addition to other medications, such as statins, in patients with heart disease or diabetes and other risk factors[4].

Clinical Trial Results: REDUCE-IT and Beyond

REDUCE-IT Trial

The landmark REDUCE-IT trial, published in the New England Journal of Medicine in 2018, was a pivotal study that demonstrated the efficacy of VASCEPA in reducing cardiovascular events. This trial involved over 8,000 statin-treated patients with high triglycerides and lasted nearly five years. The results showed that patients treated with VASCEPA had fewer cardiovascular events (17.2%) compared to those who took a placebo (22%), resulting in a 25% reduction in the risk of life-threatening cardiovascular events such as heart attacks or strokes[1].

Additional Analyses and Trials

Recent analyses from the REDUCE-IT trial have further reinforced the benefits of VASCEPA. For instance, in a prespecified subgroup of patients with metabolic syndrome but without diabetes at baseline, the addition of VASCEPA significantly reduced the risk of first and total cardiovascular events. This subgroup, almost exclusively comprising patients with established cardiovascular disease, saw a 41% reduction in total events compared to the placebo group[4].

The EVAPORATE trial, presented at the European Society of Cardiology (ESC) 2020 conference, also highlighted VASCEPA's effectiveness. This trial showed that VASCEPA reduced patients’ coronary plaque by 17% compared to placebo over 18 months, providing insights into the drug’s mechanism of action and its impact on coronary atherosclerosis[3].

Mechanism of Action

While the exact science of how VASCEPA works is not fully understood, clinical testing has led to proven clinical results. VASCEPA is believed to reduce cardiovascular risk through multiple factors, although the precise mechanisms are still under investigation[1].

Market Analysis

Global Expansion and Market Performance

Amarin Corporation, the manufacturer of VASCEPA, has been focusing on global expansion and securing reimbursement in new markets. Despite facing generic competition in the U.S., VASCEPA has maintained a significant market share. In the third quarter of 2024, VASCEPA sales grew 19% sequentially in Europe, driven primarily by Spain and the UK. In the U.S., the company has maintained over a 50% share of the IPE (icosapent ethyl) market, generating consistent cash flow of over $300 million per quarter over the last nine quarters[2].

Financial Performance and Growth Potential

Amarin's financial results indicate strong growth potential for VASCEPA. The company has seen a greater than 50% increase in the number of prescribers, resulting in over 80% growth in new prescriptions. This uptake is supported by outstanding clinical data and the ongoing education of healthcare providers about the benefits of VASCEPA[5].

Patent Protection and Competitive Landscape

VASCEPA has a strong intellectual property position, particularly in Europe, where it has received extended patent rights until 2039. This IP protection is crucial for sustaining revenue growth and maintaining market leadership against generic competition[5].

Market Projections

Global Expansion Efforts

Amarin is in the early phases of its global expansion effort, targeting key markets around the world. The company has already unlocked access and launched VASCEPA in some European markets and is working to advance access in additional critical markets. The recent securing of national pricing and reimbursement in Greece and Portugal is expected to contribute to incremental revenue growth[5].

Pricing and Reimbursement

The company is focused on advancing pricing and reimbursement opportunities in other key EU5 markets. In Italy, the dossier for VASCEPA is under review with local health authorities, and in France, additional data from the RESPECT-EPA cardiovascular outcome study is expected to strengthen the clinical dossier[5].

Outlook Against Generic Competition

Despite the loss of commercial exclusivity in the U.S., Amarin believes that branded VASCEPA will continue to be the market leader. The significant majority of VASCEPA's exclusive volume is in Medicare Part D plans, which are not impacted by the recent decision affecting commercial plans[5].

Impact on Cardiovascular Disease

Cardiovascular disease remains the number one killer globally, causing significant financial burdens and negatively impacting patients and their families. VASCEPA represents a critical option in reducing cardiovascular events, especially for patients who remain at high risk despite being on statin therapy. The reduction of cardiovascular events remains a top priority for healthcare providers, patients, and governments[5].

"Cardiovascular disease is an epidemic, and a 25% reduction in risk on top of statins is a very significant breakthrough." - Source: VASCEPA Clinical Trial Results[1]

Key Takeaways

• Clinical Efficacy: VASCEPA has demonstrated a significant reduction in cardiovascular events in clinical trials, including the landmark REDUCE-IT trial.
• Global Expansion: Amarin is actively expanding VASCEPA's reach globally, with notable growth in European markets.
• Market Performance: Despite generic competition, VASCEPA maintains a strong market share and generates significant revenue.
• Intellectual Property: Extended patent rights in Europe until 2039 provide a robust foundation for future growth.
• Impact on Cardiovascular Disease: VASCEPA is a crucial treatment option for reducing cardiovascular risk, especially for high-risk patients on statin therapy.

FAQs

What is VASCEPA and how does it work?

VASCEPA, or icosapent ethyl, is a prescription medication that reduces cardiovascular risk in patients with heart disease or diabetes and other risk factors. While the exact mechanism is not fully understood, it is believed to work through multiple factors to lower cardiovascular events.

What were the key findings of the REDUCE-IT trial?

The REDUCE-IT trial showed that patients treated with VASCEPA and a statin had fewer cardiovascular events (17.2%) compared to those who took a placebo (22%), resulting in a 25% reduction in the risk of life-threatening cardiovascular events.

How does VASCEPA compare to other treatments for high triglycerides?

VASCEPA is the first FDA-approved medication to lower cardiovascular risk in addition to other medications like statins. It has shown superior efficacy in reducing cardiovascular events compared to other treatments for high triglycerides.

What is the current market status of VASCEPA?

VASCEPA has maintained a significant market share in the U.S. and is growing in European markets. Despite generic competition, it continues to generate substantial revenue.

What are the future projections for VASCEPA's market performance?

With extended patent rights in Europe and ongoing global expansion efforts, VASCEPA is projected to continue its growth trajectory, contributing significantly to the reduction of cardiovascular events worldwide.

Sources

1. Clinical Trial Results | VASCEPA® (icosapent ethyl) - VASCEPA.
2. Amarin Reports Third Quarter 2024 Financial Results and Provides Business Update - Biospace.
3. ESC 2020: Amarin details positive Vascepa data amid looming generic competition - Clinical Trials Arena.
4. New REDUCE-IT® Analyses Show VASCEPA® (icosapent ethyl) Associated with 29 Percent Relative Risk Reduction Compared with Placebo in Prespecified Subgroup of Patients with Metabolic Syndrome but without Diabetes at Baseline - Biospace.
5. Earnings call: Amarin reports Q2 2024 results, eyes global Vascepa expansion - Investing.com.