Amgen Announces Positive Top-Line Results from Phase III GAUSS-2 Trial of Evolocumab (AMG 145) in Statin Intolerant Patients with High Cholestero?l
Amgen has announced that the Phase III GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial evaluating evolocumab in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, compared with ezetimibe were consistent with results observed in the Phase II GAUSS study.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.1
The GAUSS-2 trial evaluated safety, tolerability and efficacy of evolocumab in 307 patients with high cholesterol who could not tolerate effective doses of at least two different statins due to muscle-related side effects. Patients were randomized to one of four treatment groups: subcutaneous evolocumab 140 mg every 2 weeks and oral placebo daily; subcutaneous evolocumab 420 mg monthly and oral placebo daily; subcutaneous placebo every 2 weeks and oral ezetimibe 10 mg daily; or subcutaneous placebo monthly and oral ezetimibe 10 mg daily.
Safety was generally balanced across treatment groups. The most common adverse events (> 5% in evolocumab combined group) were headache (7.8% evolocumab; 8.8% ezetimibe), myalgia (7.8% evolocumab; 17.6% ezetimibe), pain in extremity (6.8% evolocumab; 1.0% ezetimibe), and muscle spasms (6.3% evolocumab; 3.9% ezetimibe).
"We are pleased to continue to see promising results from the Phase III studies in our comprehensive development programme for evolocumab," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. "The positive GAUSS-2 results suggest that evolocumab may offer a new lipid-lowering treatment to meet an important medical need for high-risk patients who cannot tolerate effective doses of statins."
Data from the Phase III GAUSS-2 trial will be submitted to a future medical conference and for publication.
According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C.2 Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.3-4 Although statins are effective, it is estimated that 5–15% of patients cannot tolerate statins, primarily due to muscle-related side effects.5
References
1. Amgen Data on File, Investigator Brochure.
2. www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp. Accessed November 2013.
4. World Health Organization. Global status report on noncommunicable diseases 2010. Geneva, 2011.
5. Fernandez G, Spatz ES, Jablecki C, Phillips PS. "Statin myopathy: a common dilemma not reflected in clinical trials." Cleve Clin J Med. 2011;78:393-403.
Related News
-
News CPHI Podcast Series: the power of digital marketing in pharma
Digital marketing is a valuable tool for many industries, and the pharmaceutical and healthcare industry is no exception. The CPHI Podcast Series covers how marketing can be used by companies to increase their engagement and overcome challenges.&n... -
News Novel approach to creating sustainable packaging from rice husks
Researchers have created a new approach to the designing of eco-friendly nanofibres extracted from rice husks, addressing the critical need for sustainable packaging materials in food and biopharmaceutical products. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance