Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced that target patient enrollment has been reached in its REDUCE-IT cardiovascular outcomes trial of Vascepa (icosapent ethyl). Amarin also announced that the onset of approximately 60% of the target aggregate number of primary cardiovascular events within the REDUCE-IT study has triggered preparation for a pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee (DMC). Amarin currently expects the independent interim analysis to be conducted in approximately six months.
Enrollment Target Achieved
The REDUCE-IT study was designed to enroll approximately 8,000 patients. This enrollment target has been reached and Amarinis winding down patient enrollment on a country by country basis. Since the study commenced in 2011, over 20,000 patient years of study have been accumulated in REDUCE-IT.
“We are pleased to announce that we have reached the target enrollment in REDUCE-IT, the first multinational cardiovascular outcomes study prospectively designed to investigate whether there is a meaningful reduction in the occurrence of major cardiovascular events when EPA is added to statin therapy in high-risk patients with elevated triglycerides,” said Steven Ketchum, Ph.D., president of research and development and chief scientific officer at Amarin. “Vascepa demonstrated a broad spectrum of favorable effects on lipid, lipoprotein, and inflammatory biomarkers compared to placebo in Phase 3 studies focused on patients with high triglyceride levels after statin therapy and on patients with very high triglyceride levels. Through long-term study of patients treated with Vascepa in REDUCE-IT, we aim to provide a robust dataset to determine whether the effects of highly-pure EPA omega-3 prescription drug therapy will lower the risk of cardiovascular events in the high-risk patient population studied.”
Interim Analysis Expected in Approximately Six Months
The REDUCE-IT study’s event rate continues to track to prior estimates. A pre-specified interim efficacy and safety analysis was designed to be conducted upon achieving approximately 60% of the 1,612 aggregate primary cardiovascular events within the study. REDUCE-IT patients are in the process of completing a study visit over the next several months, after which additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. As is typical for large-scale, multi-national studies, regardless of the strength of the study results this data preparation and transfer process is expected to take several months. The DMC’s analysis is anticipated to occur in approximately six months.
Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study until after the study is ready to be stopped either at the interim analysis or at the final analysis. Guidelines for the independent DMC to recommend stopping the study for overwhelming efficacy require that the study achieve statistical significance on the primary endpoint and generate robust findings on certain, pre-specified secondary outcome measures. Given the high thresholds of overwhelming efficacy required prior to a DMC recommending an early stop to a cardiovascular outcomes trial like REDUCE-IT, Amarin continues to expect that the DMC’s interim analysis will result in a recommendation to continue the REDUCE-IT study as planned. Such a recommendation is most common for cardiovascular outcome studies.
First Multinational Outcomes Study to Evaluate Cardiovascular Benefit of High-Dose EPA Therapy as an Add-on to Statin Therapy
Heart disease remains the number one cause of death in the United States. REDUCE-IT is the first multinational outcomes study being conducted to evaluate the cardiovascular benefits of treating patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels.
“In many high-risk patients with cardiovascular disease, substantial residual risk for events remains despite optimal LDL-cholesterol reduction with statin therapy,” said Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart and Vascular Center, Professor of Medicine, Harvard Medical School, and Principal Investigator for REDUCE-IT. “By design, the REDUCE-IT study has enrolled patients with high cardiovascular risk and elevated triglyceride levels despite statin therapy and will provide important information regarding the potential for high-dose EPA-only omega-3 therapy to confer incremental cardiovascular benefit beyond statin control of LDL-cholesterol.”
Amarin believes that the REDUCE-IT study is positioned for success based on extensive review of existing data from clinical, epidemiologic and genetic studies. With the study’s event rate tracking on schedule, the onset of the 1,612th primary cardiovascular event is expected to occur in 2017 with the publication of results anticipated in 2018.(Original Source)
Shares of Amarin Corporation Plc closed yesterday at $1.50, up $0.01 or 0.67%. AMRN has a 1-year high of $2.80 and a 1-year low of $1.24. The stock’s 50-day moving average is $1.46 and its 200-day moving average is $1.78.
On the ratings front, Amarin has been the subject of a number of recent research reports. In a report issued on February 26, H.C. Wainwright analyst Andrew Fein reiterated a Buy rating on AMRN, with a price target of $10, which represents a potential upside of 566.7% from where the stock is currently trading. Separately, on December 9, Oppenheimer’s Akiva Felt assigned a Hold rating to the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Akiva Felt have a total average return of 1.9% and -1.1% respectively. Fein has a success rate of 43.0% and is ranked #1261 out of 3775 analysts, while Felt has a success rate of 32.6% and is ranked #2975.
Amarin Corp. Plc is a biopharmaceutical company, which engages in the commercialization and development of therapeutics to improve cardiovascular health. Its product, Vascepa capsules, is use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The company was founded by Geoffrey W. Guy on March 1, 1989 and is headquartered in Dublin, Ireland.