Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced two EPA-related data presentations unveiled this week at the American Diabetes Association® 77th Scientific Sessions in San Diego, CA.
- A post-hoc analysis of the ANCHOR study further characterizing the efficacy and safety of prescription pure EPA Vascepa® (icosapent ethyl) in the subgroup of statin-treated women with persistent high triglycerides and diabetes mellitus type 2, showed that, compared with placebo, Vascepa reduced triglyceride levels and several other potentially atherogenic lipid parameters and inflammatory markers, and significantly increased blood EPA levels. The study titled, “Icosapent Ethyl in Statin-Treated Women with Persistent High Triglycerides and Diabetes Mellitus: ANCHOR Study Subanalysis,” was led by Eliot A. Brinton, MD, FAHA, FNLA.
- An in vitro mechanistic study suggesting that EPA may be a potential strategy for reducing blood vessel cell dysfunction is summarized in a published presentation, “Eicosapentaenoic Acid Reduces Small Dense Low-Density Lipoprotein Oxidation and Human Endothelial Dysfunction in Vitro in a Manner Distinct from Docosahexaenoic Acid,” by R. Preston Mason, PhD. The data demonstrated that EPA has antioxidant properties, distinct from DHA, that preserves certain cellular functions within blood vessel cells under disease-like conditions.
“Amarin continues to invest in research into the management of lipid disorders and patients at high risk of cardiovascular disease,” expressed Eliot A. Brinton, MD. “The post-hoc analysis of ANCHOR study data explores the potential benefits and side effects of a therapy for women with diabetes that could help improve patient care.” Amarin’s ANCHOR trial was a 12-week trial that studied the effects of Vascepa in adult patients at high risk for cardiovascular disease with persistent high triglyceride levels (≥200 mg/dL and < 500 mg/dL) after stable statin therapy.
The ANCHOR study analysis was conducted in light of the correlation between elevated triglycerides and diabetes in women. The Centers for Disease Prevention and Control has indicated that without major changes in our diet and lifestyle, as many as 1 in 3 US adults could have diabetes by 2050. Analysis of study data on women with diabetes is particularly important, since women have often been underrepresented in clinical trials of patients with diabetes.
As is typical with subgroup analyses, limitations of the ANCHOR data analysis include the relatively small sample size (n=146), the 12-week study length and the post-hoc study design. Nonetheless, the results show potentially valuable changes in triglyceride levels and other lipoprotein parameters and inflammatory markers with Vascepa compared with placebo. The efficacy and safety of Vascepa 4 g/day in women were consistent with the overall ANCHOR study results. Limitations of the mechanistic study data include the simplistic and hypothesis-generating nature of in vitro data.
Amarin’s clinical development program for Vascepa includes a trial known as the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (200-499 mg/dL). A large portion of the male and female patients enrolled in this outcomes study are anticipated to also be diagnosed with type 2 diabetes. Amarin recently announced that the REDUCE-IT study reached the onset of approximately 80% of the target aggregate number of primary cardiovascular events and that preparations are underway for an associated pre-specified interim efficacy analysis by the independent Data Monitoring Committee of REDUCE-IT. This analysis is expected to occur before the end of Q3 2017. Amarin expects that the trial will run to completion and that the onset of the target final primary cardiovascular event will likely be reached near the end of 2017.
Shares of Amarin are currently trading at $2.93, down $0.03 or -1.01%. AMRN has a 1-year high of $3.65 and a 1-year low of $1.90. The stock’s 50-day moving average is $3.02 and its 200-day moving average is $3.13.
Amarin Corp. Plc is a biopharmaceutical company, which engages in the commercialization and development of therapeutics for cardiovascular health. It has developed and markets Vascepa capsules through wholesale.