Shares of Amarin surged 23% in after-hours trading on Thursday after it reported favorable and statistically significant top-line results from Protocol Number EDPC003R01, its Phase 3 clinical trial of Vascepa (icosapent ethyl) conducted in China by its partner, Edding.
Amarin (AMRN) stated the study, which is evaluating Vasepa as a high triglyceride treatment, achieved the primary endpoint of a statistically significant percent change in triglyceride levels from baseline to week 12 for the 4 gram per day dose group. Additionally, the drug appeared to be well-tolerated and had a similar safety profile compared to the placebo, with no treatment-related serious adverse events observed.
EDPC003R01 was designed as a multi-center, randomized, double-blind, placebo-controlled, 12-week pivotal study in adult patients in China with qualifying fasting triglyceride (TG) levels greater than or equal to 500 mg/dL and less than or equal to 2000 mg/dL. Before the randomization into the 12-week double-blind treatment period took place, all of the patients went through a six to eight-week washout period of lipid altering drugs, as well as diet and lifestyle stabilization.
These results were consistent with the findings from Amarin’s MARINE study in a similar patient population, which were published in 2011. This data served as the basis for Vasepa’s initial U.S. approval for triglyceride lowering before the successful results of the REDUCE-IT cardiovascular outcomes study.
“We are proud to share news of these positive data from our partner’s pivotal Phase 3 clinical study of VASCEPA in China. Elevated triglycerides are a known marker of risk for pancreatitis and for cardiovascular disease. The statistically significant reduction in TG levels seen with the VASCEPA 4 gram per day dose in the study highlights its potential to address an unmet medical need in China, where hypertriglyceridemia is on the rise,” Amarin senior vice president and president, research & development and chief scientific officer, Steven Ketchum, Ph.D., commented.
Going forward, the data is being prepared to support Edding’s filing for regulatory approval of Vascepa in Mainland China. (See Amarin stock analysis on TipRanks)
Prior to the update, Piper Sandler analyst Yasmeen Rahimi trimmed the stock’s price target from $21 to $19 (319% upside potential), and reiterated a Buy rating. She told clients that despite the launch of a generic drug, she is bullish on its revenue growth potential, highlighting the “substantial” EU opportunity, three clinical studies evaluating Vascepa in COVID-19 and the further REDUCE-IT analyses at upcoming medical conferences.
Although shares have plummeted 79% year-to-date, analysts remain cautiously optimistic. Its Moderate Buy consensus rating breaks down into 6 Buys and 5 Holds. The average price target stands at $10.30, suggesting 127% upside potential.
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